Rofecoxib in the acute treatment of migraine: a randomized controlled clinical trial.
OBJECTIVE
To investigate the efficacy, tolerability, and safety of rofecoxib and ibuprofen for acute migraine treatment.


BACKGROUND
Rofecoxib was effective and well tolerated in a previous study of treatment of a single migraine attack. We sought to replicate these findings for a single attack and also study the clinical profile of rofecoxib in the acute treatment of multiple migraine attacks. Ibuprofen was included as a reference nonselective NSAID.


METHODS
Adult migraineurs (n = 783) treated one migraine attack with either rofecoxib (25 or 50 mg), ibuprofen 400 mg, or placebo in a randomized, double-blind study. Patients could elect to enroll in a 3-month double-blind extension phase.


RESULTS
In the single-attack phase, headache relief at 2 hours postdose was reported by 59.4%, 62.2%, and 57.7% of patients who took rofecoxib 25 mg, rofecoxib 50 mg, and ibuprofen 400 mg, respectively, versus 30.5% for placebo (all P < .001 vs placebo). The active drugs were statistically superior to placebo on a variety of additional measures. In the extension phase, the mean percentage of patients' attacks with headache relief at 2 hours postdose was 61.8% for rofecoxib 25 mg, 65.4% for rofecoxib 50 mg, and 59.3% for ibuprofen 400 mg. The mean percentage of patients' attacks with 24-hour sustained headache relief was greater for rofecoxib 50 mg (52.0%) than for rofecoxib 25 mg (47.8%, P < .050) or ibuprofen (39.0%, P < .010). In the single-attack phase, the adverse event rate was higher for rofecoxib 50 mg (37.8%) than placebo (27.8%, P < .050); rates were similar to placebo for rofecoxib 25 mg (32.0%, n.s.) and ibuprofen 400 mg (28.1%, n.s.). In the extension phase, treatment groups had similar adverse event rates.


CONCLUSIONS
Rofecoxib 25 and 50 mg and ibuprofen 400 mg were effective and generally well tolerated in the acute treatment of migraine.
Michigan Head Pain & Neurological Institute, Ann Arbor, USA.
Joel
J
Saper
Carl
C
Dahlof
Yuen
Y
So
Peer
P
Tfelt-Hansen
William
W
Malbecq
Thomas
T
Loeys
Eleathea
E
Barraclough
Meghan
M
Klipfel
Christopher
C
Lines
Hester
H
Visser
Scott
S
Reines
Eric
E
Yuen
D000208:Acute Disease; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004244:Dizziness / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D009325:Nausea / Q000139:chemically induced; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use*; D013450:Sulfones / Q000627:therapeutic use*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007783:Lactones; D017366:Serotonin Receptor Agonists; D013450:Sulfones; C116926:rofecoxib; D007052:Ibuprofen