Results from the first published head-to-head study of over-the-counter (OTC) analgesics for acute migraine, presented today at the 10th Congress of the International Headache Society, demonstrate that a two-tablet dose of the triple-formula combination of aspirin 500 mg., acetaminophen 500 mg. and caffeine 130 mg. (AAC) provides significantly superior overall analgesic efficacy and faster onset of meaningful pain relief than a two-tablet, 400 mg. dose of ibuprofen (IB).

In the study, 1,555 patients who met International Headache Society (IHS) diagnostic criteria for migraine with or without aura were randomized to receive a single, two-tablet dose of AAC (n=669), IB (n=666), or placebo (n=220). AAC provided significantly greater total pain relief (TOTPAR) than IB at two (p<0.003) and four hours (p<0.004) postdose; both treatments were significantly superior to placebo. Additionally, among AAC-treated patients, the median time to onset of meaningful migraine relief was 20 minutes faster than that reported by IB-treated patients; both treatments brought about relief significantly faster than placebo. For headache response at two hours, once recognized as the standard measure of analgesic efficacy, AAC was also significantly superior to IB (p<0.046) and placebo (p<0.010); IB failed to reach statistical significance versus placebo (p<0.314) at the same time point.

According to investigator Jerome Goldstein, M.D., director of the San Francisco Clinical Research Center and Headache Clinic, "With many migraine sufferers self-treating with OTCs, the rigorous data from our study will help medical professionals counsel their patients about the most appropriate choices in migraine medication."

The multi-center study was conducted at nineteen sites, including the San Francisco Clinical Research Center and Headache Clinic, from July 1999 to February 2000 using a double-blind, randomized, single-dose, double-dummy, parallel-group design. Subjects had experienced attacks at least once every 2 months, but no more than 6 times monthly over the previous year. For the first time ever in an OTC trial for migraine, a typical untreated attack featured headache pain of at least moderate intensity. By accepting "all-comers," even those with incapacitating pain and severe associated symptoms, investigators have blunted criticisms of earlier OTC migraine studies, all of which have excluded the most severely affected migraine patients.

"Part of the clinical significance of this study is that it helps validate caffeine's important role in the relief of even the most severe migraine attacks," said Dr. Goldstein. "The caffeine in AAC enhances the potency of its component analgesics, as well as the body's ability to metabolize them, which simultaneously increases overall efficacy and speed of onset."

The AAC combination used in the study is available as Excedrin(R) Migraine. The brand of ibuprofen used was Advil(R) tablets.

Migraine is a chronic condition that affects about 28 million Americans. According to the IHS, migraine is characterized by a throbbing or pulsing pain on one side of the head that is accompanied by nausea or vomiting, sensitivity to light or sound, and, in about 15 percent of cases, visual disturbances. Studies have shown that migraine can have a significant negative impact on productivity at work and on quality of life.