Zolmitriptan

CHICAGO--The first randomized controlled trial to prospectively evaluate the efficacy of a triptan in the acute treatment of true menstrual migraine found that oral zolmitriptan provides significant and sustained relief, said Dr. Michael Tuchman of Palm Beach Neurological Center, Palm Beach Gardens, Fla.

Recurrence rates in this study were comparable with those seen in nonmenstrual zolmitriptan migraine studies. This contrasts with one study that reported a 24-hour recurrence rate in menstrual migraine of 53% for patients treated with sumatriptan subcutaneously and 52% for placebo (Obstet. Gynecol. 86[6]:911-16, 1995).

Until now, trials have looked retrospectively at this often hard to treat migraine population, or have included subjects who experience more than 10% of their attacks outside the menstrual window.

The patients in this study had true menstrual migraine, meaning that at least 90% of their attacks occurred during the menstrual window (from 2 days before to 5 days after the onset of menses). Women were recruited from 30 U.S. centers and randomized to zolmitriptan 2.5-mg tablet or placebo.

They were allowed to treat up to two migraine headaches per menstrual period, for up to 3 months, and were instructed to treat only migraines of moderate to severe intensity. The patients treated 625 migraine attacks with zolmitriptan and 529 with placebo, Dr. Tuchman said at the annual meeting of the American Headache Society. The primary end point was 2-hour headache response for all attacks treated.

Zolmitriptan was significantly more effective than placebo in achieving a 2-hour headache response, (66% vs. 33%, respectively). A significant headache response to zolmitriptan was observed starting at 1 hour, the earliest time point assessed (41% vs. 22%). Pain-free rates at 2 hours also were significantly higher for zolmitriptan than with placebo (28% vs. 9%).

Recurrence was reported in 29% of zolmitriptan-treated attacks and in 45% of placebo-treated attacks. The mean time to recurrence was longer for zolmitriptan than for placebo (10 hours vs. 7 hours).

Overall, drug-related adverse events were more frequent in those treated with zolmitriptan. Yet withdrawal due to adverse events was low: 2% for zolmitriptan and 1% for placebo. The most frequent adverse events were dizziness, throat tightness, paresthesia, somnolence, dry mouth, and nausea.

Dr. Tuchman is a consultant, speaker, and clinical investigator for AstraZeneca Pharmaceuticals, manufacturer of Zomig, a brand of zolmitriptan.

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