Trial Outcomes & Findings for Treximet ™ Pharmacy Budget Impact Model Database Validation Study (NCT NCT01332500)
NCT ID: NCT01332500
Last Updated: 2017-05-30
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
61737 participants
Primary outcome timeframe
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)
Results posted on
2017-05-30
Participant Flow
Participant milestones
| Measure |
Naïve - Sumatriptan/Naproxen Sodium
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.
|
Naïve - 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 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.
|
Switch - Sumatriptan/Naproxen Sodium
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.
|
Switch - 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) 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13257
|
39771
|
2903
|
5806
|
|
Overall Study
COMPLETED
|
13257
|
39771
|
2903
|
5806
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treximet ™ Pharmacy Budget Impact Model Database Validation Study
Baseline characteristics by cohort
| Measure |
Naïve - Sumatriptan/Naproxen Sodium
n=13257 Participants
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.
|
Naïve - Oral Triptan
n=39771 Participants
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.
|
Switch - Sumatriptan/Naproxen Sodium
n=2903 Participants
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.
|
Switch - Oral Triptan
n=5806 Participants
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
n=61737 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-30 years old
|
2889 Participants
n=5 Participants
|
8867 Participants
n=7 Participants
|
464 Participants
n=5 Participants
|
1026 Participants
n=4 Participants
|
13246 Participants
n=21 Participants
|
|
Age, Customized
31-40 years old
|
3425 Participants
n=5 Participants
|
10172 Participants
n=7 Participants
|
669 Participants
n=5 Participants
|
1251 Participants
n=4 Participants
|
15517 Participants
n=21 Participants
|
|
Age, Customized
41-50 years old
|
3700 Participants
n=5 Participants
|
10887 Participants
n=7 Participants
|
943 Participants
n=5 Participants
|
1763 Participants
n=4 Participants
|
17293 Participants
n=21 Participants
|
|
Age, Customized
51-60 years old
|
2315 Participants
n=5 Participants
|
6993 Participants
n=7 Participants
|
610 Participants
n=5 Participants
|
1263 Participants
n=4 Participants
|
11181 Participants
n=21 Participants
|
|
Age, Customized
61-70 years old
|
758 Participants
n=5 Participants
|
2368 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
428 Participants
n=4 Participants
|
3745 Participants
n=21 Participants
|
|
Age, Customized
>70 years old
|
170 Participants
n=5 Participants
|
484 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
755 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
11108 Participants
n=5 Participants
|
33371 Participants
n=7 Participants
|
2525 Participants
n=5 Participants
|
5078 Participants
n=4 Participants
|
52082 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2149 Participants
n=5 Participants
|
6400 Participants
n=7 Participants
|
378 Participants
n=5 Participants
|
728 Participants
n=4 Participants
|
9655 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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).
Outcome measures
| Measure |
Naïve - Sumatriptan/Naproxen Sodium
n=13257 Participants
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.
|
Naïve - Oral Triptan
n=39771 Participants
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.
|
|---|---|---|
|
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis
Triptans
|
17.7 tablets per participant
Standard Deviation 16.3
|
18.4 tablets per participant
Standard Deviation 18.2
|
|
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis
Non-steroidal anti-inflammatory drugs
|
19.2 tablets per participant
Standard Deviation 57.1
|
21.5 tablets per participant
Standard Deviation 64.9
|
|
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis
Opioids
|
75.8 tablets per participant
Standard Deviation 219.0
|
80.1 tablets per participant
Standard Deviation 235.8
|
|
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis
Ergots
|
0.1 tablets per participant
Standard Deviation 3.6
|
0.1 tablets per participant
Standard Deviation 2.4
|
|
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis
Other
|
1.5 tablets per participant
Standard Deviation 17.0
|
1.4 tablets per participant
Standard Deviation 13.9
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Naïve - Sumatriptan/Naproxen Sodium
n=13257 Participants
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.
|
Naïve - Oral Triptan
n=39771 Participants
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.
|
|---|---|---|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Triptans
|
284 United States dollars
Standard Deviation 366.1
|
333 United States dollars
Standard Deviation 393.7
|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Non-steroidal anti-inflammatory drugs
|
9 United States dollars
Standard Deviation 62.3
|
9 United States dollars
Standard Deviation 62.5
|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Opioids
|
38 United States dollars
Standard Deviation 609.7
|
43 United States dollars
Standard Deviation 477.6
|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Ergots
|
2 United States dollars
Standard Deviation 33.1
|
2 United States dollars
Standard Deviation 51.2
|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Other
|
0 United States dollars
Standard Deviation 5.1
|
0 United States dollars
Standard Deviation 4.8
|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Total
|
332 United States dollars
Standard Deviation 732.1
|
387 United States dollars
Standard Deviation 645.4
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Naïve - Sumatriptan/Naproxen Sodium
n=13257 Participants
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.
