PT期刊文章AU -斯科特·明茨盟杰奎琳法国非盟-贝特西·威廉姆斯盟安娜彭定康AU -安东尼奥Laurenza TI -外推的辅助疗效和安全性三期部分癫痫试验的数据来评估Perampanel作为单一疗法(P1.259) DP - 2018年4月10 TA -神经病学PG - P1.259 VI - 90 IP - 15补充4099 - //www.ez-admanager.com/content/90/15_Supplement/P1.259.short 4100 - //www.ez-admanager.com/content/90/15_Supplement/P1.首页259.full所以Neurology2018 4月10;90 AB -目的:评估perampanel作为单药治疗癫痫的辅助疗效和安全性数据推断的偏随机、双盲、安慰剂对照部分癫痫患者III期试验。背景:Perampanel被批准用于治疗局部癫痫,有/没有二级泛化和辅助治疗的原发性广义tonic-clonic发作癫痫患者年龄≥12年。FDA认为它可以推断数据辅助试验的抗癫痫药物(aed)单药治疗的设置;功效不应该依赖于一个特定的辅助AED机制,和不同的药物接触应该占。设计/方法:患者(≥12岁)耐火材料部分癫痫发作,有/没有二级泛化,接受安慰剂或辅助perampanel 12毫克/天,在这尊双盲阶段。平均发作频率变化百分比/ 28天,治疗诱发不良事件(TEAE)发生率进行分析根据作用机理(农业部)伴随AED,使用enzyme-inducing AED (EIAEDs), AED数量,最常见的AED。Perampanel我们关系是由伴随AED评估使用。结果:1480名患者治疗。人口结构是类似的跨子组(平均年龄33.5 - -45.3年;49.3 - -69.2%女性)。更大的平均百分比减少发作频率通常被观察到随着perampanel所有子组。 TEAE incidence was generally unaffected by AED MOA and number of baseline AEDs, but was higher with non-inducers than with EIAEDs. Across subgroups, the most common TEAE was dizziness. Pharmacokinetic/pharmacodynamic analyses showed percent change in seizure frequency and 50% responder rates were correlated with perampanel exposure.Conclusions: Perampanel was efficacious and well tolerated regardless of concomitant AED use, suggesting perampanel efficacy and safety are not dependent on the presence of any particular concomitant AED. Patients previously treated with EIAEDs may require dosage reduction, as EIAEDs lower perampanel exposure. Perampanel was recently approved for monotherapy use for partial seizures in the US, supported by this analysis.Study Supported by:Eisai Inc.Disclosure: Dr. Mintzer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai,UCB, Abbvie. Dr. Mintzer has received research support from UCB. Dr. French has received research support from Acorda, Alexza, Eisai Medical Research, LCGH, Lundbeck, Pfizer, SK Life Sciences, Sunovion, Takeda, and UCB. Dr. Williams has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc. Dr. Williams holds stock and/or stock options in Spouse is employee of Stryker Orthopedics. Dr. Williams has received research support from Employee of Eisai Inc. Dr. Patten has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai Ltd. Dr. Laurenza has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai employee.