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From Thomas Jefferson University (Dr. Silberstein), Philadelphia, PA; Elkind Headache Center (Dr. Elkind), Mt. Vernon, NY; Headache Care Center (Dr. Schreiber), Springfield, MO; and Minerva Pharmaceutical Consulting Ltd (Dr. Keywood), London, UK.
Drs. Silberstein, Elkind, and Schreiber served as principal investigators on the study. Please see appendix for a complete list of Frovatriptan MAM study investigators.
Address correspondence and reprint requests to Dr. Stephen Silberstein, Jefferson Headache Center, 111 S. 11th Street, 8130 Gibbon, Philadelphia, PA 19107; e-mail: Stephen.Silberstein{at}Jefferson.edu
Background: Menstrually associated migraine (MAM) is often prolonged and difficult to manage with conventional therapies. Frovatriptan is a new selective 5HT1B/1D receptor agonist indicated for short-term management of migraine. It has a long half-life and good tolerability. These characteristics suggest that frovatriptan may be useful for the intermittent prevention of MAM.
Methods: The study was a randomized, double-blind, placebo-controlled, three-way crossover design. Patients treated each of three perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg QD, and frovatriptan 2.5 mg BID. The 6-day treatment started 2 days before the anticipated start of MAM headache. The primary efficacy endpoint was incidence of MAM headache during the 6-day PMP.
Results: The population comprised 546 women (mean age, 37.6 years). Use of frovatriptan reduced the occurrence of MAM headache. The incidence of MAM headache during the 6-day PMP was 67% for placebo, 52% for frovatriptan 2.5 mg QD, and 41% for frovatriptan 2.5 mg BID. Both frovatriptan regimens were superior to placebo (p < 0.0001), and the BID regimen was superior to the QD regimen (p < 0.001). Both frovatriptan regimens also reduced MAM severity (p < 0.0001), duration (p < 0.0001), and the use of rescue medication (p < 0.01 QD; p < 0.0001 BID) in a dose-dependent manner. The incidence and type of adverse events for both regimens were similar to placebo and consistent with those reported for short-term migraine management.
Conclusion: Frovatriptan given prophylactically for 6 days was effective in reducing the incidence of menstrually associated migraine. More than half of patients who used frovatriptan 2.5 mg BID had no menstrually associated migraine headache during the 6-day perimenstrual period. The findings are consistent with the long duration of action and good tolerability of frovatriptan observed in short-term migraine management.
Received April 18, 2003. Accepted in final form May 21, 2004.
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