Clincosm LogoSign in Get a demo

SPAF: Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT03441633
Collaborator
(none)
51,690
Enrollment
1
Location
12.6
Actual Duration (Months)
4097.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Apixaban is a direct anticoagulant, which inhibits the factor Xa. Its clinical efficiency in prevention of stroke and systemic embolism in adult patients with NVAF (non/valvular atrial fibrillation) was demonstrated as well as has shown better safety profile compared with warfarin. A Drug Utilization study will evaluate whether this drug has been used in accordance with the approved indication and recommendations described in the summary of product characteristics (SmPC) and estimate possible misuse or overuse apixaban.

Condition or Disease Intervention/Treatment Phase

Detailed Description

The primary research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA.

In addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed.

Objective 1: To characterize patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban.

Objective 2: Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC.

Objective 3: Describe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendations.

Objective 4: Estimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and rivaroxaban cohort.

Objective 5: To analyze INR (International Normalized Ratio) values during the last 12 months and to obtain TTR (Time in Therapeutic Range) values in patients previously treated with VKA, and during the whole study period for those in the cohort treated with VKA.

Study Design

Study Type:
Observational
Actual Enrollment :
51690 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
APIXABAN DRUG UTILIZATION STUDY IN STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF)
Actual Study Start Date :
Feb 18, 2016
Actual Primary Completion Date :
Mar 8, 2017
Actual Study Completion Date :
Mar 8, 2017

Arms and Interventions

Arm Intervention/Treatment
Group 1. Apixaban

Patients who are on treatment with apixaban. 1a. patients who have initiated with apixaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 1b. patients who previously have been treated with VKA in the 12 months before index date.

Drug: apixaban
current or new medication
Group 2. VKA

Patients who are on treatment with VKA. 2a. patients who have initiated with VKA as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 2b. patients who previously have been treated with VKA in the 12 months before index date.

Drug: VKA
current or new medication
Group 3. Dabigatran

Patients who are on treatment with dabigatran. 3a. patients who have initiated with dabigatran as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 3b. patients who previously have been treated with VKA in the 12 months before index date.

Drug: dabigatran
current or new medication
Group 4. Rivaroxaban

Patients who are on treatment with rivaroxaban. 4a. patients who have initiated with rivaroxaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 4b. patients who previously have been treated with VKA in the 12 months before index date.

Drug: rivaroxaban
current or new medication

Outcome Measures

Primary Outcome Measures

  1. Number of Participants by Their Sociodemographic Characteristics: Smoking Habit [Day 1]

    Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.

  2. Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit [Day 1]

    Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.

  3. Number of Participants by Their Sociodemographic Characteristics: MEDEA [Day 1]

    Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.

  4. Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) [Day 1]

    Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2).

  5. Number of Participants by Comorbidity [Up to 12 months after date of first prescription]

    Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.

  6. Risk of Bleeding Events: HAS-BLED Score [Up to 12 months prior to enrollment]

    Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and >3 = high risk of bleed per 100 participants-year.

  7. Risk of Thromboembolic Events: CHADS2 Score [Up to 12 months prior to enrollment]

    Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age >=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.

  8. Risk of Thromboembolic Events: CHA2DS2Vasc Score [Up to 12 months prior to enrollment]

    Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, >=65 and <75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age >=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.

  9. Number of Participants by Comedications [Up to 30 days after date of first prescription]

    Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.

  10. Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) [Up to 12 months after date of first prescription]

    MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as <80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as >120% of MPR.

  11. Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year [Up to 12 months after date of first prescription]

    Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.

  12. Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) [Up to 12 months after date of first prescription]

    NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.

  13. International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA [Up to 12 months after date of first prescription]

    INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).

  14. Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA [Up to 12 months after date of first prescription]

    TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Patients more than 18 years-old.

  2. Patients diagnosed with NVAF registered in primary care according to ICD-10.

  3. Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA experienced), dabigatran or rivaroxaban for the SPAF indication.

  4. Continuous enrolment in the 12 months pre-index.

Exclusion Criteria:

  1. Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including patients with mitral prosthetic valves.

