"Migraine headache is a neurologic disorder associated with significant disability and impaired quality of life, adversely affecting daily activity and work-related productivity for many persons" according to background information in the article. The authors state that approximately 11 percent of the U.S. population experiences migraines and the prevalence is thought to be about the same in other industrialized countries.
Jan Lewis Brandes, M.D., from the Nashville Neuroscience Group, Nashville, Tenn., and colleagues, evaluated the efficacy and safety of topiramate for migraine prevention during a 26-week study conducted at 52 North American outpatient clinical centers. Four hundred eight-three patients were randomized to four treatment groups: placebo or topiramate at 50 milligrams/day (mg/d), 100 mg/d, or 200 mg/d. From that group, 468 (87-percent women) were included in the analysis after some participants dropped out of the study, most often because of adverse side-effects from the medication, including paresthesia (tingling sensations), fatigue, and nausea.
"Mean (average) monthly migraine frequency decreased significantly for patients receiving topiramate at 100 mg/d [milligrams per day] (-2.1) and topiramate at 200 mg/d (-2.4) vs. placebo (-1.1)," the authors report. "Statistically significant reductions occurred within the first month with topiramate at 100 and 200 mg/d." The researchers found that the participants in the 100 mg/d and 200 mg/d had reductions in the number of days with migraines per month, and were also able to reduce their rescue medication use for headaches, such as aspirin, acetaminophen, triptans, and opioids.
"Topiramate showed statistically significant efficacy in migraine prevention within the first month of treatment, an effort maintained for the duration of the double-blind phase," the authors conclude. (JAMA. 2004;291:965-973. Available post-embargo at JAMA.com)
Editor's Note: Please see JAMA study for authors' financial disclosures. The Topiramate for Migraine Prevention study was funded by a grant from Johnson & Johnson Pharmaceutical Research and Development, LLC. The lead investigator sought sponsorship from Johnson & Johnson on the basis of clinical experience with topiramate. Other investigators were selected for participation on the basis of their clinical expertise and access to migraineurs.
Journal
JAMA