背景:评估抗癫痫药物治疗不同癫痫病因的有效性以优化个性化治疗方法非常重要。PERaMpanel汇总分析的有效性和耐受性(PERMIT)扩展研究的数据用于评估在临床实践中用于治疗具有一系列癫痫病因的个体时,perampanel(PER)的有效性和安全性/耐受性。
方法:对已知病因的个体的PERMIT延伸数据进行事后分析。在3、6和12个月后评估保留率。在3、6和12个月后以及最后一次访问(最后一次观察进行)时评估有效性。有效性评估包括应答率(癫痫发作频率降低≥50%)和癫痫发作自由率(至少自先前访问以来没有癫痫发作)。通过评估不良事件(AE)和导致停药的AE来评估安全性/耐受性。
结果:许可扩展包括1945名具有结构性病因的个体,1012与遗传病因,93例具有传染性病因,和26具有免疫病因。12个月时的保留率为61.1%(结构性),65.9%(遗传),56.8%(感染性)和56.5%(免疫性)。在最后一次访问中,应答率(总癫痫发作)为43.3%(结构性),68.3%(遗传),37.0%(感染性)和20.0%(免疫性),相应的癫痫发作自由率为15.8%,46.5%,11.1%和5.0%,分别。AE发生率为58.0%(结构性),46.5%(遗传),51.1%(感染性)和65.0%(免疫性),12个月以上不良事件导致的相应停药率为18.9%,16.4%,18.5%和21.7%,分别。报告的AE类型在病因亚组之间通常是一致的,没有特殊的AE出现。
结论:尽管在临床实践中用于治疗具有一系列癫痫病因的个体时,PER是有效的并且总体上耐受性良好,其有效性和耐受性在不同亚组之间的差异表明,PER可能对具有特定癫痫病因的个体特别有用.
BACKGROUND: It is important to assess the effectiveness of an antiseizure medication in treating different epilepsy aetiologies to optimise individualised therapeutic approaches. Data from the PERaMpanel pooled analysIs of effecTiveness and tolerability (PERMIT) Extension study were used to assess the effectiveness and safety/tolerability of perampanel (PER) when used to treat individuals with a range of epilepsy aetiologies in clinical practice.
METHODS: A post hoc analysis was conducted of PERMIT Extension data from individuals with a known aetiology. Retention was assessed after 3, 6 and 12 months. Effectiveness was assessed after 3, 6 and 12 months and at the last visit (last observation carried forward). Effectiveness assessments included responder rate (≥ 50% seizure frequency reduction) and seizure freedom rate (no seizures since at least the prior visit). Safety/tolerability was assessed by evaluating adverse events (AEs) and AEs leading to discontinuation.
RESULTS: PERMIT Extension included 1945 individuals with structural aetiology, 1012 with genetic aetiology, 93 with an infectious aetiology, and 26 with an immune aetiology. Retention rates at 12 months were 61.1% (structural), 65.9% (genetic), 56.8% (infectious) and 56.5% (immune). At the last visit, responder rates (total seizures) were 43.3% (structural), 68.3% (genetic), 37.0% (infectious) and 20.0% (immune), and corresponding seizure freedom rates were 15.8%, 46.5%, 11.1% and 5.0%, respectively. AE incidence rates were 58.0% (structural), 46.5% (genetic), 51.1% (infectious) and 65.0% (immune), and corresponding rates of discontinuation due to AEs over 12 months were 18.9%, 16.4%, 18.5% and 21.7%, respectively. The types of AEs reported were generally consistent across aetiology subgroups, with no idiosyncratic AEs emerging.
CONCLUSIONS: Although PER was effective and generally well tolerated when used to treat individuals with a range of epilepsy aetiologies in clinical practice, variability in its effectiveness and tolerability across the subgroups indicates that PER may be particularly useful for individuals with specific epilepsy aetiologies.