  2. Lost to follow-up (e.g. transfer to primary care center non-ICS).

Contacts and Locations

Locations

Site City State Country Postal Code
1 IDIAP Jordi Gol Barcelona Cataluña Spain 8007

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03441633
Other Study ID Numbers:
  • B0661076
  • SPAF
First Posted:
Feb 22, 2018
Last Update Posted:
Apr 19, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Pfizer
atrial fibrillation
apixaban
stroke
Additional relevant MeSH terms:
Atrial Fibrillation
Rivaroxaban
Apixaban
Dabigatran

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Period Title: Overall Study
STARTED 4712 1423 32212 192 2286 363 2855 953 5132 1562
COMPLETED 4712 1423 32212 192 2286 363 2855 953 5132 1562
NOT COMPLETED 0 0 0 0 0 0 0 0 0 0

Baseline Characteristics

Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive Total
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA, apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician. Total of all reporting groups
Overall Participants 4712 1423 32212 192 2286 363 2855 953 5132 1562 51690
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
71.8
(11.1)
78.1
(8.7)
73.5
(12.3)
74.6
(10.7)
69.7
(13.4)
74.9
(12.9)
69.9
(12.3)
76.5
(9.5)
69.3
(13.2)
76.4
(10.5)
72.8
(12.3)
Sex: Female, Male (Count of Participants)
Female
2661
56.5%
751
52.8%
15531
48.2%
94
49%
979
42.8%
205
56.5%
1399
49%
479
50.3%
2649
51.6%
811
51.9%
25559
49.4%
Male
2051
43.5%
672
47.2%
16681
51.8%
98
51%
1307
57.2%
158
43.5%
1456
51%
474
49.7%
2483
48.4%
751
48.1%
26131
50.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%

Outcome Measures

1. Primary Outcome
Title Number of Participants by Their Sociodemographic Characteristics: Smoking Habit
Description Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.
Time Frame Day 1

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 4712 1423 32212 192 2286 363 2855 953 5132 1562
Missing
207
4.4%
23
1.6%
1844
5.7%
7
3.6%
112
4.9%
14
3.9%
225
7.9%
23
2.4%
354
6.9%
38
2.4%
Non-smoker
3104
65.9%
946
66.5%
19440
60.4%
119
62%
1166
51%
234
64.5%
1684
59%
623
65.4%
3079
60%
1030
65.9%
Ex-smoker
459
9.7%
83
5.8%
3676
11.4%
16
8.3%
320
14%
26
7.2%
355
12.4%
72
7.6%
608
11.8%
102
6.5%
Smoker
942
20%
371
26.1%
7252
22.5%
50
26%
688
30.1%
89
24.5%
591
20.7%
235
24.7%
1091
21.3%
392
25.1%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.68 to 0.82
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.14 to 1.52
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.93 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.755
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.80 to 1.13
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.426
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
0.95 to 1.83
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.930
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.77 to 1.12
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.72 to 0.84
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
1.10 to 1.42
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.98 to 1.19
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.755
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.84 to 1.14
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.426
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.84 to 1.52
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.930
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.81 to 1.12
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.74 to 0.84
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
1.08 to 1.32
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
1.08 to 1.26
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.755
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.60 to 1.13
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.426
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
0.82 to 2.52
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.930
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.70 to 1.40
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.49 to 0.60
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.29 to 1.76
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.72
Confidence Interval (2-Sided) 95%
1.54 to 1.93
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.755
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.72 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.426
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.78 to 1.95
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in naive participants (Smoker)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.930
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.70 to 1.20
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
Title Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit
Description Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.
Time Frame Day 1

