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Aspirin Is Efficacious for the Treatment of Acute Migraine


  • Richard B. Lipton MD,

  • Jerome Goldstein MD,

  • Jeffrey S. Baggish MD,

  • Alberto R. Yataco MD,

  • James V. Sorrentino PhD,

  • John N. Quiring PhD

  • From the Departments of Neurology, Epidemiology, and Population Health, Albert Einstein College of Medicine, Bronx, NY (Dr. Lipton); San Francisco Headache Clinic, San Francisco, CA (Dr. Goldstein); Medical & Regulatory Affairs, McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA (Dr. Baggish); IMR Clinical Trials, Towson, MD (Dr. Yataco); Healthcare Products Development, Inc, Norwalk, CT (Dr. Sorrentino); and QST Consultations, Allendale, Michigan, Stephen Garreffa, Bayer HealthCare, Morristown, NJ (Dr. Quiring).

Address all correspondence to Dr. Richard B. Lipton, Departments of Neurology, Epidemiology and Population Health, Albert Einstein College of Medicine, 1165 Morris Park Avenue, Room 332, Bronx, NY 10467.


Background.—More than 50% of migraine sufferers rely on over-the-counter medications for the treatment of migraine. Along with other over-the-counter products, aspirin is considered by the US Headache Consortium to be an option for first-line migraine treatment. This study assessed the efficacy and tolerability of aspirin versus placebo for the acute treatment of a single acute attack of migraine.

Methods.—This prospective, randomized, double-blind, parallel-group, placebo-controlled study evaluated the efficacy of a single, 1000-mg dose of aspirin for the treatment of acute moderate to severe migraine, with or without aura. Subjects recorded all study evaluations in a diary at baseline and at .5, 1, 2, 3, 4, 5, 6, and 24 hours after treatment. Pain was rated on a 4-point ordinal scale from no pain to severe pain. The primary efficacy end point was headache response at 2 hours. Secondary efficacy parameters included reduction of nausea, photophobia and phonophobia, pain intensity difference, and headache recurrence at 24 hours.

Results.—Of 485 subjects enrolled, 409 took study medication and 401 treated a confirmed migraine attack (201 with aspirin and 200 with placebo). Baseline demographic and migraine characteristics were not significantly different between groups. The 2-hour headache response rate was 52% with aspirin versus 34% with placebo (P < .001). Aspirin was significantly more effective than placebo for pain reduction beginning 1 hour after dosing (P < .001) and continuing throughout the 6-hour evaluation period. Significantly (P < .05), more subjects were pain free from the 1-hour evaluation through the 6-hour evaluation. Of the aspirin-treated subjects, 20% were pain free at 2 hours versus only 6% of placebo-treated subjects. At 24 hours, the headache recurrence rate was 21.8% for aspirin (23 of 105 subjects) and 27.7% for placebo (19 of 68 subjects). Only 34% of aspirin-treated subjects needed rescue medication at 24 hours compared with 52% of placebo-treated subjects (P < .001). Aspirin was well tolerated, and adverse events were not significantly different between groups.

Conclusions.—This study demonstrates that aspirin is safe and effective for treatment of acute migraine in appropriately selected patients.