Objective: To assess changes in health-related quality of life (HRQoL) measures among patients receiving topiramate (TPM) 100 mg/d in two divided doses for migraine prevention in three randomized, double-blind, placebo-controlled, 26-week trials with similar protocols and study populations.
Background: Migraine substantially impairs HRQoL and work productivity before, during, and after attacks. Approximately 50% of patients with migraine could be recommended for preventive therapies, yet only 3% to 5% of patients receive them. TPM is an effective and generally well-tolerated migraine prophylactic (preventive) therapy for adults, as demonstrated in several randomized, double-blind, placebo-controlled trials. The most common adverse events in double-blind, placebo-controlled studies of TPM in migraine prevention are paresthesia, fatigue, anorexia, nausea, taste alteration, and diarrhea.
Design and methods: The Migraine-Specific Questionnaire (MSQ, version 2.1) was used to assess the effect of TPM 100 mg/d on the functionality and HRQoL of randomized intent-to-treat (ITT) and study-completer populations pooled from three randomized, double-blind, placebo-controlled trials. MSQ scores (0 to 100, higher score indicates better functioning) were assessed for the following three domains: role restriction (examines the degree to which performance of daily activities is limited by migraine), role prevention (examines the degree to which performance of daily activities is interrupted by migraine), and emotional function (examines feelings of frustration and helplessness due to migraine). Between-group differences from baseline in mean MSQ domain scores for TPM 100 mg/d and placebo were compared using a mixed-effects model with piecewise linear regression. Effect sizes were calculated to estimate the magnitude of change in HRQoL that can be associated with TPM therapy.
Results: TPM 100 mg/d significantly improved all three MSQ domains compared with placebo for both the ITT (TPM, n = 372; placebo, n = 362) and study-completer (TPM, n = 220; placebo, n = 216) populations (P < .001 for all three domains, both populations). Effect sizes for TPM 100 mg/d varied from 0.40 to 0.78, indicating that the changes in MSQ scores for TPM 100 mg/d were moderate and may be clinically significant.
Conclusion: TPM 100 mg/d has been shown to be effective in the prevention of migraine headache in adults. As the MSQ results from the three randomized, placebo-controlled trials indicate, HRQoL is significantly improved for up to 6 months following initiation of treatment.