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Topiramate for Migraine Prevention in Adolescents: A Pooled Analysis of Efficacy and Safety
Author(s) -
Winner Paul,
Gendolla Astrid,
Stayer Catherine,
Wang Steven,
Yuen Eric,
Battisti Wendy P.,
Nye Jeffrey S.
Publication year - 2006
Publication title -
headache: the journal of head and face pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.14
H-Index - 119
eISSN - 1526-4610
pISSN - 0017-8748
DOI - 10.1111/j.1526-4610.2006.00610.x
Subject(s) - topiramate , migraine , placebo , medicine , post hoc analysis , adverse effect , anesthesia , randomized controlled trial , clinical trial , pediatrics , epilepsy , psychiatry , alternative medicine , pathology
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.