Topiramate for Migraine Prevention in Adolescents: A Pooled Analysis of Efficacy and Safety

• Published in: Headache 2006-11, Vol.46 (10), p.1503-1510
• Main Authors: Winner, Paul, Gendolla, Astrid, Stayer, Catherine, Wang, Steven, Yuen, Eric, Battisti, Wendy P., Nye, Jeffrey S.
• Format: Article
• Language: English
• Subjects: Adolescent; Biological and medical sciences; Cardiovascular system; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fructose - adverse effects; Fructose - analogs & derivatives; Fructose - therapeutic use; Humans; Male; Medical sciences; migraine; Migraine Disorders - prevention & control; Neurology; Neuropharmacology; Neuroprotective Agents - adverse effects; Neuroprotective Agents - therapeutic use; Neurotransmitters. Neurotransmission. Receptors; Pharmacology. Drug treatments; prevention; prophylaxis; Serotoninergic system; topiramate; Vascular diseases and vascular malformations of the nervous system; Vasodilator agents. Cerebral vasodilators
• ISSN: 0017-8748; 1526-4610
• DOI: 10.1111/j.1526-4610.2006.00610.x

Objective.—To characterize the efficacy and safety of topiramate for migraine prevention in adolescents from 3 randomized, 26‐week, double‐blind, placebo‐controlled trials. Background.—Limited information is available regarding the efficacy and safety of prophylactic medications for treatment of adolescent migraine, a significant health problem. In studies that included adults and children, topiramate 100 and 200 mg/day were effective and generally well‐tolerated in the prevention of migraine headache. Methods.—We performed a post hoc subset analysis of the efficacy and safety data from the 51 patients, ages 12–17 years, enrolled in 3 pivotal trials of topiramate for migraine prophylaxis. Results.—Daily treatment with topiramate 50, 100, and 200 mg for 26 weeks reduced monthly migraine frequency from baseline 46% (P= .07), 63% (P= .02), and 65% (P= .04), respectively, compared with placebo (16%). Similarly, topiramate reduced both the monthly mean number of migraine days (1, 4, and 5 days for topiramate 50, 100, and 200 mg/day, respectively, vs 1 day for placebo) and percentage of days during which acute migraine medications were administered (59%, 54%, and 67% for topiramate 50, 100, and 200 mg/day, respectively, vs 42% for placebo), although the treatment differences did not reach nominal statistical significance. Topiramate 200 mg/day did not appear to offer greater efficacy than 100 mg/day. Treatment was generally well‐tolerated, although adverse events were most frequent in the 200 mg/day dose group. Conclusions.—This post hoc subset analysis suggests that topiramate 100 and 200 mg/day, and possibly 50 mg/day, administered prophylactically for 26 weeks may reduce migraine in adolescents.