A non-inferiority randomized controlled study of Perampanel versus Oxcarbazepine monotherapy for post-stroke epilepsy

IF 2.7 3区医学 Q2 CLINICAL NEUROLOGY

Seizure-European Journal of Epilepsy Pub Date : 2025-02-01 DOI:10.1016/j.seizure.2025.01.016

Cuihua Yan , Jing Liu , Jing Jiang , Yanping Sun , Juan Chen , Kunkun Wei , Xiaoyun Liu , Qi Xiang , Anru Liu , Yuxiang Han , Liling Yang , Tao Han , Xuewu Liu

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引用次数: 0

Abstract

Background

Post-stroke epilepsy (PSE) poses a significant challenge despite advances in stroke treatment. This study compares the efficacy of the novel anti-seizure medication (ASM) Perampanel with the classical ASM Oxcarbazepine in treating PSE.

Methods

This prospective randomized controlled trial recruited PSE patients from September 2022 to January 2024 across multiple hospitals. Patients were randomly assigned to receive either Perampanel or Oxcarbazepine monotherapy. Baseline seizure frequency was measured over three months prior to treatment. Efficacy was assessed at six months, with a ≥ 50 % reduction in seizure frequency deemed effective. Perampanel was considered non-inferior to Oxcarbazepine if its lower 95 % confidence limit for efficacy was above 80 % of Oxcarbazepine's six-month seizure freedom rate. Intention-to-treat analysis and Kaplan-Meier methods evaluated retention rates and side effects.

Results

A total of 67 patients were included in this study: 33 patients in the Perampanel group (26 males, 78.8 %; 7 females, 21.2 %) and 34 patients in the Oxcarbazepine group (26 males, 76.5 %; 8 females, 23.5 %). There were no statistically significant differences in the baseline data between the two groups. This indicates that the groups are comparable. Treatment efficacy was 75.0 % and 78.8 % in the Perampanel and Oxcarbazepine groups at three months, and 80.6 % and 75.0 % at six months, respectively. At six months, the lower limit of the 95 % confidence interval for efficacy in the Perampanel group was higher than the prespecified non-inferiority threshold, indicating that Perampanel was noninferior than Oxcarbazepine. The rates of drug retention and adverse effects were similar in the two groups, with no statistically significant difference (P > 0.05).

Conclusion

Perampanel is noninferior to Oxcarbazepine and is considered a good option for the management of post-stroke epilepsy.

查看原文本刊更多论文

Perampanel与奥卡西平单药治疗脑卒中后癫痫的非劣效性随机对照研究。

背景：脑卒中后癫痫（PSE）尽管在脑卒中治疗方面取得了进展，但仍面临着重大挑战。本研究比较了新型抗癫痫药物Perampanel与经典抗癫痫药物奥卡西平治疗PSE的疗效。方法：该前瞻性随机对照试验从2022年9月至2024年1月在多家医院招募PSE患者。患者被随机分配接受Perampanel或奥卡西平单药治疗。基线癫痫发作频率在治疗前三个月测量。6个月时评估疗效，癫痫发作频率降低≥50%被认为有效。如果Perampanel的95%置信下限高于奥卡西平6个月癫痫发作自由率的80%，则认为Perampanel不次于奥卡西平。意向治疗分析和Kaplan-Meier方法评估了保留率和副作用。结果：本研究共纳入67例患者：Perampanel组33例(男性26例，78.8%；女性7例（21.2%），奥卡西平组34例(男性26例，76.5%；8名女性，23.5%)。两组基线数据无统计学差异。这表明两组具有可比性。Perampanel组和奥卡西平组治疗3个月的疗效分别为75.0%和78.8%，6个月的疗效分别为80.6%和75.0%。6个月时，Perampanel组95%可信区间的下限高于预先设定的非劣效性阈值，表明Perampanel的疗效不劣于奥卡西平。两组药物潴留率及不良反应发生率相近，差异无统计学意义（P < 0.05）。结论：Perampanel的疗效优于奥卡西平，是治疗脑卒中后癫痫的良好选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Seizure-European Journal of Epilepsy 医学-临床神经学

CiteScore

5.60

自引率

6.70%

发文量

231

审稿时长

34 days

期刊介绍： Seizure - European Journal of Epilepsy is an international journal owned by Epilepsy Action (the largest member led epilepsy organisation in the UK). It provides a forum for papers on all topics related to epilepsy and seizure disorders.