Treximet ™ Pharmacy Budget Impact Model Database Validation Study

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Migraine Disorders

Treatments: Drug: other oral triptans; Drug: Sumatriptan/Naproxen combination

Study type: Observational

Funder types: Industry

Identifiers

NCT01332500

111208

Details and patient eligibility

About

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.

Enrollment: 61,737 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

61,737 participants in 1 patient group

adult migraineurs with/without aura

Description:

Adult migraine patients \>18-65 years who have initiated treatment for migraine with Treximet ™ or other orally administered triptan.

Treatment:

Drug: Sumatriptan/Naproxen combination

Drug: other oral triptans