@article {FrenchS56.006作者={杰奎琳法国和埃丽诺Ben-Menachem马丁·布罗迪和大卫Squillacote Haichen杨和迪Kumar和安东尼奥Laurenza}, title ={疗效的辅助Perampanel III期临床试验:Subanalysis发作频率和应答率的变化伴随的抗癫痫药物使用(S56.006)},体积={78}={1}补充数量,页面= {S56.006——S56.006} ={2012},出版商= {Wolters Kluwer健康,公司代表美国神经病学学会},文摘={目的:评估的影响伴随抗癫痫药物(aed)发作频率和应答率汇集分析Perampanel III期研究。首页背景III期试验中,辅助perampanel是有效的减少不可控部分性癫痫(4 - 12毫克/天)。设计/方法:基线后,患者(> = 12年,接收1 - 3 aed)是每日一次随机双盲治疗与安慰剂或perampanel 2, 4, 8日或12毫克。疗效端点进行分析对伴随使用最频繁的aed(任意组合)来测试与其他机制的行动如果添加这些aed perampanel的疗效的影响。端点是:分析癫痫发作频率变化百分比/ 28天(双盲和基线阶段)和50 \ %应答率(维护、基线)。结果:在第三阶段的研究中,1478名患者被随机分配和治疗(安慰剂,n = 441;perampanel 2毫克,n = 180;4毫克,n = 172;8毫克,n = 431;12毫克,n = 254),平均2.2伴随aed。最常见的aed患者(> = 45 /治疗组),用于1 - 3伴随aed的组合,包括:卡马西平(n = 491),丙戊酸钠(n = 478)、拉莫三嗪(n = 457)、和levetiracetam (n = 435)。中位数差异(Hodges-Lehmann)发作频率变化百分比/ 28天中值患者伴随的AED组合包括卡马西平、丙戊酸钠,拉莫三嗪,或levetiracetam与安慰剂比较包括:7.7 \ -7.8 \ % perampanel 2毫克%; -3.0\% to -12.7\% with 4 mg; -8.9\% to -20.8\% with 8 mg; and -12.4\% to -16.7\% with 12 mg. Responder rate ranges for these patients were: 13.6-23.1\% with placebo; 13.8-21.4\% with perampanel 2 mg; 19.6-34.7\% with 4 mg; 29.7-38.3\% with 8 mg; and 30.6-43.0\% with 12 mg.Conclusions: Perampanel (4-12 mg/day) decreased seizure frequency and increased responder rates in patients concomitantly taking at least one of the four most common AEDs. The presence of another AED mechanism did not appear to reduce the efficacy of perampanel.Supported by: Eisai Inc.Disclosure: Dr. French has nothing to disclose. Dr. Ben-Menachem has received personal compensation for activities with Eisai Inc, UCB Pharma, Cyberonics, Inc., GlaxoSmithKline, Inc. and Lundbeck Research USA as an advisory board participant and/or speaker. Dr. Ben-Menachem has received personal compensation in an editorial capacity for Acta Neurologica Scandinovica. Dr. Ben-Menachem has received research support from Eisai Inc, UCB Pharma and Bial. Dr. Brodie has received personal compensation for activities with Pfizer Inc, UCB Pharma, Eisai Inc., GlaxoSmithKline, Inc., Sanofi-Aventis Pharmaceuticals, Inc., and Lundbeck Research USA, Inc. Dr. Brodie has received research support from Eisai Inc. Dr. Squillacote has received personal compensation for activities with Eisai as an employee. Dr. Yang has received personal compensation for activities with Eisai, Inc. as an employee. Dr. Kumar has received personal compensation for activities with Eisai Inc. as an employee. Dr. Laurenza has received personal compensation for activities with Eisai as an employee.Thursday, April 26 2012, 15:00 pm-16:30 pm}, issn = {0028-3878}, URL = {//www.ez-admanager.com/content/78/1_Supplement/S56.006}, eprint = {//www.ez-admanager.com/content}, journal = {Neurology} }