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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381523
• Other study ID #: 113913
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: February 21, 2013
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap)
Patients with new pharmacy claims for SumaRT/Nap with separate analyses for patients with at least one triptan pharmacy claim in the 6-month, pre-index period and those who are triptan-naive based on 6 months of data
• Single-entity oral triptans
Patients are propensity score matched to patients in the SumaRT/Nap groups and analyzed separately if patient has a pharmacy claim for a different type of triptan in the previous 6 months or is triptan treatment naive. Triptans included almotriptan, naratriptan, rizatriptan, eletriptan, zolmitriptan, frovatriptan, sumatriptan.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of tablets dispensed	The mean number of tables dispensed as measured by pharmacy claims for prescription medications including triptans, NSAIDs, and opioids	In the 6 months immediately preceding the index date and during the 6-month follow-up period that begins at the index date	No
Secondary	Mean and total migraine-related pharmacy costs	All costs will be adjusted to 2009 US dollars. Results will include costs to the health plan and costs to the patients. Costs will be reported for triptans, migraine prophylaxis, NSAIDs, opioids, and antiemetics	During the 6-month follow-up period that begins at the index date	No
Secondary	Mean and total migraine-related medical costs	All costs will be adjusted to 2009 US dollars. Costs will include those for hospitizations, emergency department visits, physician visits, other outpatient visits, and other medical costs	During the 6-month follow-up period that begins at the index date	No
Secondary	Mean numbers of migraine-related medical visits	Results will include hospitalizations, visits to the emergency department, physician visits, and other outpatient visits	During the 6-month follow-up period that begins at the index date	No
Secondary	Mean numbers and costs (adjusted to 2009 US dollars) of all-cause resource use measures	Results will include all-cause hospitalizations, emergency department visits, physician visits, and outpatient visits. Costs reported by total, pharmacy and medical	During the 6-month follow-up period that begins at the index date	No
Secondary	Presence of preventive medications	Pharmacy claims for migraine prophylactic medications including tricyclic antidepressants, calcium channel blockers, beta blockers, mirtazapine, venlafaxine, valproic acid, gabapentin, tiagabine, topiramate, carbamazapine, and botulinium toxin	During the 6-month follow-up period that begins at the index date	No