title: Topiramate in the preventive treatment of episodic migraine: a combined analysis from pilot, double-blind, placebo-controlled trials.
abstract: The safety and efficacy of medications for preventive treatment of migraine is the subject of current concern and investigation in health care. Two single-center, double-blind, placebo-controlled studies were conducted to evaluate the efficacy and safety of topiramate for migraine prophylaxis. Seventy patients with a diagnosis of migraine were randomly assigned to topiramate-treated and placebo groups. The studies consisted of a 4-week baseline phase, a 6-8 week titration, and 8-12 weeks of maintenance. Topiramate was titrated from an initial dose of 25 mg/day to a target dose of 100 mg BID. The primary efficacy measure, the mean 28-day migraine frequency, was lower in topiramate-treated patients than in the placebo group (3.2 versus 3.8, P=.001). Similarly, topiramate treatment resulted in a significantly greater mean reduction in migraine frequency than did placebo (1.55 versus 0.47, P=.001) and a significantly higher responder rate (35.3% versus 8.3%, P=.008). Paresthesia was the most common side effect reported with topiramate treatment. Other topiramate-associated adverse events included altered taste, memory impairment, diarrhea, and appetite suppression/weight loss. The rates of discontinuation were similar for the topiramate group (n=10) and the placebo group (n=8). These results suggest that topiramate is effective and well tolerated in the preventive treatment of migraine headaches.
authors.affiliation: Department of Neurology, Harvard Medical School School and Beth Israel Deaconess Medical Center in Boston, Massachusetts, USA. kedwards@vtneuro.com.
authors.forename: Keith R
authors.initials: KR
authors.lastname: Edwards
authors.forename: Doreen L
authors.initials: DL
authors.lastname: Potter
authors.forename: Shu-Chen
authors.initials: SC
authors.lastname: Wu
authors.forename: Marc
authors.initials: M
authors.lastname: Kamin
authors.forename: Joseph
authors.initials: J
authors.lastname: Hulihan
mesh_terms: D000328:Adult; D015992:Body Mass Index; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D000077236:Topiramate
chemical_list: D018696:Neuroprotective Agents; D000077236:Topiramate; D005632:Fructose