文摘
摘要目的:评估新诊断患者的脂质变化成人focal-onset癫痫(FOS)提交在双盲治疗(DB)研究eslicarbazepine醋酸(ESL)或控释卡马西平(CBZ-CR)单药治疗,2年之后开放的扩展(OLE)学习英语。
背景:由于强有力的enzyme-induction,卡马西平可能导致脂质参数的变化1
设计/方法:因果分析184年新诊断成人从第三阶段的安全系数,随机、DB, active-controlled non-inferiority研究比较ESL (n = 96)与CBZ-CR 26周的时期(n = 88)。病人完成这项研究持续到2年OLE,所有收到的ESL(800 - 1600毫克/天)。实验室参数评估之前和之后ESL和CBZ-CR总胆固醇(TC)、低(低密度脂蛋白)、高(HDL)密度脂蛋白和甘油三酯。在治疗手臂假定值使用多重比较(p)与严格的α水平(0.027)2。
结果:CBZ-CR患者比例高3低密度脂蛋白和TC显著增加的DB, 11.54% (p = 0.0124)和14.94% (p = 0.0008),分别与基线相比。ESL患者显示没有变化的低密度脂蛋白和TC增加6.52% (p = 0.1088)。的患者比例高LDL和TC从CBZ-CR转向ESL显示显著减少,−11.11% (p = 0.0209)和−15.28% (p = 0.0076),分别。病人继续ESL OLE没有相关变化(McNemar检验法测试)。
DB,年底的患者比例高LDL和治疗之间TC水平低ESL (−12.31%, p = 0.061−13.64%, p = 0.037)比例差异。治疗观察基线之间没有显著差异(费雪的测试)。
高密度脂蛋白和甘油三酯没有决定性的变化。
程序分析不同时使用他汀类药物的患者显示出类似的结果。
结论:这个因果分析与新诊断成人患者安全系数,与文献一致4、5,显示低密度脂蛋白的增加和TC水平CBZ-CR和最小的ESL单一治疗后的长期效果。从CBZ-CR转向ESL显示改善TC和LDL,表明ESL高胆固醇血症患者可能是一种选择。
披露:尤金Trinka受到个人薪酬在500 - 4999美元的范围为UCB担任顾问。尤金Trinka已收到个人薪酬在500 - 4999美元的范围为卫材担任顾问。尤金Trinka已收到个人薪酬在500 - 4999美元的范围比亚尔担任顾问。尤金Trinka已收到个人薪酬在500 - 4999美元的范围为Bohringer殷格翰集团担任顾问。尤金Trinka已收到个人薪酬在500 - 4999美元的范围为美敦力公司担任顾问。尤金Trinka已收到个人薪酬在500 - 4999美元的范围为Everpharma担任顾问。尤金Trinka已收到个人薪酬在500 - 4999美元的范围为葛兰素史克公司担任顾问。尤金Trinka已收到个人薪酬在500 - 4999美元的范围作为顾问生原体。尤金Trinka已收到个人薪酬在500 - 4999美元的范围为武田担任顾问。尤金Trinka已收到个人薪酬在500 - 4999美元的范围为Liva-Nova担任顾问。 Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Newbridge. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GW Pharmaceuticals. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Marinus. The institution of Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Arvelle. Eugen Trinka has received research support from Austrian Science Fund (FWF). Eugen Trinka has received research support from Österreichische Nationalbank. Eugen Trinka has received research support from European Union. Eugen Trinka has received research support from GSK. Eugen Trinka has received research support from Biogen. Eugen Trinka has received research support from Eisai. Eugen Trinka has received research support from Novartis. Eugen Trinka has received research support from Red Bull. Eugen Trinka has received research support from Bayer. Eugen Trinka has received research support from UCB. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a other with Neuroconsult Ges.m.b.H.. RODRIGO ROCAMORA has nothing to disclose. Joana Moreira has received personal compensation for serving as an employee of BIAL. Ana Pereira has received personal compensation for serving as an employee of BIAL, Portela & Cª S.A.. Miguel Fonseca has received personal compensation for serving as an employee of Bial – Portela & Cª, S.A. The institution of Miguel Fonseca has received research support from Portuguese Foundation for Science and Technology. Guillermo Castilla Fernandez has received personal compensation for serving as an employee of Bial – Portela & Cª, S.A., Coronado, Portugal. Fabio Ikedo has received personal compensation for serving as an employee of Bial.
