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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine Disorders

Intervention: Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap) (Drug); Single-entity oral triptans (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

The goal of this study is to measure medical resource utilization, treatment patterns, and costs for 1.) triptan-na´ve 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-na├»ve 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 na├»ve 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 Details

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

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Mean number of tablets dispensed

Secondary outcome:

Mean and total migraine-related pharmacy costs

Mean and total migraine-related medical costs

Mean numbers of migraine-related medical visits

Mean numbers and costs (adjusted to 2009 US dollars) of all-cause resource use measures

Presence of preventive medications

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients aged 18 to 64 years

- Patients with continuous health plan eligibility during the 6-month pre-index period

and follow-up period

- Patients in the triptan switch analysis must have at least one pharmacy claim for an

oral triptan in the 6 month, pre-index period Exclusion Criteria:

- Patients with a pharmacy claim for a nasal triptan at any time during the study

period

- Patients with pharmacy claims for more than one type of oral triptan on the index

date

- Patients in the single-entity oral triptan study groups who have a pharmacy claim for

SumaRT/Nap during the 6-month follow-up period

Locations and Contacts

Additional Information

Starting date: November 2010
Last updated: February 21, 2013

Page last updated: August 23, 2015

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