A retrospective, multicentre study of perampanel given as monotherapy in routine clinical care in people with epilepsy
A retrospective, multicentre study of perampanel given as monotherapy in routine clinical care in people with epilepsy
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DOI：
10.1016/j.seizure.2017.10.015
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发表时间：
2018-01-01
影响因子：
3
通讯作者：
Laurenz, Antonio
中科院分区：
文献类型：
--
作者：
Gil-Nagel, Antonio;Burd, Sergey;Laurenz, Antonio
目的：Perampanel已获批用于连续治疗局灶性癫痫发作（伴或不伴继发性全身性癫痫发作）和≥ 12岁癫痫患者的原发性全身性强直阵挛性癫痫发作。Perampanel最近在美国获批用于部分性癫痫发作的单药治疗。本研究提供了perampanel单药治疗在现实环境中的可行性。方法：本回顾性、非干预性、多中心研究（NCT 02736162）于2013年1月至2016年3月在欧洲和俄罗斯的癫痫专科中心进行。符合条件的个体被诊断为癫痫，并接受perampanel主要或次要单药治疗作为常规临床护理。主要终点是从perampanel连续治疗转换后，在3、6、12、18和24个月时，仍接受perampanel单药治疗的个体比例（留存率）。
Purpose: Perampanel is approved for adjunctive treatment of focal seizures, with or without secondarily generalised seizures, and for primary generalised tonic-clonic seizures in people with epilepsy aged >= 12 years. Perampanel was recently approved for monotherapy use for partial seizures in the United States. This study provides insight into the feasibility of perampanel monotherapy in real-world settings.Methods: This retrospective, non-interventional, multicentre study (NCT02736162) was conducted between January 2013 and March 2016 in specialist epilepsy centres in Europe and Russia. Eligible individuals had a diagnosis of epilepsy and received perampanel primary or secondary monotherapy as routine clinical care. The primary endpoint was proportion of individuals remaining on perampanel monotherapy, after conversion from perampanel adjunctive treatment, at 3, 6, 12, 18 and 24 months (retention rate).Results: Sixty individuals were in the safety set (female, 63%; white, 97%; aged 18 to