|
Naïve - Oral Triptan
n=39771 Participants
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.
|
|---|---|---|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Triptans
|
349 United States dollars
Standard Deviation 396.4
|
397 United States dollars
Standard Deviation 418.9
|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Non-steroidal anti-inflammatory drugs
|
11 United States dollars
Standard Deviation 69.8
|
12 United States dollars
Standard Deviation 72.5
|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Opioids
|
49 United States dollars
Standard Deviation 621.0
|
54 United States dollars
Standard Deviation 509.5
|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Ergots
|
2 United States dollars
Standard Deviation 36.6
|
2 United States dollars
Standard Deviation 55.5
|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Other
|
1 United States dollars
Standard Deviation 8.6
|
1 United States dollars
Standard Deviation 7.2
|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Total
|
412 United States dollars
Standard Deviation 757.7
|
466 United States dollars
Standard Deviation 687.7
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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).
Outcome measures
| Measure |
Naïve - Sumatriptan/Naproxen Sodium
n=2903 Participants
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.
|
Naïve - Oral Triptan
n=5806 Participants
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.
|
|---|---|---|
|
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis
Triptans
|
24.4 tablets per participant
Standard Deviation 20.7
|
24.4 tablets per participant
Standard Deviation 20.2
|
|
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis
Non-steroidal anti-inflammatory drugs
|
20.9 tablets per participant
Standard Deviation 62.5
|
22.9 tablets per participant
Standard Deviation 70.9
|
|
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis
Opioids
|
88.4 tablets per participant
Standard Deviation 254.7
|
87.4 tablets per participant
Standard Deviation 255.7
|
|
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis
Ergots
|
0.0 tablets per participant
Standard Deviation 1.6
|
0.1 tablets per participant
Standard Deviation 3.7
|
|
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis
Other
|
1.4 tablets per participant
Standard Deviation 14.9
|
1.3 tablets per participant
Standard Deviation 12.1
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Naïve - Sumatriptan/Naproxen Sodium
n=2903 Participants
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.
|
Naïve - Oral Triptan
n=5806 Participants
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.
|
|---|---|---|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Triptans
|
375 United States dollars
Standard Deviation 374.5
|
425 United States dollars
Standard Deviation 413.3
|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Non-steroidal anti-inflammatory drugs
|
8 United States dollars
Standard Deviation 52.5
|
10 United States dollars
Standard Deviation 67.2
|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Opioids
|
47 United States dollars
Standard Deviation 317.8
|
51 United States dollars
Standard Deviation 522.9
|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Ergots
|
3 United States dollars
Standard Deviation 48.9
|
3 United States dollars
Standard Deviation 50.1
|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Other
|
0 United States dollars
Standard Deviation 6.7
|
0 United States dollars
Standard Deviation 3.9
|
|
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Total
|
433 United States dollars
Standard Deviation 507.4
|
490 United States dollars
Standard Deviation 695.8
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Naïve - Sumatriptan/Naproxen Sodium
n=2903 Participants
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.
|
Naïve - Oral Triptan
n=5806 Participants
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.
|
|---|---|---|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Triptans
|
462 United States dollars
Standard Deviation 413.3
|
496 United States dollars
Standard Deviation 439.9
|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Non-steroidal anti-inflammatory drugs
|
12 United States dollars
Standard Deviation 62.3
|
13 United States dollars
Standard Deviation 76.7
|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Opioids
|
61 United States dollars
Standard Deviation 360.2
|
62 United States dollars
Standard Deviation 547.4
|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Ergots
|
3 United States dollars
Standard Deviation 51.9
|
4 United States dollars
Standard Deviation 54.4
|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Other
|
1 United States dollars
Standard Deviation 8.5
|
1 United States dollars
Standard Deviation 6.1
|
|
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Total
|
537 United States dollars
Standard Deviation 564.2
|
576 United States dollars
Standard Deviation 736.2
|
Adverse Events
Naïve - Sumatriptan/Naproxen Sodium
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Naïve - Oral Triptan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Switch - Sumatriptan/Naproxen Sodium
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Switch - Oral Triptan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER