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


CONCLUSIONS
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.
Silberstein
S D
SD
Jefferson Headache Center, 111 South 11th Street, Suite 8130, Philadelphia, PA 19107, USA. stephen.silberstein@jefferson.edu
Mannix
L K
LK
Goldstein
J
J
Couch
J R
JR
Byrd
S C
SC
Ames
M H
MH
McDonald
S A
SA
Lener
S E
SE
Toso
Cynthia
C
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D009288:Naproxen / Q000008:administration & dosage* / Q000009:adverse effects; D009325:Nausea / Q000139:chemically induced; D018170:Sumatriptan / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D009288:Naproxen; D018170:Sumatriptan