Frovatriptan use in migraineurs with or at high risk of coronary artery disease.

OBJECTIVE: To investigate the cardiovascular effects of frovatriptan 2.5 mg during a migraine attack in patients with, or at high risk of, coronary artery disease. BACKGROUND: Rare occurrences of myocardial ischemia and coronary and peripheral vasospasm associated with the use of sumatriptan have triggered concern over the vasoconstrictor properties of the triptan class of drugs. METHODS: This randomized, double-blind, placebo-controlled, parallel-group study was conducted in 14 US private headache referral centers or clinics. Seventy-five patients, aged 18 years and older, with a history of migraine who were at high risk (Framingham score > or =14) of or who had previously documented coronary artery disease were evaluated. RESULTS: Incidence of clinically significant electrocardiogram changes was higher at all time points postdose with placebo than with frovatriptan, reaching statistical significance at 4 hours (40% versus 19%, P=.026). Similar proportions of patients had ischemia documented on Holter monitoring in the placebo (13%) and frovatriptan (11%) groups, and the incidence of arrhythmias was higher in the placebo group (11% versus 3%). There were no clinically significant changes in heart rate or blood pressure in either group. Adverse event profiles were similar for placebo and frovatriptan. CONCLUSIONS: In this exploratory study of migraineurs with, or at high risk of, coronary artery disease, frovatriptan 2.5 mg was well tolerated and not associated with an increase in cardiovascular monitoring abnormalities.