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Menstrual Migraines May Be Preventable: Presented at AAN

By Charlene Laino

HONOLULU, HI -- April 7, 2003 -- Frovatriptan is effective in preventing menstruation-associated migraines, a double-blind, placebo-controlled trial shows.

Stephen Silberstein, MD, Director of the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania, United States, presented the findings here on April 2^nd at the 55^th Annual Meeting of American Academy of Neurology.

Approximately 9 million American women experience migraines and about 60% of them report an increased number of headaches in association with their menstrual periods, Dr. Silberstein said. The three-way cross-over study enrolled 545 women who had experienced menstruation-associated migraines for an average of 12 years.

Starting 2 days before their period and continuing for 6 days, the patients were given either placebo, a 2.5 milligram dose of frovatriptan once a day or a 2.5 milligram dose of the drug twice a day. A double loading dose was taken on the first day. After 3 months on one of the regimens, the women were switched over to another regimen, and then after another 3 months, to the third regimen.

The study showed that both dose levels of frovatriptan were significantly superior to placebo in reducing the incidence of menstrually associated migraine headache (p<0.0001), and that the higher dose of frovatriptan was significantly superior to the lower dose (p<0.0001). Headaches resolved in 50% of patients treated with the higher dose of frovatriptan, 39% of patients taking the lower dose of the medication, and 26% taking placebo.

Both dose levels of frovatriptan significantly reduced menstrually associated migraine severity (p<0.0001) and duration (p<0.0001), functional impairment (p<0.0001) and use of rescue medication (p<0.003 for the once-daily dose, p<0.0001 for the twice-daily dose) in a dose-dependent manner, Dr. Silberstein reported.

Side effects, including nausea, dizziness, headache and fatigue, were similar in patients taking the drug and those on placebo, he said.

The study was sponsored in part by Elan, maker of frovatriptan.

"Since frovatriptan is already approved by the U.S. Food and Drug Administration for the treatment of acute migraines, physicians may want to discuss the option with female patients who suffer from menstrually associated migraines," Dr. Silberstein said in an interview.

Triptans are a relatively new class of designer drugs that work directly to turn off migraines, according to Dr. Silberstein. They are thought to pack a triple punch against the headaches, reducing inflammation of certain blood vessels in the brain thought to cause pain, blocking the release of irritating neuropeptides in the nerve endings and preventing transmission of pain signals from the lining of the brain to the brain itself, he said.


[Study title: Frovatriptan, a Selective 5HT1B/1D Agonist, Is Effective for Prophylaxis of Menstrually Associated Migraine. Abstract: S15.004]

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