Rofecoxib in the prevention of perimenstrual migraine: an open-label pilot trial.

Objective: To investigate the effectiveness of rofecoxib in the prevention of perimenstrual migraine.

Background: Nonsteroidal anti-inflammatory drugs have demonstrated benefit in reducing the frequency and intensity of menstrual migraine when administered perimenstrually. Anti-inflammatory drugs, however, may not be well tolerated and can produce gastrointestinal irritation. Rofecoxib, a selective cyclooxygenase-2 inhibitor, has anti-inflammatory and analgesic properties, and a significantly improved gastrointestinal tolerability profile.

Methods: A pilot study was conducted in which patients with a history of menstrually associated migraine and experiencing at least one migraine monthly during the perimenstrual period were enrolled. Patients who completed a baseline diary for the first month were randomized to receive either rofecoxib 25 mg or 50 mg daily for 10 days, starting 5 days before menstrual flow. Headaches experienced during this 10-day period were recorded in the patient's diary. Patients continued rofecoxib for 2 consecutive menstrual cycles. Mean migraine frequency, intensity, and duration as well as patient's level of functioning during the 2 cycles were compared with baseline.

Results: Fourteen patients completed baseline and rofecoxib dosing for 2 menstrual cycles. Mean migraine frequency decreased from 5.6 to 2.6 migraines per menstrual cycle (P=.005). Eight (57%) of 14 patients had a > or = 50% reduction in headache frequency. No significant improvement in headache intensity, duration, and functional impairment were observed. Both doses of rofecoxib were well tolerated with no statistical difference in patient response between the doses.

Conclusion: Rofecoxib at a perimenstrual daily dose of 25 or 50 mg demonstrated a significant reduction in frequency of perimenstrual migraine. A double-blind, placebo-controlled trial of rofecoxib in the prevention of perimenstrual migraine is warranted.