Treatment of severe, disabling migraine attacks in an over-the-counter population of migraine sufferers: results from three randomized, placebo-controlled studies of the combination of acetaminophen, aspirin, and caffeine

Objective: To examine the benefits of acetaminophen, aspirin, and caffeine (AAC) in the treatment of severe, disabling migraine attacks, in a population of migraine sufferers for whom over-the-counter (OTC) medications are appropriate. Background: Subjects (n = 1220) who met the International Headache Society criteria for migraine with or without aura were included in three independent clinical studies. Design/Methods: Post-hoc analysis of 172 subjects who met the criteria for severe, disabling migraine reported a history of migraine attacks characterized by at least severe pain and severe disability, and treated attacks with severe pain and at least severe disability. Subjects who usually vomited with 20% or more of their migraine attacks, and those with incapacitating disability (subjects who required bed rest for more than 50% of their attacks) were not eligible for enrollment. Results: From 1 h and continuing through 6 h postdose, the proportion of responders was significantly greater (p less than or equal to 0.01) for AAC than placebo. The pain intensity difference from baseline was significantly greater (p less than or equal to 0.05) for AAC than placebo from 0.5 h through 6 h. The proportion of subjects reporting improvement in functional disability, photophobia, and phonophobia was significantly greater for AAC than placebo from 2 h through 6 h postdose. Conclusions: The nonprescription combination of AAC was well tolerated and effective.