Treximet ™ Pharmacy Budget Impact Model Database Validation Study
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01332500
Collaborator
(none)
61,737
8
Study Details
Study Description
Brief Summary
The purpose of this retrospective claims database study was to compare the change in migraine-related prescription (i.e. NSAIDs, Opioids, Ergots) utilization among migraine suffers following initiation of Treximet ™ (sumatriptan/naproxen) compared with subjects initiating treatment with other orally available triptans. The study was used to validate the migraine-related prescription utilization patterns predicted by the Treximet ™ Budget Impact Model.
The SourceLx dataset from the family of Wolters Kluwer databases was used for this analysis. The database contains 30% of prescription claims filled in the United States (US), approximately 160 million patient lives. The data has broad representative coverage at both the geographic and payment levels.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
61737 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Treximet ™ Pharmacy Budget Impact Model Database Validation Study
Study Start Date
:
Jul 1, 2009
Actual Primary Completion Date
:
Mar 1, 2010
Actual Study Completion Date
:
Mar 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| adult migraineurs with/without aura Adult migraine patients >18-65 years who have initiated treatment for migraine with Treximet ™ or other orally administered triptan. |
Drug: Sumatriptan/Naproxen combination
Sumatriptan and Naproxen Sodium
Other Names:
Drug: other oral triptans
almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
|
Outcome Measures
Primary Outcome Measures
- Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis [6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)]
The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. "Other" represents acetaminophen (APAP)/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the "quantity dispensed field" in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans).
- Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis [6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)]
Health plan cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.
- Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis [6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)]
Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.
- Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis [6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)]
The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. "Other" represents APAP/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the "quantity dispensed field" in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans).
- Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis [6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)]
Health Pan Cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.
- Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis [6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)]
Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). .Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.
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 prescription claim for either Treximet ™ or orally administered triptan
-
at least 18 years of age at index Rx date
-
at least one prescription claim for any medication in the pre- and post-index period (proxy for continuous enrollment)
Exclusion Criteria:
-
Subjects receiving nasal sumatriptan at any time
-
Subjects over 65 years of age
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:
NCT01332500
Other Study ID Numbers:
- 111208
First Posted:
Apr 11, 2011
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 | Naïve - Sumatriptan/Naproxen Sodium | Naïve - Oral Triptan | Switch - Sumatriptan/Naproxen Sodium | Switch - Oral Triptan |
|---|---|---|---|---|
| Arm/Group Description | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. |
| Period Title: Overall Study | ||||
| STARTED | 13257 | 39771 | 2903 | 5806 |
| COMPLETED | 13257 | 39771 | 2903 | 5806 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Naïve - Sumatriptan/Naproxen Sodium | Naïve - Oral Triptan | Switch - Sumatriptan/Naproxen Sodium | Switch - Oral Triptan | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Total of all reporting groups |
| Overall Participants | 13257 | 39771 | 2903 | 5806 | 61737 |
| Age, Customized (Number) [Number] | |||||
| 18-30 years old |
2889
21.8%
|
8867
22.3%
|
464
16%
|
1026
17.7%
|
13246
21.5%
|
| 31-40 years old |
3425
25.8%
|
10172
25.6%
|
669
23%
|
1251
21.5%
|
15517
25.1%
|
| 41-50 years old |
3700
27.9%
|
10887
27.4%
|
943
32.5%
|
1763
30.4%
|
17293
28%
|
| 51-60 years old |
2315
17.5%
|
6993
17.6%
|
610
21%
|
1263
21.8%
|
11181
18.1%
|
| 61-70 years old |
758
5.7%
|
2368
6%
|
191
6.6%
|
428
7.4%
|
3745
6.1%
|
| >70 years old |
170
1.3%
|
484
1.2%
|
26
0.9%
|
75
1.3%
|
755
1.2%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
11108
83.8%
|
33371
83.9%
|
2525
87%
|
5078
87.5%
|
52082
84.4%
|
| Male |
2149
16.2%
|
6400
16.1%
|
378
13%
|
728
12.5%
|
9655
15.6%
|
Outcome Measures
| Title | Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis |
|---|---|
| Description | The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. "Other" represents acetaminophen (APAP)/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the "quantity dispensed field" in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans). |
| Time Frame | 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives. |
| Arm/Group Title | Naïve - Sumatriptan/Naproxen Sodium | Naïve - Oral Triptan |
|---|---|---|
| Arm/Group Description | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. |
| Measure Participants | 13257 | 39771 |
| Triptans |
17.7
(16.3)
|
18.4
(18.2)
|
| Non-steroidal anti-inflammatory drugs |
19.2
(57.1)
|
21.5
(64.9)
|
| Opioids |
75.8
(219.0)
|
80.1
(235.8)
|
| Ergots |
0.1
(3.6)
|
0.1
(2.4)
|
| Other |
1.5
(17.0)
|
1.4
(13.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Triptan tablets | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Non-steroidal anti-inflammatory drug tablets | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | Opioid tablets | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.336 |
| Comments | Ergot tablets | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.162 |
| Comments | Other tablets | |
| Method | paired t-test 2-sided | |
| Comments | ||
| Title | Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis |
|---|---|
| Description | Health plan cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories. |
| Time Frame | 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives. |
| Arm/Group Title | Naïve - Sumatriptan/Naproxen Sodium | Naïve - Oral Triptan |
|---|---|---|
| Arm/Group Description | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. |
| Measure Participants | 13257 | 39771 |
| Triptans |
284
(366.1)
|
333
(393.7)
|
| Non-steroidal anti-inflammatory drugs |
9
(62.3)
|
9
(62.5)
|
| Opioids |
38
(609.7)
|
43
(477.6)
|
| Ergots |
2
(33.1)
|
2
(51.2)
|
| Other |
0
(5.1)
|
0
(4.8)
|
| Total |
332
(732.1)
|
387
