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Low Dose Almotriptan Provides Rapid Pain Relief: Presented at ANA

By Paula Moyer

SAN FRANCISCO, CA -- November 6, 2003 -- Patients are more likely to report pain relief and complete freedom from migraine pain at 1- and 2-hour intervals when treated with 12.5 mg almotriptan (Axert) than when treated with placebo, according to findings presented here October 20^th at the 128^th Annual Meeting of the American Neurological Association.

"This dose of almotriptan was associated with a rapid onset and a high degree of pain relief," said Tad Seifert, MD, chief resident in neurology, Houston Headache Clinic, University of Texas-Houston, United States. "It was actually tolerated better than placebo."

Dr. Seifert noted that 25 mg of almotriptan is more frequently prescribed than 12.5 mg.

Dr. Seifert assisted the principal investigator in the clinical assessments for this trial. The principal investigator, Ninan T. Mathew, MD, DM, FRCPC, is director of the Houston Headache Clinic.

Dr. Mathew randomised 549 patients to receive either 12.5 mg of almotriptan or placebo for treatment of headache. The patients, who ranged in age from 18 to 65 years old, had had a history of migraine for more than 1 year, had 1 to 6 migraine attacks per month, and met the International Headache Society criteria for migraine.

The study protocol defined pain relief as a decrease in pain severity from moderate or severe before treatment to mild or no pain. The pain-free state was defined as a decrease in severity from moderate or severe before treatment to no pain after treatment. Assessments were made before treatment, and at 1 and 2 hours after treatment. Dr. Mathew analysed these endpoints after the patients had been treated for 3 successive migraine attacks.

At 1 hour, 34.5% of patients in the almotriptan arm and 21.6% of those in the placebo arm reported pain relief. At this time point, a pain-free status was reported by 12.5% of the almotriptan patients and 5.7% of the placebo patients.

At 2 hours, 64.6% of treated patients and 33.9% of placebo patients reported pain relief. The pain-free rate at 2 hours was 38.8% for the treatment arm and 15.5% for the placebo arm. The difference between the 2 arms was statistically significant for pain relief and a pain-free status for both time points, Dr. Mathew reported (p<0.05 for all).

These findings show that a lower dose of almotriptan than conventionally used is effective at providing rapid pain relief, as early as 1 hour after treatment, said Dr. Seifert. Paresthesia was the only adverse effect reported more frequently in the treatment group over placebo, he said.

Axert is manufactured by Pharmacia. This study was supported by the Pharmacia Corporation speaker's bureau.


[Study Title: Almotriptan Efficacy in Achieving Pain Relief and Pain-Free Status 1 and 2 Hours After Treatment of Acute Migraine. Abstract 50]

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