K-L Lai1,2,3,4, D M Niddam5, J-L Fuh2,3, S-P Chen2,3, Y-F Wang2,3, W-T Chen2,3,5, J-C Wu4,6, S-J Wang2,3,5. 1. Department of Neurology, Taipei Municipal Gandau Hospital, Taipei, Taiwan. 2. Department of Neurology, Neurological Institute, Taipei Veterans General Hospital, Taipei, Taiwan. 3. Department of Neurology, School of Medicine, National Yang-Ming University, Taipei, Taiwan. 4. Institute of Clinical Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan. 5. Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan. 6. Division of Gastroenterology, Department of Internal Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
Abstract
OBJECTIVES:Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic options. This study explored the efficacy of 10 mg/d flunarizine for CM prophylaxis as compared with 50 mg/d topiramate. METHODS: We conducted a prospective, randomized, open-label, blinded-endpoint trial. Patients with CM were randomized to flunarizine and topiramate treatment. The primary outcomes assessed were the reductions in the total numbers of headache days and migraine days after 8 weeks of treatment. Secondary outcomes were reductions in the numbers of days of acute abortive medication intake and acute abortive medication tablets taken, and the 50% responder rate. RESULTS: Sixty-two subjects were randomized (n=31/group). Patients treated with flunarizine showed significant reductions in the numbers of total headache days (-4.9 vs -2.3, P=.012) and migraine days (-4.3 vs -1.4, P=.001) compared with those treated with topiramate. Patients treated with flunarizine also showed significant reductions in the numbers of days of acute abortive medication intake (-2.3 vs -0.2, P=.005) and acute abortive medication tablets taken (-4.6 vs -0.5, P=.005) and had a higher 50% responder rate in terms of total headache days (58.6% vs 25.9%, P=.013) and migraine days (75.9% vs 29.6%, P=.001), compared with topiramate-treated patients. Flunarizine was generally well tolerated and had a safety profile comparable to that of topiramate. CONCLUSIONS: Our results suggest that, in an 8-week study, 10 mg/d flunarizine is more effective than 50 mg/d topiramate for CM prophylaxis.
RCT Entities:
OBJECTIVES: Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic options. This study explored the efficacy of 10 mg/d flunarizine for CM prophylaxis as compared with 50 mg/d topiramate. METHODS: We conducted a prospective, randomized, open-label, blinded-endpoint trial. Patients with CM were randomized to flunarizine and topiramate treatment. The primary outcomes assessed were the reductions in the total numbers of headache days and migraine days after 8 weeks of treatment. Secondary outcomes were reductions in the numbers of days of acute abortive medication intake and acute abortive medication tablets taken, and the 50% responder rate. RESULTS: Sixty-two subjects were randomized (n=31/group). Patients treated with flunarizine showed significant reductions in the numbers of total headache days (-4.9 vs -2.3, P=.012) and migraine days (-4.3 vs -1.4, P=.001) compared with those treated with topiramate. Patients treated with flunarizine also showed significant reductions in the numbers of days of acute abortive medication intake (-2.3 vs -0.2, P=.005) and acute abortive medication tablets taken (-4.6 vs -0.5, P=.005) and had a higher 50% responder rate in terms of total headache days (58.6% vs 25.9%, P=.013) and migraine days (75.9% vs 29.6%, P=.001), compared with topiramate-treated patients. Flunarizine was generally well tolerated and had a safety profile comparable to that of topiramate. CONCLUSIONS: Our results suggest that, in an 8-week study, 10 mg/d flunarizine is more effective than 50 mg/d topiramate for CM prophylaxis.
Authors: J C A Edvinsson; A Viganò; A Alekseeva; E Alieva; R Arruda; C De Luca; N D'Ettore; I Frattale; M Kurnukhina; N Macerola; E Malenkova; M Maiorova; A Novikova; P Řehulka; V Rapaccini; O Roshchina; G Vanderschueren; L Zvaune; A P Andreou; K A Haanes Journal: J Headache Pain Date: 2020-06-05 Impact factor: 8.588