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: Keith R Edwards, Doreen L Potter, Shu-Chen Wu, Marc Kamin, Joseph Hulihan
• Journal: CNS spectrums (CNS Spectr) Vol. 8 Issue 6 Pg. 428-32 (Jun 2003) ISSN: 1092-8529 [Print] United States
• PMID: 12858132 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Neuroprotective Agents
• Topiramate
• Fructose

Topics

• Adult
• Body Mass Index
• Double-Blind Method
• Female
• Fructose (adverse effects, analogs & derivatives, therapeutic use)
• Humans
• Male
• Middle Aged
• Migraine Disorders (prevention & control)
• Neuroprotective Agents (adverse effects, therapeutic use)
• Pilot Projects
• Topiramate