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 4712 1423 32212 192 2286 363 2855 953 5132 1562
Missing
2162
45.9%
353
24.8%
11299
35.1%
40
20.8%
839
36.7%
91
25.1%
1263
44.2%
211
22.1%
2475
48.2%
366
23.4%
No intake
1749
37.1%
810
56.9%
14337
44.5%
111
57.8%
984
43%
212
58.4%
1054
36.9%
550
57.7%
1696
33%
923
59.1%
Moderate intake
765
16.2%
247
17.4%
6241
19.4%
39
20.3%
447
19.6%
58
16%
505
17.7%
187
19.6%
915
17.8%
255
16.3%
Risk consumption
36
0.8%
13
0.9%
335
1%
2
1%
16
0.7%
2
0.6%
33
1.2%
5
0.5%
46
0.9%
18
1.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (No intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.90 to 1.09
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.98 to 1.25
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.164
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
0.94 to 2.45
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (No intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.826
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.87 to 1.22
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.190
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.94 to 1.43
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.526
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.18 to 1.57
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (No intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.77 to 0.91
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
1.01 to 1.24
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.164
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.76 to 1.83
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (No intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.826
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.95 to 1.26
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.190
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.77 to 1.13
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.526
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.62 to 2.65
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (No intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
1.28 to 1.45
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
1.14 to 1.35
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.164
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.98 to 1.95
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (No intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.826
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.76 to 1.41
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.190
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.82 to 1.76
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.526
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.17 to 4.50
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (No intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
1.16 to 1.42
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
1.10 to 1.43
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.164
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.49 to 1.64
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (No intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.826
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.84 to 1.34
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.190
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.66 to 1.23
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.526
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.09 to 2.36
Parameter Dispersion Type:
Value:
Estimation Comments
3. Primary Outcome
Title Number of Participants by Their Sociodemographic Characteristics: MEDEA
Description Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.
Time Frame Day 1

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here, "Overall Number of Participants Analyzed (N)" signifies participants who were evaluable for this outcome measure.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 4027 1210 25477 154 2163 322 2393 789 4430 1389
Missing - Urban area
190
4%
90
6.3%
1754
5.4%
16
8.3%
120
5.2%
28
7.7%
110
3.9%
57
6%
230
4.5%
145
9.3%
Quintile 1 - Urban area
716
15.2%
224
15.7%
4735
14.7%
31
16.1%
149
6.5%
73
20.1%
558
19.5%
156
16.4%
973
19%
230
14.7%
Quintile 2 - Urban area
754
16%
216
15.2%
4753
14.8%
25
13%
315
13.8%
73
20.1%
461
16.1%
148
15.5%
803
15.6%
234
15%
Quintile 3 - Urban area
825
17.5%
256
18%
4801
14.9%
27
14.1%
606
26.5%
52
14.3%
447
15.7%
137
14.4%
904
17.6%
230
14.7%
Quintile 4 - Urban area
807
17.1%
231
16.2%
4744
14.7%
28
14.6%
635
27.8%
55
15.2%
429
15%
152
15.9%
837
16.3%
300
19.2%
Quintile 5 - Urban area
735
15.6%
193
13.6%
4690
14.6%
27
14.1%
338
14.8%
41
11.3%
388
13.6%
139
14.6%
683
13.3%
250
16%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
1.20 to 1.53
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.014
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.89 to 1.15
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.77 to 0.99
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.75 to 0.97
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.013
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.74 to 0.97
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.157
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.84 to 1.31
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.124
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.82 to 1.29
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.062
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.61 to 0.96
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.079
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.78 to 1.22
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.140
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.86 to 1.38
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
1.17 to 1.45
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.014
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.87 to 1.09
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.91 to 1.12
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.85 to 1.05
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.013
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.74 to 0.93
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.157
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.76 to 1.13
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.124
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.81 to 1.20
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.062
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.65 to 0.96
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.079
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
1.02 to 1.48
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.140
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.99 to 1.49
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.88 to 1.05
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.014
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.84 to 0.99
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.76 to 0.90
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.77 to 0.91
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.013
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.85 to 1.00
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.157
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.68 to 1.54
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.124
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.53 to 1.29
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.062
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.48 to 1.13
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.079
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.57 to 1.33
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.140
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.67 to 1.59
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.32 to 0.47
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.014
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.73 to 0.97
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
1.51 to 1.91
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.86
Confidence Interval (2-Sided) 95%
1.65 to 2.10
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.013
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.82 to 1.08
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.157
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
1.00 to 1.80
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.124
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.04 to 1.88
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.062
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.55 to 1.05
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.079
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.67 to 1.26
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.140
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.56 to 1.15
Parameter Dispersion Type:
Value:
Estimation Comments
4. Primary Outcome
Title Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)
Description Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2).
Time Frame Day 1

