TY - T1的辅助使用Ezogabine / Retigabine与传统的钠离子通道阻滞剂或Non-Sodium通道阻滞剂抗癫痫药物安全性和耐受性评价(P06.098) JF -神经学乔-神经病学SP - P06.098 LP - P06.098六世- 78 - 1补充AU -杰奎琳法国非盟-马丁·布罗迪盟苏珊麦当劳AU -安德鲁·斯科特AU -布莱恩•亚当斯盟Virinder诺瑞亚盟——莎拉DeRoss首页ett Y1 - 2012/04/26 UR - //www.ez-admanager.com/content/78/1_Supplement/P06.098.abstract N2 -目的:评估的安全性和耐受性Ezogabine / Retigabine (EZG /轮胎式龙门吊)作为辅助疗法与传统的钠离子通道阻滞剂(NaB)或non-NaB抗癫痫药物(aed)。背景EZG /轮胎式龙门吊(600 - 1200毫克/天)是有效和普遍容忍作为辅助治疗成人患者部分性癫痫发作。设计/方法:数据集从三个关键试验(研究205、301 (NCT00232596),和302年[NCT00235755])是集成和科目分为群体只采取传统的小伙子或只有non-NaBs辅助EZG /轮胎式龙门吊。安全性和耐受性措施包括治疗诱发不良事件(AEs),严重的AEs(节约)和AEs导致撤军。提出了结合数据对所有剂量由于小数量的受试者在每个剂量组。结果:1240例,344例(28%)在一个或多个小伙子只和196年(16%)在一个或多个non-NaBs。基线特征、人口特征和中位数EZG /轮胎式龙门吊剂量(900毫克/天)是相似的两个群体。耐受性普遍相似的群体之间。AEs发生在72%(安慰剂)和81% (EZG /轮胎式龙门吊)科目的家伙vs 81%和85%,分别与non-NaBs。节约被报道为7%(安慰剂)和9% (EZG /轮胎式龙门吊)科目的家伙vs 3%和9%,分别与non-NaBs。AEs导致戒断症状发生在9%(安慰剂)和24% (EZG /轮胎式龙门吊)科目的家伙vs 13%和30%,分别与non-NaBs。 Blurred vision occurred in 2% (placebo) and 7% (EZG/RTG) of subjects in the NaB group vs 1% and 4%, respectively, in the non-NaB group; tremor occurred in 2% (placebo) and 9% (EZG/RTG) of subjects in the NaB group vs 5% and 5%, respectively, in the non-NaB group. Fatigue was reported for 7% (placebo) and 16% (EZG/RTG) of subjects taking NaBs vs 3% and 17%, respectively, with non-NaBs.Conclusions: Safety and tolerability of EZG/RTG were generally similar as adjunctive therapy with only traditional NaB or only non-NaB AEDs.Supported by: Valeant Pharmaceuticals International and GlaxoSmithKline.Disclosure: Dr. French has nothing to disclose. 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. Ms. McDonald has received personal compensation for activities with GlaxoSmithKline as an employee. Ms. McDonald holds stock and/or stock options inGlaxoSmithKline. Dr. Scott has received personal compensation for activities with Valeant Pharmaceuticals and GlaxoSmithKline. Dr. Scott holds stock and/or stock options in GlaxoSmithKline. Dr. Adams has received personal compensation from GlaxoSmithKline as an employee. Dr. Nohria has received personal compensation for activities with Valeant Pharmaceuticals, GlaxoSmithKline, Inc., Marinus Pharma, and UCB Pharma. Dr. DeRossett has received personal compensation for activities with GlaxoSmithKline as an employee.Dr. DeRossett holds stock and/or stock options in GlaxoSmithKline.Thursday, April 26 2012, 07:30 am-12:00 pm ER -