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The Impact of Topiramate on Health-Related Quality
of Life Indicators in Chronic Migraine
David W. Dodick, MD; Stephen Silberstein, MD;
Joel Saper, MD; Fred G. Freitag, MD; Roger K. Cady, MD;
Alan M. Rapoport, MD; Ninan T. Mathew, MD;
Joseph Hulihan, MD; Concetta Crivera, PharmD, MPH;
Marcia F.T. Rupnow, PhD; Lian Mao, MS;
Gary Finlayson RPh; Steven J Greenberg, MD
Posted: April 2008
Background: Chronic migraine is a disabling primary chronic daily disorder that significantly impacts the daily activities of patients with this disorder. To our knowledge, this is the first report of large, randomized, double-blind placebo-controlled trial that assessed the impact of topiramate on the daily activities, emotional distress, headache-related disability, and global impression of change in patients with chronic migraine.
Objective: To assess whether topiramate 100 mg/day reduces migraine-related disability and limitations of daily activities in patients with chronic migraine.
Study Design/Methods: Patients aged ≥ 18 years with chronic migraine were randomized 1:1 ratio to topiramate 100 mg/day or placebo. The double-blind period lasted 16 weeks. Three patient-reportes outcome measures were administered: Migraine Disability Assessment, Migraine-Specific Quality of Life Questionnaire (Domains: Role Function Restrictive and Preventive and Emotional Function), and Subjectís Global Impression of Change. Investigators completed a Physicianís Global Impression of Change for each patient. Subjectís Global Impression of Change and Physicianís Global Impression of Change were completed one time, at the end of the study, and measured on a 7-point scale. (1= very much improved to 7 = very much worse). The Migraine-Specific Quality of Life Questionnaire was analyzed using analysis of covariance (last observation carried forward) approach. Results were not adjusted for multiplicity.
Results: A total of 328 patients were randomized (topiramate, n = 165; placebo, n = 163), and 306 patients were included in the intent-to-treat population. Mean age was 38.2 years, and a majority of the patients were female (85.3%). Fifty-six percent of topiramate-treated patients vs 45% of placebo-treated patients reported a >50% improvement in baseline in Migraine Disability Assessment scores (P=.074). The Migraine-Specific Quality of Life Questionnaire analysis demonstrated significant improvements at week 4 in all 3 domains, and at weeks 8 and 16 in both Role Function-Restrictive and Emotional Function domains. (P<.05). Role Function-Preventive approached, but did not reach significance, at week 8 (P=.053).Seventy-five percent and 72% of topiramate-treated patients vs 61% and 59% of placebo-treated patients reported improvements on the Subject and Physicianís Global Impression of Change scales (P=.025 and P=.037 respectively).
Conclusion: Compared with placebo-treated patients, topiramate 100/mg day appears to contribute to reductions in migraine-related limitations on daily activities and emotional distress beginning as early as week 4 and continuing up to week 16 after treatment. Physicianís Global Impression of Change results are very similar with Subjectís Global Impression of Change , indicating concordance between the physicianís and the subjectís assessments of improvement.