Clinical trial NCT01332500: Treximet ™ Pharmacy Budget Impact Model Database Validation Study
Official title: Treximet ™ Pharmacy Budget Impact Model Database Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Keywords: Triptans
Migraine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 61737
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject data from a claims database having at least one pharmacy claim for Treximet ™ or an orally administered triptan during the study period.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis
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)
measure: Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
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)
measure: Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
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)
measure: Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis
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)
measure: Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
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)
measure: Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
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)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: