A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data

Migraine Disorders Clinical Trial

Official title: A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data

Status Completed

Clinical Trial Summary

The goal of this study is to measure medical resource utilization, treatment patterns, and costs for 1.) triptan-naïve patients with new pharmacy claims for a combination treatment of sumatriptan and naproxen sodium (SumaRT/Nap) or single-entity triptan and 2.) patients who are switched from one triptan to either SumaRT/Nap or a different single-entity triptan. The analysis will compare the mean number of prescription tablets used (including triptans, NSAIDs, opioids, and ergots) and migraine-specific medical resource utilization/costs and pharmacy costs incurred by health plan members who switched to SumaRT/Nap from a single-entity triptan. The null hypothesis for the triptan-naïve analysis is that no difference will be observed between resource utilization and costs incurred by patients treated with SumaRT/Nap and those treated with a single-entity triptan. The test hypothesis is that one group will incur significantly fewer costs and/or significantly lower health care utilization. For the triptan switch analysis, the null hypothesis is that no difference will be observed in the costs or health care utilization between triptan patients who are switched to SumaRT/Nap compared with those switched to a new triptan. The test hypothesis is that one treatment group will experience significantly lower costs and/or lower health care utilization.

The source of data for this analysis is the Lifelink Health Plan Claims Database (owned by IMS Health, Inc). This claims database includes more than 60 million covered lives. In addition to inpatient and outpatient records, this database includes standard and mail-order pharmacy claims with paid and charged amounts and dates of service.

Data from July 1, 2008 to December 31, 2009 (study period) will be used to conduct these retrospective analyses. Patients with at least one pharmacy claim for SumaRT/Nap between January 1, 2009 and June 30, 2009 (enrollment period) will be identified. The date of the first SumaRT/Nap pharmacy claim will be the index date for those patients. Each patient will be propensity score matched with an oral triptan patient based on the following pre-index covariates: age; gender; payer; geographic region; average monthly number of tablets of triptans, NSAIDs, and opioids; and average number of hospitalizations, emergency department visits, and physician visits in the month immediately preceding the index date as well as the mean number of hospitalizations, emergency department visits, and physician visits in the 5-month pre-index period. SumaRT/Nap patients and their single-entity matched controls who had no pharmacy claims for triptans prior to the index date will be analyzed in the triptan naïve group, and the SumaRT/Nap patients and their single-entity matched controls who switched to a new triptan will be analyzed in the switch analysis.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Migraine Disorders

• NCT number: NCT01381523
• Study type: Observational
• Source: GlaxoSmithKline
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Completion date: June 2011