% 0期刊文章%大卫弗朗茨% Zuhal Yapici约翰·劳森% %一个宽子Ikeda % Tilman垫状%裂缝Nabbout %一个Petrus de Vries保罗Curatolo % %一个丹尼斯Dlugos % Bijoyesh Mookerjee %詹娜的粉丝%安东尼娅Ridolfi % Fabian Herbst %杰奎琳法国% T Everolimus基于之前的临床疗效和安全性和伴随的抗癫痫药物患者的结节性硬化症(TSC)复杂关联难以发作:第三阶段的Subanalysis EXIST-3神经学研究(S9.007) % D J 2018% % P S9.007 % V 90% N % X 15补充目的:这Subanalysis EXIST-3 (NCT01713946)的有效性和安全性评估Everolimus基于病人之前和伴随的抗癫痫药物(aed)。首页背景:在EXIST-3 everolimus患者表现出显著的疗效和耐受性TSC-associated难以发作。然而,之前的影响或并发aed辅助everolimus的疗效和安全性,CYP3A4衬底,是未知的。设计/方法:TSC和难以发作,患者接受稳定剂量的1 - 3 aed都包括在内。18-week核心阶段后,患者可以进入扩展阶段和接收everolimus至ng / mL。疗效参数包括中值百分比减少从基线(PR)发作频率(SF)和反应率(RR;减少≥50%)。结果:361/366随机患者接受≥1剂量everolimus核心或扩展阶段。患者中1、2和3伴随aed,公关中值科幻(星期18 [n] / 1年[n])[38] 44.1% / 49.7%[32],[109][139] / 53.7%, 34.7%和27.7%[168][144]/ 40.3%,而中位数RRs 42.1% / 50.0%, 30.9% / 52.3% / 42.4%和29.8%,分别。失败的患者中0 - 4、5 - 7和> 7之前aed,公关在科幻小说中值40.0%[115][104]/ 51.5%,35.7%[109],[134]/ 54.1%和16.3%[103][85]/ 34.0%,而RRs 38.3% / 51.9%, 35.1%或51.4%,和17.5% / 34.1%。RRs似乎高患者伴随的奥卡西平(37.5%[48]/[37]54.1%),和氨己烯酸(37.5% [112][99]/ 52.5%)。没有明显差异的观察性口炎伴随aed数量/类型,但发热的发生率,肺炎、上呼吸道感染和腹泻似乎与伴随的aed的数量增加。结论:治疗everolimus导致改善公关在科幻和RR无论之前或同时aed的数量和类型。更好的反应everolimus aed之前减少了病人中观察到。一些AEs的发病率增加的数量和类型伴随aed或之前aed失败的数量。 Limitations: AED type was considered whether administered alone/in combination; investigators could change dose/number of AEDs during extension phase.Study Supported by:Novartis Pharmaceuticals CorporationDisclosure: Dr. Franz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis. Dr. Franz has received research support from Novartis. Dr. Lawson has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis. Dr. Lawson has received research support from Novartis. Dr. Yapici has nothing to disclose. Dr. Ikeda has nothing to disclose. Dr. Polster has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis, Desitin, UCB Pharma, Desitin, Zogenix. Dr. Nabbout has nothing to disclose. Dr. Curatolo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai, Shire, Novartis. Dr. de Vries has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis. Dr. de Vries has received research support from Novartis. Dr Dlugos has nothing to disclose. Dr. Mookerjee has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis. Dr. Fan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis. Dr. Ridolfi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis. Dr. Herbst has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis. Dr. French has received research support from Acorda, Alexza, Eisai Medical Research, LCGH, Lundbeck, Pfizer, SK Life Sciences, Sunovion, Takeda, and UCB. %U