Section of Epilepsy, Department of Neurology, Chang Gung Memorial Hospital, Linkou, Taiwan.
Section of Epilepsy, Department of Neurology, Chang Gung Memorial Hospital, Linkou, Taiwan; Institute of Molecular Medicine, National Tsing Hua University, Hsinchu, Taiwan.
Biomed J. 2017 Dec;40(6):347-354. doi: 10.1016/j.bj.2017.09.003. Epub 2018 Feb 3.
To analyze the efficacy and safety of perampanel over a 3-month period in a sample of Asian people with epilepsy.
The efficacy and safety of perampanel as an adjunctive therapy for patients with epilepsy were retrospectively reviewed and analyzed. Patients were categorized according to seizure type, concomitant antiepileptic drug usage, and perampanel dosage.
A total of 210 patients were included in the study and 131 patients completed 3 months of perampanel treatment. The average dosage of perampanel was 5.31 mg/day, and the 50% responder rate (≥50% seizure frequency reduction) in all patients was 45.8%, with a 27.5% seizure-free rate. For focal seizures, focal to bilateral tonic-clonic seizures, and primary generalized seizures, the 50% responder rates were respectively 29.4%, 49.5%, and 36.4%. In total, 39.5% of patients experienced adverse events within 3 months of observation period, and the rate of drug withdrawal due to adverse events was 8.6%. Dizziness, ataxia, irritability/aggression were the most common adverse events.
The efficacy and safety of perampanel in a real-world setting with Asian patients is comparable to that in clinical trials that have included fewer Asian patients.
分析亚洲癫痫患者样本中使用吡仑帕奈治疗 3 个月的疗效和安全性。
回顾性分析吡仑帕奈作为附加治疗癫痫患者的疗效和安全性。根据发作类型、合用抗癫痫药物和吡仑帕奈剂量对患者进行分类。
共有 210 例患者纳入研究,131 例患者完成了 3 个月的吡仑帕奈治疗。吡仑帕奈的平均剂量为 5.31mg/天,所有患者的 50%应答率(≥50%发作频率减少)为 45.8%,无发作率为 27.5%。对于局灶性发作、局灶性到双侧强直阵挛性发作和原发性全身性发作,50%应答率分别为 29.4%、49.5%和 36.4%。在观察期的 3 个月内,共有 39.5%的患者出现不良事件,因不良事件停药的比例为 8.6%。头晕、共济失调、烦躁/攻击性是最常见的不良事件。
吡仑帕奈在亚洲患者中的真实世界疗效和安全性与纳入亚洲患者较少的临床试验相当。