Fracture Risk With Thiazolidinediones
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01055223
Collaborator
(none)
98,483
10
Study Details
Study Description
Brief Summary
Treatment with thiazolidinediones (TZD) has recently been reported to possibly increase the risk of fractures in a randomized trial exploring the efficacy of rosiglitazone (RSG), metformin, or glyburide encompassing 4360 patients with type 2 diabetes.
It is hypothesized that spironolactone, a diuretic that is broadly used for the treatment of fluid retention and edema associated with TZD, has a potential protective effect against bone fractures. However, to our knowledge, this has not been tested in diabetic patients treated with TZD. Amiloride is another diuretic that shares with spironolactone the anti mineralocorticoid ion gated channels activity and will be analysed in this study with regard to possible protective effect against bone fracture in combination with TZD.
This study is a nested case-control study conducted among type 2 diabetes subjects exposed to TZD. The study aims to explore if the risk of fracture is reduced among type 2 diabetic subjects exposed to spironolactone and TZD. The study will compare the odds of any low impact fracture, and hand, foot, upper arm, wrist, and hip fracture incidence in subjects treated with TZD+spironolactone and TZD+amiloride compared to subjects treated with TZD only.
The study population will consist of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months or at least 12 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO] or troglitazone) during their follow-up time available in the database.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.
Study Design
Study Type:
Observational
Actual Enrollment
:
98483 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
The Association Between Exposure to Spironolactone or Amiloride and Fracture Risk Among Subjects Treated With Thiazolidinediones
Study Start Date
:
May 1, 2009
Actual Primary Completion Date
:
Mar 1, 2010
Actual Study Completion Date
:
Mar 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Type 2 diabetes subjects Type 2 diabetes subjects |
Drug: TZD only (RSG or PIO or troglitazone)
Drug exposure will be inferred from prescription claims. Subjects who have been exposed to TZD for at least 6 months or at least 12 months will be considered for inclusion.
Drug: TZD + spironolactone
Subjects who have been exposed to TZD for at least 6 months or at least 12 months will be considered for inclusion.
In order to be eligible for inclusion in this category, the prescription days supply for TZD and spirinolactone must overlap by at least 30 days.
Drug: TZD + amiloride
Subjects who have been exposed to TZD for at least 6 months or at least 12 months will be considered for inclusion.
In order to be eligible for inclusion in this category, the prescription days supply for TZD and Amiloride must overlap by at least 30 days.
|
Outcome Measures
Primary Outcome Measures
- Number of Low Impact Fractures in Males and Females After 6 Months of Exposure to TZD [From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 and December 31, 2008]
ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.
- Number of Low Impact Fractures in Males and Females After 12 Months of Exposure to TZD [From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008]
ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.
Secondary Outcome Measures
- Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 6 Months of Exposure to TZD [From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008]
ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.
- Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 12 Months of Exposure to TZD [From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008]
ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.
- Number of Hip Fractures Combined in Males and Females After 6 Months of Exposure to TZD [From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008]
ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.
- Number of Hip Fractures Combined in Males and Females After 12 Months of Exposure to TZD [From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008]
ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
At least one ICD-9 code for type 2 diabetes
-
At least 6 months or at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database (The subject's study period begin date will be defined as the earliest date of their first TZD prescription. Subjects included in the study are required to have at least six months of follow-up time in the database prior to their first TZD prescription)
Exclusion Criteria:
-
Subjects with a diagnosis of Paget's disease and osteomalacia
-
A history of fracture, osteoporosis or cancer prior to the first prescription of TZD (study begin date)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01055223
Other Study ID Numbers:
- 113332
First Posted:
Jan 25, 2010
Last Update Posted:
May 30, 2017
Last Verified:
May 1, 2017
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | TZD 6-month Cohort (Including TZD 12-month Cohort) |
|---|---|
| Arm/Group Description | The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected. |
| Period Title: Overall Study | |
| STARTED | 98483 |
| COMPLETED | 98483 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | TZD 6-month Cohort (Including TZD 12-month Cohort) |
|---|---|
| Arm/Group Description | The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected. |
| Overall Participants | 98483 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
52.2
(8.33)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
37738
38.3%
|
| Male |
60745
61.7%
|
Outcome Measures
| Title | Number of Low Impact Fractures in Males and Females After 6 Months of Exposure to TZD |
|---|---|
| Description | ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis. |
| Time Frame | From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 and December 31, 2008 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database. |
| Arm/Group Title | TZD Alone | TZD+Spironolactone | TZD+Amiloride | Other |
|---|---|---|---|---|
| Arm/Group Description | Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected. |
| Measure Participants | 21621 | 397 | 43 | 3 |
| Case |
4325
|
105
|
12
|
1
|
| Control |
17296
|
292
|
31
|
2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.42 | |
| Confidence Interval |
(2-Sided) 95% 1.13 to 1.78 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Reference group: TZD alone. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.19 | |
| Confidence Interval |
(2-Sided) 95% 0.93 to 1.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.53 | |
| Confidence Interval |
(2-Sided) 95% 0.78 to 2.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Reference group: TZD alone. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.46 | |
| Confidence Interval |
(2-Sided) 95% 0.74 to 2.89 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.01 | |
| Confidence Interval |
