% 0期刊文章%欧根Trinka % Meriem Bensalem-Owen %托德·格林奈尔%大卫·坎图%一个琼娜Moreira琼娜夫人% %海龙程%大卫布卢姆% T钠和甲状腺激素水平在三期试验的辅助Eslicarbazepine醋酸(ESL),根据伴随抗癫痫药物(AED)使用(P5.271) % D J神经病学2018% % P P5.271 % V 90% N 15补充% X目的:评估钠和甲状腺激素水平变化与辅助ESL治疗期间,根据伴随AED使用。首页背景:英语每日一口头AED对部分性癫痫(POS)(焦)。降低血浆钠,血清游离甲状腺素(FT4),和自由三碘甲状腺氨酸(发生)已报告的病人采取ESL,并可能受到相伴AED使用。设计/方法:数据从三个双盲,三期试验的ESL (bia - 2093 - 301、-302和-304)集中。8周后基线,成人≥4 POS /月,服用1 - 3 aed,同样被随机安慰剂(n = 426)或ESL (n = 1021);帷幕,滴定,12周的维护。血浆和血清钠发生/ FT4使用集中进行安全分析人口(所有病人≥1剂量的研究药物),分层伴随AED使用(卡马西平、拉莫三嗪、丙戊酸、levetiracetam)。最低post-dose钠含量≤125毫克当量/ L,或减少> 10毫克当量/ L,被认为是具有临床意义。结果:超过70%的1447患者服用≥2基线aed。意味着钠水平变化没有临床意义(≤1.2毫克当量/ L在每个AED子群)。患者的比例> 10毫克当量/ L减少或最低post-dose钠含量≤125毫克当量/ L高ESL(分别为4.3 -7.1%和0 - 1.4%)比安慰剂(0 - 1.5%和0),无论AED使用。血清发生更大的变化从基线水平发生在ESL (−20.75−5.65 pg / dL)和安慰剂(−1.20到3.79 pg / dL);减少英语更明显患者服用伴随levetiracetam (−20.75 pg / dL)和拉莫三嗪(−18.72 pg / dL),比卡马西平(−8.50 pg / dL)和丙戊酸(−5.65 pg / dL)。 Mean changes in serum FT4 levels from baseline were small (≤0.1ng/dL) in all subgroups.Conclusions: Clinically meaningful post-dose sodium levels/reductions were more frequent with ESL than placebo, irrespective of concomitant AED use. Reductions in FT3 were greater with ESL than placebo; greater reductions occurred in the presence of lamotrigine and levetiracetam than carbamazepine and valproic acid.Study Supported by:BIAL and Sunovion Pharmaceuticals Inc.Disclosure: Dr. Trinka has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with UCB, Eisai, Novartis, Gerrot-Lannach, BIAL, Takeda, Biogen, Newbridge, Sunovion. Dr. Bensalem Owen has nothing to disclose. Dr. Grinnell has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. Dr. Cantu has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. Dr. Graça has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: BIAL - Portela & Ca, S.A. Dr. Moreira has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with BIAL — Portela & Ca., S.A. Dr. Cheng has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. Dr. Blum has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. %U