Clinical trial NCT01381523: A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data
Official title: A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Keywords: resource utilization
naproxen sodium
cost and cost analysis
triptan
migraine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted using retrospective health care claims data from insured migraine patients aged 18 to 64. Patients with a pharmacy claim for a combination treatment of sumatriptan and naproxen sodium (SumaRT/Nap) during the index period will be identified. If the SumaRT/Nap prescription is not preceeded by a single-entity triptan pharmacy claim in the 6-month, pre-index period, that patient will be included in the triptan-naive cohort. Propensity score matching will be used to identify migraine patients with new single-entity triptan claims as a comparator group. Patients with a pharmacy claim for a single-entity triptan in the 6-month, pre-index period and a pharmacy claim for SumaRT/Nap will be included in the triptan switch cohort. Propensity score matching will be used to identify patients with similar characteristics who switch to a new triptan as a comparator group.

Brief 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.


Eligibility 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

Primary outcomes:
measure: Mean number of tablets dispensed
timeFrame: In the 6 months immediately preceding the index date and during the 6-month follow-up period that begins at the index date
Secondary outcomes:
measure: Mean and total migraine-related pharmacy costs
timeFrame: During the 6-month follow-up period that begins at the index date
measure: Mean and total migraine-related medical costs
timeFrame: During the 6-month follow-up period that begins at the index date
measure: Mean numbers of migraine-related medical visits
timeFrame: During the 6-month follow-up period that begins at the index date
measure: Mean numbers and costs (adjusted to 2009 US dollars) of all-cause resource use measures
timeFrame: During the 6-month follow-up period that begins at the index date
measure: Presence of preventive medications
timeFrame: During the 6-month follow-up period that begins at the index date
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: