From the Elkind Headache Center, Mount Vernon, NY (Dr. Elkind); Central Cardiac Testing, Greenbelt, Md (Drs. Satin and Nila); and Minerva Pharmaceutical Consulting, Surrey, United Kingdom (Dr. Keywood).
Frovatriptan Use in Migraineurs With or at High Risk of Coronary Artery Disease
Article first published online: 7 MAY 2004
Headache: The Journal of Head and Face Pain
Volume 44, Issue 5, pages 403–410, June 2004
How to Cite
Elkind, A. H., Satin, L. Z., Nila, A. and Keywood, C. (2004), Frovatriptan Use in Migraineurs With or at High Risk of Coronary Artery Disease. Headache: The Journal of Head and Face Pain, 44: 403–410. doi: 10.1111/j.1526-4610.2004.04071.x
- Issue published online: 7 MAY 2004
- Article first published online: 7 MAY 2004
- Accepted for publication January 13, 2004.
- coronary 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 ≥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.