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Analysis of Pooled Data From Two Pivotal Controlled Trials on the Efficacy of Topiramate in the Prevention of MigraineFrom the Diamond Headache Clinic in Chicago, Ill, and Midwestern University Chicago College of Osteopathic Medicine in Downers Grove, Ill (Dr Freitag); North Shore Pain Services in Valley Stream, NY (Dr Forde); Johnson & Johnson Pharmaceutical Research and Development LLC in Raritan, NJ (Drs Neto and Wang, Ms Schmitt); and Ortho-McNeil Neurologics Inc in Titusville, NJ (Drs Wu and Hulihan). Address correspondence to Fred G. Freitag, DO, Diamond Headache Clinic, 467 W Deming Place, Chicago, IL 60614-1881. E-mail: dhcdoc{at}aol.com
Context: A substantial proportion of the patient population with migraine headache should be considered for preventive treatment based on the frequency and disability associated with this disorder. Use of the anticonvulsant topiramate was previously examined in two large, double-blind, randomized, placebo-controlled clinical trials of a subset of patients who have 3 to 12 migraine episodes per month. Objective: To better characterize the efficacy of topiramate for prevention of migraine, with or without aura, by pooling and analyzing data from the two large clinical trials. Methods: The pooled intent-to-treat population included 937 patients receiving topiramate at one of three dosages (50 mg/d, 100 mg/d, 200 mg/d) or placebo. Outcome measures included change in mean monthly migraine frequency and categorical responder rate throughout the 26-week doubleblind phase.
Results: At daily doses of 100 and 200 mg, topiramate was associated
with significant reductions in mean monthly migraine frequency throughout the
double-blind phase compared with placebo (P<.001). Significantly
more patients treated with these topiramate doses exhibited high-percentage
reductions in monthly migraine frequency (
Conclusion: Pooled efficacy data from two large, similarly designed,
placebo-controlled migraine-prevention trials demonstrated that a
statistically significant proportion of patients using topiramate met or
exceeded two main outcome guidelines recommended by the International Headache
Society (
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