(645.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Triptan health plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.349 |
| Comments | Non-steroidal anti-inflammatory drug health plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.208 |
| Comments | Opioid health plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.239 |
| Comments | Ergot health plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.583 |
| Comments | Other health plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Total heath plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
| Title | Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis |
|---|---|
| Description | Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories. |
| Time Frame | 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives. |
| Arm/Group Title | Naïve - Sumatriptan/Naproxen Sodium | Naïve - Oral Triptan |
|---|---|---|
| Arm/Group Description | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. |
| Measure Participants | 13257 | 39771 |
| Triptans |
349
(396.4)
|
397
(418.9)
|
| Non-steroidal anti-inflammatory drugs |
11
(69.8)
|
12
(72.5)
|
| Opioids |
49
(621.0)
|
54
(509.5)
|
| Ergots |
2
(36.6)
|
2
(55.5)
|
| Other |
1
(8.6)
|
1
(7.2)
|
| Total |
412
(757.7)
|
466
(687.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Triptan health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.177 |
| Comments | Non-steroidal, anti-inflammatory drug health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.173 |
| Comments | Opioid health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.191 |
| Comments | Ergot health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.254 |
| Comments | Other health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Total health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
| Title | Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis |
|---|---|
| Description | The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. "Other" represents APAP/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the "quantity dispensed field" in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans). |
| Time Frame | 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives. |
| Arm/Group Title | Switch - Sumatriptan/Naproxen Sodium | Switch - Oral Triptan |
|---|---|---|
| Arm/Group Description | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. |
| Measure Participants | 2903 | 5806 |
| Triptans |
24.4
(20.7)
|
24.4
(20.2)
|
| Non-steroidal anti-inflammatory drugs |
20.9
(62.5)
|
22.9
(70.9)
|
| Opioids |
88.4
(254.7)
|
87.4
(255.7)
|
| Ergots |
0.0
(1.6)
|
0.1
(3.7)
|
| Other |
1.4
(14.9)
|
1.3
(12.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.866 |
| Comments | Triptan tablets | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.094 |
| Comments | Non-steroidal anti-inflammatory drug tablets | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.832 |
| Comments | Opioid tablets | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.392 |
| Comments | Ergot tablets | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.752 |
| Comments | Other tablets | |
| Method | paired t-test 2-sided | |
| Comments | ||
| Title | Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis |
|---|---|
| Description | Health Pan Cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories. |
| Time Frame | 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives. |
| Arm/Group Title | Switch - Sumatriptan/Naproxen Sodium | Switch - Oral Triptan |
|---|---|---|
| Arm/Group Description | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. |
| Measure Participants | 2903 | 5806 |
| Triptans |
375
(374.5)
|
425
(413.3)
|
| Non-steroidal anti-inflammatory drugs |
8
(52.5)
|
10
(67.2)
|
| Opioids |
47
(317.8)
|
51
(522.9)
|
| Ergots |
3
(48.9)
|
3
(50.1)
|
| Other |
0
(6.7)
|
0
(3.9)
|
| Total |
433
(507.4)
|
490
(695.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Triptan health plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.054 |
| Comments | Non-steroidal anti-inflammatory drug health plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.590 |
| Comments | Opioid health plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.382 |
| Comments | Ergot health plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.343 |
| Comments | Other health plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Total health plan costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
| Title | Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis |
|---|---|
| Description | Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). .Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories. |
| Time Frame | 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives. |
| Arm/Group Title | Switch - Sumatriptan/Naproxen Sodium | Switch - Oral Triptan |
|---|---|---|
| Arm/Group Description | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. |
| Measure Participants | 2903 | 5806 |
| Triptans |
462
(413.3)
|
496
(439.9)
|
| Non-steroidal anti-inflammatory drugs |
12
(62.3)
|
13
(76.7)
|
| Opioids |
61
(360.2)
|
62
(547.4)
|
| Ergots |
3
(51.9)
|
4
(54.4)
|
| Other |
1
(8.5)
|
1
(6.1)
|
| Total |
537
(564.2)
|
576
(736.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Triptan health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.146 |
| Comments | Non-steroidal anti-inflammatory drug health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.826 |
| Comments | Opioid health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.354 |
| Comments | Ergot health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.514 |
| Comments | Other health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Total health plus copay costs | |
| Method | paired t-test 2-sided | |
| Comments | ||
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | This study was a retrospective, observational cohort study with the primary purpose of assessing migraine-specific pharmacy utilization and costs associated with initiating/switching to sumatriptan/naproxen sodium compared to other oral triptans. Therefore, adverse event information was not captured. | |||||||
| Arm/Group Title | Naïve - Sumatriptan/Naproxen Sodium | Naïve - Oral Triptan | Switch - Sumatriptan/Naproxen Sodium | Switch - Oral Triptan | ||||
| Arm/Group Description | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. | ||||
All Cause Mortality |
||||||||
| Naïve - Sumatriptan/Naproxen Sodium | Naïve - Oral Triptan | Switch - Sumatriptan/Naproxen Sodium | Switch - Oral Triptan | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Naïve - Sumatriptan/Naproxen Sodium | Naïve - Oral Triptan | Switch - Sumatriptan/Naproxen Sodium | Switch - Oral Triptan | |||||
| 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) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Naïve - Sumatriptan/Naproxen Sodium | Naïve - Oral Triptan | Switch - Sumatriptan/Naproxen Sodium | Switch - Oral Triptan | |||||
| 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) | ||||
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:
NCT01332500
Other Study ID Numbers:
- 111208
First Posted:
Apr 11, 2011
Last Update Posted:
May 30, 2017
Last Verified:
May 1, 2017