Hospital Ruber Internacional, Calle de la Masó 38, 28034 Madrid, Spain.
Pirogov Russian National Research Medical University, Ostrovitianov Str. 1, Moscow, 117997, Russia.
Seizure. 2018 Jan;54:61-66. doi: 10.1016/j.seizure.2017.10.015. Epub 2017 Oct 18.
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.
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).
Sixty individuals were in the safety set (female, 63%; white, 97%; aged 18 to <65 years, 73%). Most (85%) received secondary monotherapy with perampanel. At study cut-off, 68% of individuals were continuing on perampanel monotherapy (secondary monotherapy: 55%). The median duration of retention was not calculable due to the high number of individuals ongoing on monotherapy. Twelve individuals had treatment-emergent adverse events that started during perampanel monotherapy, the most frequent was dizziness (5%). One serious treatment-emergent adverse event was reported (pneumonia during adjunctive perampanel treatment).
In this small retrospective study of individuals who received perampanel monotherapy, the majority maintained monotherapy. Perampanel monotherapy may be an achievable option in some people with epilepsy.
仑帕奈已获批准用于辅助治疗有或无继发全面性发作的局灶性发作，以及用于年龄≥12 岁的癫痫患者的原发性全面性强直-阵挛发作。仑帕奈最近在美国被批准用于部分性发作的单药治疗。本研究深入了解了仑帕奈在真实环境中单药治疗的可行性。
这是一项回顾性、非干预性、多中心研究（NCT02736162），于 2013 年 1 月至 2016 年 3 月在欧洲和俄罗斯的专门癫痫中心进行。符合条件的个体被诊断患有癫痫，并接受仑帕奈作为常规临床护理的一线或二线单药治疗。主要终点是在从仑帕奈辅助治疗转换后，3、6、12、18 和 24 个月时仍继续接受仑帕奈单药治疗的个体比例（保留率）。
60 名个体纳入安全性集（女性占 63%；白人占 97%；年龄 18 岁至<65 岁占 73%）。大多数（85%）接受仑帕奈的二线单药治疗。在研究截止时，68%的个体继续接受仑帕奈单药治疗（二线单药治疗：55%）。由于正在接受单药治疗的个体数量众多，因此无法计算中位保留时间。有 12 名个体发生了在仑帕奈单药治疗期间开始的治疗中出现的不良事件，最常见的是头晕（5%）。报告了 1 例严重的治疗中出现的不良事件（仑帕奈辅助治疗期间发生肺炎）。
在这项接受仑帕奈单药治疗的个体的小型回顾性研究中，大多数个体维持单药治疗。仑帕奈单药治疗可能是一些癫痫患者的可行选择。