(2-Sided) 95% 0.18 to 22.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Undadjusted Odds Ratio. Reference Group: TZD alone. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.34 | |
| Confidence Interval |
(2-Sided) 95% 0.12 to 15.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
| Title | Number of Low Impact Fractures in Males and Females After 12 Months of Exposure to TZD |
|---|---|
| Description | ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis. |
| Time Frame | From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database. |
| Arm/Group Title | TZD Alone | TZD+Spironolactone | TZD+Amiloride | Other |
|---|---|---|---|---|
| Arm/Group Description | Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolacton, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected. |
| Measure Participants | 13115 | 245 | 28 | 2 |
| Case |
2619
|
64
|
8
|
0
|
| Control |
10496
|
181
|
20
|
2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.41 | |
| Confidence Interval |
(2-Sided) 95% 1.05 to 1.89 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Reference group: TZD alone. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.20 | |
| Confidence Interval |
(2-Sided) 95% 0.88 to 1.65 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.58 | |
| Confidence Interval |
(2-Sided) 95% 0.69 to 3.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Reference group: TZD alone. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.63 | |
| Confidence Interval |
(2-Sided) 95% 0.70 to 3.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
| Title | Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 6 Months of Exposure to TZD |
|---|---|
| Description | ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis. |
| Time Frame | From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database. |
| Arm/Group Title | TZD Alone | TZD+Spironolactone | TZD+Amiloride | Other |
|---|---|---|---|---|
| Arm/Group Description | Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected. |
| Measure Participants | 10778 | 196 | 20 | 3 |
| Case |
2163
|
48
|
2
|
1
|
| Control |
8615
|
148
|
18
|
2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.29 | |
| Confidence Interval |
(2-Sided) 95% 0.92 to 1.79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Reference Group: TZD alone. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% 0.71 to 1.45 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.44 | |
| Confidence Interval |
(2-Sided) 95% 0.10 to 1.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Reference group: TZD alone. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.35 | |
| Confidence Interval |
(2-Sided) 95% 0.08 to 1.54 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.99 | |
| Confidence Interval |
(2-Sided) 95% 0.18 to 21.93 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Reference group: TZD alone. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.05 | |
| Confidence Interval |
(2-Sided) 95% 0.09 to 12.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
| Title | Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 12 Months of Exposure to TZD |
|---|---|
| Description | ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis. |
| Time Frame | From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database. |
| Arm/Group Title | TZD Alone | TZD+Spironolactone | TZD+Amiloride | Other |
|---|---|---|---|---|
| Arm/Group Description | Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected. |
| Measure Participants | 6400 | 123 | 12 | 2 |
| Case |
1285
|
29
|
0
|
0
|
| Control |
5115
|
94
|
12
|
2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.23 | |
| Confidence Interval |
(2-Sided) 95% 0.80 to 1.88 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Reference group: TZD alone. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.62 to 1.57 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates | |
| Title | Number of Hip Fractures Combined in Males and Females After 6 Months of Exposure to TZD |
|---|---|
| Description | ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis. |
| Time Frame | From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database. |
| Arm/Group Title | TZD Alone | TZD+Spironolactone | TZD+Amiloride | Other |
|---|---|---|---|---|
| Arm/Group Description | Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days |
| Measure Participants | 479 | 10 | 0 | 0 |
| Case |
92
|
6
|
||
| Control |
387
|
4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 5.46 | |
| Confidence Interval |
(2-Sided) 95% 1.53 to 19.45 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Reference group: TZD alone. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.19 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 15.86 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
| Title | Number of Hip Fractures Combined in Males and Females After 12 Months of Exposure to TZD |
|---|---|
| Description | ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis. |
| Time Frame | From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database. |
| Arm/Group Title | TZD Alone | TZD+Spironolactone | TZD+Amiloride | Other |
|---|---|---|---|---|
| Arm/Group Description | Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected. | Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days |
| Measure Participants | 226 | 3 | 0 | 0 |
| Case |
44
|
2
|
||
| Control |
182
|
1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 7.26 | |
| Confidence Interval |
(2-Sided) 95% 0.66 to 80.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Reference group: TZD alone. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Spironolactone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.78 | |
| Confidence Interval |
(2-Sided) 95% 0.03 to 96.47 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Adjusted Odds Ratio. Reference group: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosponates. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Small numbers model didn't converge. Reference Group: TZD alone. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, TZD+Amiloride |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TZD Alone, Other |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates. | |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | This is a retrospective study of pre-existing medical record and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible. | |||
| Arm/Group Title | TZD 6-month Cohort | TZD-12 Month Cohort | ||
| Arm/Group Description | The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database. | The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database. | ||
All Cause Mortality |
||||
| TZD 6-month Cohort | TZD-12 Month Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| TZD 6-month Cohort | TZD-12 Month Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| TZD 6-month Cohort | TZD-12 Month Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01055223
Other Study ID Numbers:
- 113332
First Posted:
Jan 25, 2010
Last Update Posted:
May 30, 2017
Last Verified:
May 1, 2017