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 4712 1423 32212 192 2286 363 2855 953 5132 1562
Missing
1424
30.2%
261
18.3%
6898
21.4%
34
17.7%
509
22.3%
87
24%
960
33.6%
178
18.7%
1746
34%
311
19.9%
18.5 - 25 kg per m^2 (Normal)
423
9%
253
17.8%
4471
13.9%
30
15.6%
295
12.9%
78
21.5%
272
9.5%
144
15.1%
464
9%
271
17.3%
Less than (<) 18.5 kg per m^2 (Underweight)
12
0.3%
6
0.4%
141
0.4%
0
0%
6
0.3%
2
0.6%
10
0.4%
8
0.8%
16
0.3%
0
0%
25 - 30 kg per m^2 (Overweight)
1229
26.1%
493
34.6%
10074
31.3%
68
35.4%
712
31.1%
119
32.8%
735
25.7%
306
32.1%
1289
25.1%
482
30.9%
Greater than (>) 30 kg per m^2 (Obese)
1624
34.5%
410
28.8%
10628
33%
60
31.3%
764
33.4%
77
21.2%
878
30.8%
317
33.3%
1617
31.5%
498
31.9%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.91 to 1.25
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.202
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.38
Confidence Interval (2-Sided) 95%
0.58 to 3.23
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.88 to 1.09
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.003
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.76 to 0.93
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.083
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.66 to 1.03
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.011
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.99
Confidence Interval (2-Sided) 95%
0.68 to 6.18
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.227
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.75 to 1.06
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
1.03 to 1.47
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.88 to 1.16
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.202
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.58 to 2.66
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.87 to 1.04
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.003
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.80 to 0.95
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.083
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.80 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.011
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
0.02 to 1.05
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.227
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.72 to 0.98
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.99 to 1.35
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.63
Confidence Interval (2-Sided) 95%
1.47 to 1.82
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.202
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
0.98 to 3.25
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
1.20 to 1.38
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.003
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.88 to 1.00
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.083
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.56 to 1.28
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.011
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.13 to 8.58
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.227
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.75 to 1.42
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.81 to 1.55
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
1.28 to 1.76
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.202
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.36 to 2.73
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
1.15 to 1.43
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.003
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.86 to 1.06
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.083
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.95 to 1.68
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.011
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
0.18 to 6.21
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.227
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.72 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.50 to 0.87
Parameter Dispersion Type:
Value:
Estimation Comments
5. Primary Outcome
Title Number of Participants by Comorbidity
Description Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.
Time Frame Up to 12 months after date of first prescription

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 4712 1423 32212 192 2286 363 2855 953 5132 1562
Count of Participants [Participants]
3695
78.4%
1316
92.5%
26450
82.1%
173
90.1%
1819
79.6%
318
87.6%
2030
71.1%
870
91.3%
3731
72.7%
1417
90.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.61 to 0.75
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.052
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.63 to 1.15
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.67 to 0.80
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.052
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.61 to 1.03
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocumarol vs. Apixaban in naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
1.17 to 1.36
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocumarol vs. Apixaban in non-naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.052
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.45 to 1.27
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.95 to 1.21
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.052
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.40 to 0.84
Parameter Dispersion Type:
Value:
Estimation Comments
6. Primary Outcome
Title Risk of Bleeding Events: HAS-BLED Score
Description Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and >3 = high risk of bleed per 100 participants-year.
Time Frame Up to 12 months prior to enrollment

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 4712 1423 32212 192 2286 363 2855 953 5132 1562
Mean (Standard Deviation) [bleed per 100 participants-year]
1.7
(1.0) 0%
2.7
(1.1) 0.2%
2.2
(1.1) 0%
2.5
(1.0) 1.3%
1.9
(1.1) 0.1%
2.4
(1.2) 0.7%
1.5
(1.0) 0.1%
2.6
(1.0) 0.3%
1.6
(1.0) 0%
2.6
(1.1) 0.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (HAS - BLED)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.26 to -0.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (HAS - BLED)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.001
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.18 to -0.01
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (HAS - BLED)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.23 to -0.15
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (HAS - BLED)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.001
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.19 to -0.04
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocumarol vs. Apixaban in naive participants (HAS - BLED)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.47 to 0.53
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocumarol vs. Apixaban in non-naive participants (HAS - BLED)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.001
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.32 to -0.02
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (HAS - BLED)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
0.12 to 0.23
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (HAS - BLED)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.001
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.37 to -0.10
Parameter Dispersion Type:
Value:
Estimation Comments
7. Primary Outcome
Title Risk of Thromboembolic Events: CHADS2 Score
Description Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age >=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.
Time Frame Up to 12 months prior to enrollment

