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To purchase or authenticate to the full-text of this article, please visit this link: http://dx.doi.org/10.1111/j.1468-2982.2007.01326.x Byline: H-C Diener (1), G Bussone (2), JC Van Oene (3), M Lahaye (3), S Schwalen (3), PJ Goadsby (45) Keywords: Chronic migraine treatment; topiramate; placebo; randomised trial Abstract: Diener H-C, Bussone G, Van Oene JC, Lahaye M, Schwalen S & Goadsby PJ on behalf of the TOPMAT-MIG-201(TOP-CHROME) Study Group. Topiramate reduces headache days in chronic migraine: a randomized, double-blind, placebo-controlled study. Cephalalgia 2007; 27:814-823. London. ISSN 0333-1024 The aim of this study was to evaluate the efficacy and tolerability of topiramate for the prevention of chronic migraine in a randomized, double-blind, placebo-controlled trial. Chronic migraine is a common form of disabling headache presenting in headache subspecialty practice. Preventive treatments are essential for chronic migraine management, although there are few or no controlled empirical trial data on their use in this patient population. Topiramate is approved for the prophylaxis of migraine headache in adults. Patients (18-65 years) who experienced chronic migraine (defined as [greater than or equal to]15 monthly migraine days) for [greater than or equal to]3 months prior to trial entry and had [greater than or equal to]12 migraine days during the 4-week (28-day) baseline phase were randomized to topiramate or placebo for a 16-week, double-blind trial. Topiramate was titrated (25 mg weekly) to a target dose of 100 mg/day, allowing dosing flexibility from 50 to 200 mg/day, according to patient need. Existing migraine preventive treatments, except for antiepileptic drugs, were continued throughout the trial. The primary efficacy measure was the change in number of migraine days from the 28-day baseline phase to the last 28 days of the double-blind phase in the intent-to-treat population, which consisted of all patients who received at least one dose of study medication and had one outcome assessment during the double-blind phase. Health-related quality of life was evaluated with the Migraine Specific Quality of Life Questionnaire (MSQ, Version 2.1), the Headache Impact Test (HIT-6) and the Migraine Disability Assessment (MIDAS) questionnaires, and tolerability was assessed by adverse event (AE) reports and early trial discontinuations. Eighty-two patients were screened. Thirty-two patients in the intent-to-treat population (mean age 46 years; 75% female) received topiramate (mean modal dose [+ or -] SD = 100 [+ or -] 17 mg/day) and 27 patients received placebo. Mean ([+ or -]SD) baseline number of migraine days per 4 weeks was 15.5 [+ or -] 4.6 in the topiramate group and 16.4 [+ or -] 4.4 in the placebo group. Most patients (78%) met the definition for acute medication overuse at baseline. The mean duration of treatment was 100 and 92 days for topiramate- and placebo-treated patients, respectively. Study completion rates for topiramate- and placebo-treated patients were 75% and 52%, respectively. Topiramate significantly reduced the mean number of monthly migraine days ([+ or -]SD) by 3.5 [+ or -] 6.3, compared with placebo (-0.2 [+ or -] 4.7, P < 0.05).No significant intergroup differences were found for MSQ and HIT-6. MIDAS showed improvement with the topiramate treatment group (P = 0.042 vs. placebo). Treatment emergent adverse events were reported by 75% of topiramate-treated patients (37%, placebo). The most common AEs, paraesthesia, nausea, dizziness, dyspepsia, fatigue, anorexia and disturbance in attention, were reported by 53%, 9%, 6%, 6%, 6%, 6% and 6% of topiramate-treated patients, respectively, vs. 7%, 0%, 0%, 0%, 0%, 4% and 4% of placebo-treated patients. This randomized, double-blind, placebo-controlled trial demonstrates that topiramate is effective and reasonably well tolerated when used for the preventive treatment of chronic migraine, even in the presence of medication overuse. Author Affiliation: (1)Department of Neurology, University of Duisburg-Essen, Germany, (2)Department of Neurology, 'C. Besta' Neurological Institute, Milan, Italy, (3)Janssen-Cilag EMEA, Tilburg, the Netherlands and Neuss, Germany, (4)Institute of Neurology, London, UK and (5)Department of Neurology, University of California, San Francisco, CA, USA Article History: Received 16 September 2006, accepted 15 January 2007 Article note: Professor P. J. Goadsby, Institute of Neurology, Queen Square, London WC1N 3BG, UK. Tel. + 44 20 7829 8749, fax + 44 20 7813 0349, e-mail peterg@ion.ucl.ac.uk