Get access

Consistency of Return to Normal Function, Productivity, and Satisfaction Following Migraine Attacks Treated With Sumatriptan/Naproxen Sodium Combination

Authors


  • Conflict of Interest: GlaxoSmithKline was the study sponsor and funded the research described in this manuscript. Pozen, Inc. was the IND sponsor of the research described. Medical writing was conducted by Reese Associates Consulting, LLC, with financial support from GlaxoSmithKline, and by Christopher F. Bell, an employee of, and stakeholder in, GlaxoSmithKline. Jonathan White is an employee of, and stakeholder in, GlaxoSmithKline. Andrew Nelsen was employed by GlaxoSmithKline at the time of the conduct and analysis of the study, but is now employed by United Therapeutics. M. Chris Runken was employed by GlaxoSmithKline at the time of the conduct and analysis of the study, but is now employed by Astellas Pharma. Stephen Landy and Roger Cady were investigators in the conduct of this study and received funding from GlaxoSmithKline. All named authors also reviewed and approved this manuscript.

Address all correspondence to C.F. Bell, GlaxoSmithKline, Five Moore Drive, B. 3131, Research Triangle Park, NC 27709, USA, email: christopher.f.bell@gsk.com

Abstract

Objectives

To assess the consistency of improved functioning, productivity, and medication satisfaction in migraines treated with a single tablet of sumatriptan 85 mg/naproxen sodium 500 mg (S/NS) using an early intervention approach.

Methods

Two randomized, double-blind, placebo-controlled, 4-period crossover, multi-attack, multi-center, outpatient studies of moderate to severe adult migraineurs were conducted to compare S/NS with placebo. Participants recorded outcome assessments in a diary during the 24 hours following study medication. Analyses were conducted on the intent-to-treat population who treated at least 1 attack. Statistical significance between treatment groups used analysis of variance repeated measures models and the intent-to-treat population. There were no corrections for multiplicity.

Results

Almost half (48.5%) of migraineurs treated with S/NS returned to normal functioning at 2 hours and 73.3% at 4 hours postdose, compared with 28.7% (2 hours) and 43.3% (4 hours) of placebo-treated attacks. Total productivity loss over the 24 hours postdose was significantly reduced following S/NS treatment (2.5 hours on average) compared with placebo (4.0 hours). Sumatriptan/naproxen treatment resulted in significantly higher medication satisfaction scores on the efficacy, functionality, and total efficacy subscales compared with placebo in all attacks in both studies. Sumatriptan/naproxen treatment also provided significantly greater ease of use in 7 of the 8 attacks. Although tolerability was high in both treatment groups (over 90%), the placebo group was significantly less bothered by side effects in 6 of 8 attacks.

Conclusion

Results from these 2 randomized, double-blind, placebo-controlled, multi-attack, crossover studies demonstrated the rapid and consistent restoration of patients' functioning, the consistent reduction in productivity loss, and high satisfaction ratings from patients treating multiple migraine attacks with S/NS using an early intervention approach.

Ancillary