Abstract
BackgroundTopiramate is approved for the prophylaxis (prevention) of migraine headache in adults. The most common adverse events in the three pivotal, randomized, double-blind, placebo-controlled trials were paresthesia, fatigue, cognitive impairment, anorexia, nausea, and taste alteration. In these trials, topiramate 100 mg/d significantly improved Migraine-Specific Questionnaire (MSQ) scores versus placebo (p < 0.001). The MSQ measures how much migraine limits/interrupts daily performance. Pooled analyses of pivotal trial data were conducted to further assess how topiramate 100 mg/d affects daily activities and patient functioning.MethodsMean MSQ and Medical Outcome Study Short Form 36 (SF-36) change scores (baseline to each double-blind assessment point) were calculated for pooled intent-to-treat (ITT) patients. Additionally, pooled ITT patients receiving topiramate 100 mg/d or placebo were combined and divided into two responder groups according to percent reduction in monthly migraine frequency: < 50% responders or ≥ 50% responders. Between-group differences were assessed using analysis of covariance.ResultsOf 756 patients (mean age 39.8 years, 86% female), 384 received topiramate 100 mg/d and 372 placebo. Topiramate significantly improved all three MSQ domains throughout the double-blind phase versus placebo (p = 0.024 [week 8], p < 0.001 [weeks 16 and 26] for role prevention; p < 0.001 for role restriction and emotional function [all time points]). Topiramate 100 mg/d significantly improved SF-36 physical component scores (PCS) throughout the double-blind phase versus placebo (p < 0.001, all time points) and significantly improved mental component scores (MCS) at week 26 (p = 0.043). The greatest topiramate-associated improvements on SF-36 subscales were seen for bodily pain and general health perceptions (p < 0.05; weeks 8, 16, and 26), and physical functioning, vitality, role-physical, and social functioning (p < 0.05; weeks 16 and 26). Significantly greater improvements in all three MSQ domains, as well as the PCS and MCS of SF-36, were observed for ≥ 50% responders versus < 50% responders (p < 0.001). Significantly greater percentages of topiramate-treated patients were ≥ 50% responders versus placebo (46% versus 23%; p < 0.001).ConclusionTopiramate 100 mg/d significantly improved daily activities and patient functioning at all time points throughout the double-blind phase. Daily function and health status significantly improved for those achieving a ≥ 50% migraine frequency reduction.
Highlights
Migraine is a significant detriment to daily functioning and productivity during, and to a certain extent before and after, attacks
Outcome measures Migraine-Specific Questionnaire (MSQ) and Short Form 36 (SF-36) data were collected at baseline and at weeks 8, 16, and 26
Demographic and baseline characteristics of patients Demographics and baseline MSQ and SF-36 scores for the pooled ITT population are presented in Tables 1 and 2
Summary
Migraine is a significant detriment to daily functioning and productivity during, and to a certain extent before and after, attacks. In three large, randomized, double-blind, placebo-controlled, 6-month, migraine prevention trials [3,4,5,6], topiramate 100 mg/d (50 mg bid) was associated with a significant and sustained decrease in mean monthly migraine frequency, observed as early as the first month of therapy. The most common adverse events in topiramatetreated patients in these trials were paresthesia (50.5%), fatigue (15.0%), anorexia (14.5%), upper respiratory infection (14.0%), cognitive impairment (13.7%), nausea (13.2%), diarrhea (11.1%), and weight decrease (9.1%). The most common adverse events in the three pivotal, randomized, double-blind, placebocontrolled trials were paresthesia, fatigue, cognitive impairment, anorexia, nausea, and taste alteration. In these trials, topiramate 100 mg/d significantly improved Migraine-Specific Questionnaire (MSQ) scores versus placebo (p < 0.001). Pooled analyses of pivotal trial data were conducted to further assess how topiramate 100 mg/d affects daily activities and patient functioning
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