Zolmitriptan

Migraine Spray Does Well in Real-Life Trials

SAN FRANCISCO -- Zolmitriptan nasal spray to treat migraine headache performed well in a randomized, double-blind, placebo-controlled study of 912 patients designed to mimic use in real-life settings, Dr. Marek Gawel said in a poster presentation at the annual meeting of the American Neurological Association.

In many clinical trials of migraine therapies, patients are instructed to treat migraine attacks when the headache reaches a specified intensity or to treat within a specified time period. The current trial randomized patients to treat a single migraine attack of any intensity with zolmitriptan 5-mg nasal spray or placebo. Patients could use the spray at any time during the migraine attack.

One hour after treatment, 15% in the zolmitriptan group and 5% in the placebo group reported on diary cards that they achieved total symptom relief, meaning they were free of pain, nausea, photophobia, and phonophobia, said Dr. Gawel, of the University of Toronto. AstraZeneca, which makes zolmitriptan, funded the study.

A significant difference between the two treatment groups was seen within 10 minutes for improving headache alone and within 30 minutes for improving total symptoms.

Most patients at baseline had headaches of moderate intensity. Zolmitriptan provided total symptom relief at 2 hours for 33% of patients with moderate headaches, 24% with severe headaches, and 61% with mild headaches.

At 2 hours, 47% in the zolmitriptan group and 19% in the placebo group found that treatment reduced the migraine attack's impact on normal activities. Adverse events were reported by 20% on placebo and by 50% using zolmitriptan, most commonly a bad taste from zolmitriptan (16%).

In a separate, open-label study, 538 patients were given zolmitriptan nasal spray for the first time and allowed to use it for any migraine attacks over a 6-month period. If they were not pain free after 2 hours, they could spray a second dose or take an escape medication.

Many patients used the drug frequently: 44% treated a mean of three or more attacks per month. Of a total of 20,717 attacks treated, 54% were pain free after 2 hours. A single dose sufficed in a majority of attacks, said Dr. Bruce R. Charlesworth of AstraZeneca, Macclesfield, England.

The drug was well tolerated. Efficacy did not decrease with extended use, he added.

BY SHERRY BOSCHERT

San Francisco Bureau

COPYRIGHT 2004 International Medical News Group
COPYRIGHT 2004 Gale Group