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 4712 1423 32212 192 2286 363 2855 953 5132 1562
Mean (Standard Deviation) [stroke risk per year]
1.7
(1.3)
2.8
(1.4)
1.9
(1.3)
2.3
(1.3)
1.8
(1.3)
2.5
(1.5)
1.5
(1.3)
2.6
(1.4)
1.5
(1.2)
2.6
(1.4)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (CHADS2)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.24 to -0.12
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (CHADS2)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.35 to -0.12
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (CHADS2)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.28 to -0.18
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (CHADS2)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.31 to -0.11
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocumarol vs. Apixaban in naive participants (CHADS2)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
0.17 to 0.25
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocumarol vs. Apixaban in non-naive participants (CHADS2)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.70 to -0.30
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (CHADS2)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
0.01 to 0.14
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (CHADS2)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.54 to -0.20
Parameter Dispersion Type:
Value:
Estimation Comments
8. Primary Outcome
Title Risk of Thromboembolic Events: CHA2DS2Vasc Score
Description Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, >=65 and <75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age >=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.
Time Frame Up to 12 months prior to enrollment

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 4712 1423 32212 192 2286 363 2855 953 5132 1562
Mean (Standard Deviation) [stroke risk per year]
3.0
(1.7)
4.4
(1.6)
3.2
(1.7)
3.7
(1.6)
2.9
(1.8)
3.9
(1.9)
2.7
(1.8)
4.0
(1.7)
2.7
(1.7)
4.1
(1.7)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (CHA2DS2Vasc)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.42 to -0.26
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (CHA2DS2Vasc)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.46 to -0.19
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (CHA2DS2Vasc)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.45 to -0.32
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (CHA2DS2Vasc)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.39 to -0.15
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocumarol vs. Apixaban in naive participants (CHA2DS2Vasc)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
0.14 to 0.24
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocumarol vs. Apixaban in non-naive participants (CHA2DS2Vasc)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-0.86 to -0.37
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (CHA2DS2Vasc)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.18 to -0.01
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (CHA2DS2Vasc)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-0.64 to -0.21
Parameter Dispersion Type:
Value:
Estimation Comments
9. Primary Outcome
Title Number of Participants by Comedications
Description Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.
Time Frame Up to 30 days after date of first prescription

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 4712 1423 32212 192 2286 363 2855 953 5132 1562
Count of Participants [Participants]
4712
100%
1406
98.8%
32212
100%
188
97.9%
2286
100%
352
97%
2855
100%
947
99.4%
5132
100%
1532
98.1%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.008
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
0.77 to 5.30
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.008
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.33 to 1.12
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocumarol vs. Apixaban in non-naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.008
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.20 to 1.99
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.008
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.18 to 0.86
Parameter Dispersion Type:
Value:
Estimation Comments
10. Primary Outcome
Title Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)
Description MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as <80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as >120% of MPR.
Time Frame Up to 12 months after date of first prescription

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 424 430 6108 32 344 79 447 311 527 495
MPR: Poor adherence
162
3.4%
151
10.6%
5634
17.5%
31
16.1%
103
4.5%
57
15.7%
241
8.4%
177
18.6%
147
2.9%
131
8.4%
MPR: Good adherence
259
5.5%
276
19.4%
460
1.4%
0
0%
151
6.6%
13
3.6%
206
7.2%
133
14%
378
7.4%
360
23%
MPR: Over adherence
3
0.1%
3
0.2%
14
0%
1
0.5%
90
3.9%
9
2.5%
0
0%
1
0.1%
2
0%
4
0.3%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Poor adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.14 to 1.75
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Good adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.55 to 0.82
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Over adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.03 to 2.01
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Poor adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.58
Confidence Interval (2-Sided) 95%
1.23 to 2.04
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Good adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
0.34 to 0.57
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Over adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.02 to 3.73
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Poor adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.52 to 0.84
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Good adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.95 to 1.36
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Over adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.06 to 3.41
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Poor adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.50 to 0.85
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Good adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.90 to 1.37
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Over adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.22 to 5.85
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocumarol vs. Apixaban in naive participants (Poor adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.37
Confidence Interval (2-Sided) 95%
2.86 to 3.99
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocumarol vs. Apixaban in naive participants (Good adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
0.09 to 0.13
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocumarol vs. Apixaban in naive participants (Over adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.11 to 1.52
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocumarol vs. Apixaban in non-naive participants (Poor adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.78 to 1.91
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocumarol vs. Apixaban in non-naive participants (Good adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
0.00 to 0.09
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocumarol vs. Apixaban in non-naive participants (Over adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.07
Confidence Interval (2-Sided) 95%
0.07 to 18.00
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Poor adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.45 to 0.75
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Good adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.41 to 0.63
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in naive participants (Over adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 29.40
Confidence Interval (2-Sided) 95%
11.01 to 123.80
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Poor adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.91 to 1.86
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Good adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.05 to 0.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Over adherence)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.73
Confidence Interval (2-Sided) 95%
2.81 to 46.50
Parameter Dispersion Type:
Value:
Estimation Comments
11. Primary Outcome
Title Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year
Description Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.
Time Frame Up to 12 months after date of first prescription

