Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials.
OBJECTIVE
To evaluate the efficacy and tolerability of sumatriptan-naproxen during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea.


METHODS
Two replicate randomized, multicenter, double-blind, placebo-controlled, trials of adults with menstrual migraine and dysmenorrhea were conducted. Participants treated their menstrual migraine attack during the mild pain phase (within 1 hour of onset) with sumatriptan 85 mg and naproxen sodium 500 mg in a single fixed-dose formulation (sumatriptan-naproxen) or placebo. The primary endpoint was 2-hour pain-free response.


RESULTS
Sumatriptan-naproxen was statistically superior to placebo in both studies (n=311, Study 1; n=310, Study 2) for 2-hour and, 2- to 24-hour sustained pain-free response, use of headache and menstrual rescue medications, and several nonpain menstrual symptom categories. Two-hour pain-free rates were Study 1, 42% compared with 23%, and Study 2, 52% compared with 22%, P<.001. Two- to 24-hour sustained pain-free rates were Study 1, 29% compared with 18%, P=.022; Study 2, 38% compared with 10%, P<.001. Headache and menstrual medication rates were Study 1, 37% compared with 53%, P=.005; Study 2, 31% compared with 69%, P<.001. Women treated with sumatriptan-naproxen continued to be pain free through 48 hours compared with placebo: Study 1, 26% compared with 17%, P=.040; Study 2, 28% compared with 8%, P<.001. No serious adverse events were reported in either study; nausea and dizziness were the most frequently reported adverse events.


CONCLUSIONS
Sumatriptan-naproxen provided an effective pain-free response at 2 hours, which was maintained up to 48 hours in menstrual migraineurs with dysmenorrhea. Sumatriptan-naproxen was well-tolerated and resulted in decreased rescue medication use and relief of nonpainful menstrual symptoms.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00329459 and NCT00329355


METHODS
I.
Mannix
Lisa K
LK
From the Headache Associates, West Chester, Ohio; General Internal Medicine, University of Cincinnati Medical Center, Cincinnati, Ohio; Headache Care Center, Springfield, Missouri; Diamond Headache Clinic, Chicago, Illinois; and GlaxoSmithKline, Research Triangle Park, North Carolina.
Martin
Vincent T
VT
Cady
Roger K
RK
Diamond
Merle L
ML
Lener
Shelly E
SE
White
Jonathan D
JD
Derosier
Frederick J
FJ
McDonald
Susan A
SA
D000284:Administration, Oral; D000328:Adult; D004311:Double-Blind Method; D004338:Drug Combinations; D004412:Dysmenorrhea / Q000150:complications* / Q000188:drug therapy; D005260:Female; D006801:Humans; D008881:Migraine Disorders / Q000188:drug therapy*; D009288:Naproxen / Q000008:administration & dosage*; D018170:Sumatriptan / Q000008:administration & dosage*
D004338:Drug Combinations; D009288:Naproxen; D018170:Sumatriptan