TY - T1的死亡率在第三阶段研究的辅助和单方Eslicarbazepine醋酸(ESL)患者部分性癫痫(POS) (P2.058) JF -神经学乔-神经学六世- 86 - 16补充SP - P2.058盟尤金Trinka AU -安德鲁·科尔盟Eva Andermann AU -海伦娜伽马盟-弗朗西斯科罗查AU -大卫·布卢首页姆AU -托德·格林奈尔盟海龙程盟- Philippe Ryvlin Y1 - 2016/04/05 UR - //www.ez-admanager.com/content/86/16_Supplement/P2.058.abstract N2 -目的:进行探索性分析成人死亡率与耐火POS对ESL第三阶段辅助或者单一疗法的研究。背景:在癫痫死亡率和不明原因猝死(癫痫)癫痫的重要问题。癫痫的危险因素并不是完全理解,但可能包括癫痫控制不足。方法:死亡率数据从六项研究包括:辅助研究,bia - 2093 - 301 / -302/-304(包括非盲(OL)扩展阶段);-045/-046,单一疗法的研究和相关的OL扩展,-050年。耐火材料POS患者(≥4发作/月)期间稳定≥1抗癫痫药物(AED)治疗收到辅助ESL(400毫克,800毫克和1200毫克每日一次(QD),加上稳定剂量的基线AED),或ESL单一疗法(1200毫克或1600 mg QD(研究-045年和-046年;先前的aed撤回),或800 - 2400 mg QD(研究-050;灵活剂量时间表,≤2额外non-oxcarbazepine aed允许])。结果:病人的数量≥1剂量的英语是:辅助试验,1021双盲;639 OL; monotherapy trials, 365 double-blind; 274 OL. As of 09/22/2014, overall ESL exposure (patient-years) was 1877.3 for adjunctive therapy and 627.0 for monotherapy (double-blind and OL periods combined), while a total of 19 deaths had occurred: two during pre-randomization; 13 during double-blind or OL treatment with placebo (n=2) or ESL (n=13); and four after ESL discontinuation. Six deaths were potentially due to SUDEP; three occurred while patients were taking ESL (adjunctive, n=2; monotherapy, n=1). SUDEP rates were 0.11 per 100 patient-years in patients taking adjunctive ESL (double-blind and OL phases) (upper 90[percnt] confidence limit [CL]=0.34) and 0.12 per 100 patient-years for those taking ESL as either monotherapy or adjunctive therapy (upper 90[percnt] CL=0.31). Conclusions: Deaths, including those potentially due to SUDEP, were rare among adults with refractory POS taking ESL (adjunctive or monotherapy) in Phase III studies. Study Supported by Sunovion Pharmaceuticals Inc.Disclosure: Dr. Trinka has received personal compensation for activities Eisai, Ever Neuropharma, Biogen Idec, Medtronics, Bial, GL Pharma, GlaxoSmithKline, Boehringer, Suniovion, Actavis and UCB. Dr. Cole has received personal compensation for activities with Clarus Ventures and Sage Therapeutics as a consultant. Dr. Andermann has nothing to disclose. Dr. Gama has received personal compensation for activities with BIAL. Dr. Rocha has received personal compensation for activities with Bial as an employee. Dr. Blum has received personal compensation for activities with Sunovion Pharmaceuticals Inc. as an employee. Dr. Grinnell has received personal compensation for activities with Sunovion Pharmaceuticals. Dr. Cheng has received personal compensation for activities with Sunovian Pharmaceuticals, Inc. Dr. Ryvlin has received personal compensation for activities with UCB Pharma.Sunday, April 17 2016, 8:30 am-5:30 pm ER -