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 1305 666 17434 117 1353 206 1449 559 1718 817
Count of Participants [Participants]
881
18.7%
236
16.6%
11326
35.2%
85
44.3%
1009
44.1%
127
35%
1002
35.1%
248
26%
1191
23.2%
322
20.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Discontinuation first year)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.92 to 1.27
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Discontinuation first year)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.15 to 1.83
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Discontinuation first year)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.93 to 1.27
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Discontinuation first year)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.96 to 1.47
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocumarol vs. Apixaban in naive participants (Discontinuation first year)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.79 to 1.01
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocumarol vs. Apixaban in non-naive participants (Discontinuation first year)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.82
Confidence Interval (2-Sided) 95%
3.14 to 7.55
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Discontinuation first year)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.19 to 1.67
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Discontinuation first year)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.92
Confidence Interval (2-Sided) 95%
2.12 to 4.05
Parameter Dispersion Type:
Value:
Estimation Comments
12. Primary Outcome
Title Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)
Description NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.
Time Frame Up to 12 months after date of first prescription

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 1305 666 17434 117 1353 206 1449 559 1718 817
Median (Inter-Quartile Range) [milligrams per day]
15.0
30.0
16.0
16.0
53.0
16.0
22.0
22.0
21.0
28.0
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (NDDDs)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.63
Confidence Interval (2-Sided) 95%
3.02 to 4.24
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (NDDDs)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.77 to 0.98
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (NDDDs)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
0.84 to 2.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (NDDDs)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.98
Confidence Interval (2-Sided) 95%
1.16 to 2.80
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocumarol vs. Apixaban in naive participants (NDDDs)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.41 to 1.39
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocumarol vs. Apixaban in non-naive participants (NDDDs)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.25
Confidence Interval (2-Sided) 95%
-4.32 to -0.18
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (NDDDs)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 28.52
Confidence Interval (2-Sided) 95%
27.56 to 29.48
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (NDDDs)
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.000
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.93
Confidence Interval (2-Sided) 95%
-1.05 to 4.90
Parameter Dispersion Type:
Value:
Estimation Comments
13. Primary Outcome
Title International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
Description INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).
Time Frame Up to 12 months after date of first prescription

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of VKA for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.
Arm/Group Title Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive
Arm/Group Description Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 19192 113 872 158
Mean (Standard Deviation) [ratio]
2.5
(0.4)
2.5
(0.4)
2.5
(0.3)
2.6
(0.4)
14. Primary Outcome
Title Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
Description TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).
Time Frame Up to 12 months after date of first prescription

Outcome Measure Data

Analysis Population Description
Study population included all participants with a first-recorded prescription of VKA for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.
Arm/Group Title Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive
Arm/Group Description Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Measure Participants 19192 113 872 158
Median (Inter-Quartile Range) [days]
60.2
59.6
66.2
58.9

Adverse Events

Time Frame Not applicable as safety data was not planned to be collected during the study
Adverse Event Reporting Description Safety data was not planned to be collected during the study.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA, apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
All Cause Mortality
Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Serious Adverse Events
Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer, Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03441633
Other Study ID Numbers:
  • B0661076
  • SPAF
First Posted:
Feb 22, 2018
Last Update Posted:
Apr 19, 2019
Last Verified:
Jan 1, 2019