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More Migraine Relief Seen with Over-the-Counter Combination than with Sumatriptan: Presented at AAN

By Paula Moyer

HONOLULU, HI -- April 4, 2003 -- Patients are more likely to get relief from a migraine episode if they use an over-the-counter (OTC) treatment that combines acetaminophen, aspirin, and caffeine at the first sign of an attack than if they use 50 mg of sumatriptan (Imitrex).

Jerome Goldstein, MD, presented the findings here April 1^st at the 55^th Annual Meeting of the American Academy of Neurology.

"Both of the treatments used in the study are first-line treatments for migraine," said Dr. Goldstein, who practices in San Francisco. "We wanted to compare their efficacy, because the OTC treatment may have advantages of safety, convenience, and cost."

The study, known as Placebo Comparison of Acetaminophen, Aspirin and Caffeine vs. Sumatriptan in the Early Treatment of Migraine (ASSET), also found that both sumatriptan and the OTC combination (Excedrin) are more effective than placebo, he said.

The subjects who took the OTC combination at the first sign of a migraine episode had significantly superior pain relief and sustained relief than the sumatriptan patients, Dr. Goldstein reported. He added that the OTC preparation was also associated with meaningful relief earlier and with less use of rescue medication than was sumatriptan

Dr. Goldstein said that the study was unique because most placebo-controlled trials of migraine medications compare prescription medications head-to-head rather than comparing an OTC combination to a prescription treatment.

In this multicenter, randomized, double-blind, parallel-group, single-dose, placebo-controlled study, investigators recruited 171 patients who had been diagnosed with migraine, without or with aura, by International Headache Society criteria. They excluded subjects who had a history of vomiting during more than 20% of migraine episodes or who required bed rest during more than 50% of migraine episodes.

At the beginning of each migraine attack, the participants rated their pain intensity, disability, and presence of other common migraine symptoms, including nausea, vomiting, photophobia, and phonophobia. They then rated these variables and pain relief at 15, 30, 45, 60, and 90 minutes after dosing, and at 12, 3, 4 and 24 hours after dosing. The participants timed the beginning of meaningful migraine relief with a stopwatch.

Dr. Goldstein and colleagues established the total pain intensity difference, from the beginning of the attack to 4 hours later, as the primary end point.

There were 69 patients in the OTC group, 67 in the sumatriptan group, and 35 in the placebo group. The subjects' demographic characteristics were similar, as were the baseline characteristics of the treated attack. Among the subjects, 54% had a history of at least severe disability associated with migraine attacks, with 60% using prescription medications, with or without non-prescription medications.

At the beginning of the migraine attack, 72% of subjects reported moderate or severe pain; 24% said that their activities were significantly limited during the attacks.

The investigators found the OTC preparation to be significantly more effective than sumatriptan regarding total pain intensity difference four hours after the onset of the attack (P=0.014). They also found the OTC medication superior to sumatriptan for total pain relief at 4 hours (P=0.022).

Among the OTC subjects, 87% had responded to treatment at 2 hours, compared to 75% of sumatriptan subjects (P=0.045). The differences seen 24 hours after treatment showed that 66% of the OTC subjects had sustained relief, compared to 49% of the sumatriptan group (P=0.021).

Median time to meaningful migraine relief occurred 32 minutes earlier in the OTC group than in the sumatriptan group (P=0.179). At 4 hours after dosing, fewer subjects in the 1.4% of the OTC group required rescue medication, compared to 11.9% of the sumatriptan group (P=0.043). The investigators documented no serious adverse events were reported. They noted that one sumatriptan subject reported chest tightness, and 15 OTC subjects reported gastrointestinal events, compared to five of the sumatriptan subjects.

Bristol-Myers Squibb Company, which manufactures Excedrin, funded the ASSET study.


[Study title: A Placebo-Controlled Comparison of the Combination of Acetaminophen, Aspirin, and Caffeine with Sumatriptan Succinate in the Early Treatment of Migraine: Results from the Asset Trial. Abstract S22.005]

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