Department of Neurology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Department of Neurology, Kosin University Gospel Hospital, University of Kosin College of Medicine, Busan, Republic of Korea.
Epilepsy Behav. 2023 Aug;145:109291. doi: 10.1016/j.yebeh.2023.109291. Epub 2023 Jun 17.
To assess the effectiveness and tolerability of perampanel monotherapy following conversion from adjunctive therapy.
This was a multicenter, retrospective, non-interventional study of Korean patients aged ≥12 years with focal-onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures. Data were extracted from electronic medical records of perampanel-treated patients from 1 February 2016 to 31 October 2020. Kaplan-Meier estimated retention rates, effectiveness, and safety were recorded.
Subjects (n = 66, mean age 46.2 years) were mostly male (68.2%) with focal to bilateral tonic-clonic seizure (71.2%). Mean duration of illness was 86.3 months. Retention rates after conversion to perampanel monotherapy at 3, 6, and 12 months (primary outcome) were 96.0%, 96.0%, and 75.6%, respectively. Overall retention rates in patients receiving perampanel as adjunctive or monotherapy at 3, 6, 12, 18, and 24 months after perampanel add-on were 100%, 98.3%, 95.9%, 92.6%, and 92.6%, respectively. Mean retention duration was 41.2 months (overall perampanel administration) and 21.4 months (monotherapy). Mean seizure frequency/28 days in the Full Analysis Set (n = 61) was comparable for adjunctive and monotherapy (0.2 ± 0.79 vs 0.2 ± 0.64; change between adjunctive and monotherapy periods: 0.0 ± 0.59; p = 0.498). Perampanel was well tolerated and no new safety signals were identified. Dizziness (4.6%), only reported during adjunctive therapy, was the most common treatment-emergent adverse event.
Conversion to perampanel monotherapy from adjunctive therapy showed promising results in subjects with FOS with/without focal to bilateral tonic-clonic seizures; further studies in a larger population are needed to confirm these encouraging data.
评估从辅助治疗转为普瑞巴林单药治疗的疗效和耐受性。
这是一项多中心、回顾性、非干预性研究，纳入年龄≥12 岁、有局灶性发作（FOS）伴或不伴局灶性到全面性强直-阵挛发作（FOS-TCS）的韩国患者。从 2016 年 2 月 1 日至 2020 年 10 月 31 日，从接受普瑞巴林治疗的患者的电子病历中提取数据。记录 Kaplan-Meier 估计的保留率、有效性和安全性。
受试者（n=66，平均年龄 46.2 岁）主要为男性（68.2%），伴有 FOS-TCS（71.2%）。平均病程为 86.3 个月。转为普瑞巴林单药治疗后 3、6 和 12 个月（主要结局）的保留率分别为 96.0%、96.0%和 75.6%。在接受普瑞巴林辅助或单药治疗的患者中，在转为普瑞巴林辅助治疗后 3、6、12、18 和 24 个月的总体保留率分别为 100%、98.3%、95.9%、92.6%和 92.6%。普瑞巴林总体治疗时长为 41.2 个月（普瑞巴林辅助治疗）和 21.4 个月（单药治疗）。全分析集（n=61）的平均癫痫发作频率/28 天在辅助治疗和单药治疗之间无差异（0.2±0.79 与 0.2±0.64；辅助治疗期与单药治疗期之间的变化：0.0±0.59；p=0.498）。普瑞巴林耐受良好，未发现新的安全性信号。头晕（4.6%），仅在辅助治疗期间报告，是最常见的治疗后出现的不良事件。
从辅助治疗转为普瑞巴林单药治疗对有 FOS 伴或不伴 FOS-TCS 的患者显示出良好的疗效；需要在更大的人群中开展进一步的研究来证实这些令人鼓舞的数据。
