A review of three randomized controlled studies reveals robustly statistically significant results for the drug combination, regardless of varying patient demographics.
PHILADELPHIA—A fixed combination of acetaminophen, aspirin, and caffeine offered significantly greater migraine relief than placebo, and the treatment was consistent regardless of age, gender, or race, according to research presented at the 14th Congress of the International Headache Society.
“Migraine sufferers have added evidence that combination analgesics are an alternative headache treatment,” Jerome Goldstein, MD, Director of the San Francisco Headache Clinic, told Neurology Reviews. “Cost effectiveness is a significant consideration in migraine treatment, and this presentation gives consumers added information for their confidence in using appropriate analgesic products.”
Dr. Goldstein’s group reviewed three identically designed randomized placebo-controlled multicenter trials, which included 1,220 adults with a history of migraine who were treated with either the combination of 250 mg of acetaminophen, 250 mg of aspirin, and 65 mg of caffeine (AAC) or placebo. The investigators focused on the primary end points of pain intensity difference (PID) and headache responder percentage (HRP). The pooled data were evaluated at 30 minutes and at one, two, three, four, and six hours after treatment, relative to patients’ age, gender, race, baseline pain intensity, and presence or absence of aura at baseline. Pain was assessed on a 4-point scale, in which no pain equals 0 and severe pain equals 3.
PID response was significantly greater with AAC versus placebo for all subgroup analyses at the primary end point of two hours and at most other time points. PID values with AAC increased or were maintained throughout the six-hour period in all subgroups. Although differences within subgroups in PID response throughout the course of the evaluation period were generally small, the researchers found that PID response was lowest in patients older than 50.
HRP was significantly greater for AAC versus placebo for all subgroup analyses at the primary end point of two hours and at most other time points. The percentages increased or were maintained throughout the six-hour period.
“The most surprising finding was the consistency of results over all three studies, which were conducted according to the most rigorous standards, not allowing any exceptions or deviations from the protocol,” Dr. Goldstein explained. “The results from these three studies are robustly statistically significant considering age, gender, race, baseline pain intensity, and presence or absence of aura at baseline. Thus, the studies confirm without question the role of AAC as an effective and safe treatment option for moderate to severe migraine headaches.”
—Rebecca K. Abma