Neurology Department, Hospital Reina Sofía, Córdoba, Spain.
Epilepsy Unit, Cruces University Hospital, Bilbao, Spain.
Epilepsy Behav. 2022 Sep;134:108777. doi: 10.1016/j.yebeh.2022.108777. Epub 2022 Jul 8.
In order to characterize the real-world effectiveness and safety of perampanel during clinical use in Europe, we conducted a structured literature search and scoping review of real-world studies conducted in Europe in adolescents (aged ≥ 12 years) or adults who were prescribed perampanel for focal epilepsy or primary generalized tonic-clonic seizures in the context of idiopathic generalized epilepsy, published between January 2016 and July 2021. We identified 29 relevant studies (20 retrospective and 9 prospective) in 3608 patients; median study duration was 12 months. Most patients (76.1%) were receiving two or more antiseizure drugs (ASDs) when perampanel was initiated. The maintenance perampanel dose ranged from 2 to 16 mg/day (most commonly 6 mg/day). Retention rate at 12 months ranged from 46% to 90.5% (median 71.1%). The proportion of patients who were free of seizures during perampanel ranged from 1.8% to 84.6%, but were consistently below 20% in studies where patients had received an average of ≥5 prior ASDs and above 20% where patients had received an average of <5 prior ASDs. The proportion of patients who achieved ≥50% reduction in seizures during perampanel ranged from 20.0% to 85.7%. Across all studies, the incidence of adverse events (AEs) ranged from 18.2% to 67.4% (median 37.1%) and discontinuation due to AEs from 6.2% to 56% (median 12.5%). Discontinuation rates tended to be higher in UK studies than in studies from Italy or Spain. The most commonly reported individual AEs were dizziness/vertigo (median incidence 13.7%), somnolence (median 11.9%), aggression (median 9.8%), irritability (median 9.1%), and cognitive deficits (median 7.0%). There was no relationship between the overall rate of AEs and perampanel dose, perampanel plasma levels, or number of concomitant medications. Our global overview of European observational studies with perampanel provides evidence that this agent is effective and safe in clinical practice in a range of countries, patients, and settings.
为了描述在欧洲临床应用中吡仑帕奈的真实世界疗效和安全性，我们对 2016 年 1 月至 2021 年 7 月期间在欧洲发表的、针对特发性全面性癫痫患者的局灶性癫痫或原发性全面性强直阵挛性发作，在背景为 ID 下处方吡仑帕奈的青少年（≥12 岁）或成人患者，开展了一项结构文献检索和范围综述，并纳入了真实世界研究。共纳入 3608 例患者的 29 项相关研究（20 项回顾性研究和 9 项前瞻性研究）；中位研究持续时间为 12 个月。大多数患者（76.1%）在起始使用吡仑帕奈时正在接受两种或更多种抗癫痫药物（AEDs）。维持剂量范围为 2-16mg/天（最常见的剂量为 6mg/天）。12 个月时的保留率为 46%-90.5%（中位数为 71.1%）。在吡仑帕奈治疗期间无癫痫发作的患者比例为 1.8%-84.6%，但在接受平均≥5 种既往 AEDs 的患者中始终低于 20%，在接受平均<5 种既往 AEDs 的患者中则高于 20%。在吡仑帕奈治疗期间癫痫发作减少≥50%的患者比例为 20.0%-85.7%。所有研究中，不良事件（AE）发生率为 18.2%-67.4%（中位数为 37.1%），因 AE 而停药的比例为 6.2%-56%（中位数为 12.5%）。英国研究中的停药率高于意大利或西班牙的研究。最常报告的个别 AE 是头晕/眩晕（发生率中位数为 13.7%）、嗜睡（中位数为 11.9%）、攻击行为（中位数为 9.8%）、易激惹（中位数为 9.1%）和认知障碍（中位数为 7.0%）。AE 的总体发生率与吡仑帕奈剂量、吡仑帕奈血浆水平或伴随药物数量之间无相关性。我们对欧洲吡仑帕奈观察性研究的全球综述提供了证据，表明该药物在一系列国家、患者和环境中具有有效性和安全性。
