Multimechanistic (sumatriptan-naproxen) early intervention for the acute treatment of migraine.

Abstract

BACKGROUND:

Research suggests treating a migraine at the first sign of pain increases the likelihood of the best clinical outcome.

OBJECTIVE:

To investigate the efficacy and tolerability of a fixed-dose, single-tablet formulation of sumatriptan 85 mg, formulated with RT Technology, and naproxen sodium 500 mg (sumatriptan/naproxen) as early intervention acute therapy for migraine.

METHODS:

Patients (aged 18 to 65 years) with International Headache Society-defined migraine with or without aura were enrolled in one of two identically designed, randomized, double-blind, parallel group, placebo-controlled studies. Patients treated a single migraine within 1 hour of onset of migraine head pain and while the pain was mild with either sumatriptan/naproxen or placebo. The primary efficacy measure was the percentage of patients who became pain-free 2 hours postdose.

RESULTS:

Intent-to-treat analyses consisted of 576 and 535 migraineurs. At 2 hours, 52% and 51% of sumatriptan/naproxen-treated patients were pain free, as compared to 17% and 15% of placebo-treated patients (p < 0.001). Significant pain-free responses in favor of sumatriptan/naproxen were demonstrated as early as 30 minutes, maintained at 1 hour, and sustained from 2 to 24 hours. At 2 and 4 hours, sumatriptan/naproxen provided significantly lower rates of traditional migraine-associated symptoms (nausea, photophobia, and phonophobia) and nontraditional migraine-associated symptoms (neck pain/discomfort and sinus pain/pressure). The most commonly reported adverse events were nausea (< or =4%) and dizziness (< or =2%).

CONCLUSION:

The fixed-dose single-tablet formulation of sumatriptan/naproxen was effective and well tolerated in an early intervention paradigm for the acute treatment of migraine, including traditional and nontraditional symptoms.

• Authors: S D Silberstein, L K Mannix, J Goldstein, J R Couch, S C Byrd, M H Ames, S A McDonald, S E Lener, Cynthia Toso
• Journal: Neurology (Neurology) Vol. 71 Issue 2 Pg. 114-21 (Jul 08 2008) ISSN: 1526-632X [Electronic] United States
• PMID: 18606965 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Naproxen
• Sumatriptan

Topics

• Adult
• Aged
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Naproxen (administration & dosage, adverse effects)
• Nausea (chemically induced)
• Sumatriptan (administration & dosage, adverse effects)
• Treatment Outcome