BACKGROUND Perampanel (PER) is a novel antiepileptic drug approved as an add-on therapy for focal onset seizures with or without generalization and primary generalized tonic-clonic seizures. Aim of this study was to evaluate PER efficacy and tolerability as add-on therapy in patients with drug-resistant focal onset seizures and especially temporal lobe epilepsy (TLE). METHODS An observational, prospective, multicentre study on adult with drug-resistant focal epilepsy consecutively recruited from six Italian tertiary epilepsy centres. All patients received add-on PER according to indication and clinical judgement. Seizure frequency and adverse events (AEs) were recorded at 6 and 12 months after PER introduction. RESULTS Study sample comprised 246 patients, 77 of which with TLE. Seventy-five (35.9%) out of 209 and 66 (38.8%) out of 170 patients still taking PER resulted to be responders (i.e. ≥50% of seizure frequency or seizure free) after six and 12 months, respectively. In the TLE group, 39 (57.3%) out of 68 subjects on PER after 6 months and 32 (60.4%) out of 53 subjects taking PER after 12 months were responders. Overall reported incidence of AEs was 26.1%. In 28 cases (11.3%) AEs lead/contributed to PER discontinuation. The most frequently reported AE were dizziness (14/84) and somnolence (14/84). Regarding TLE patients, 25.9% of them experienced at least one AE and discontinuation for AEs occurred in eight (10.4%). CONCLUSIONS This study confirmed the good efficacy and safety of PER for drug-resistant focal epilepsy in real-life conditions and, above all, for the first time provide its effectiveness in patients with TLE.

中文翻译：

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吡仑帕奈作为“真实世界”背景下耐药局灶性癫痫辅助治疗的疗效：关注颞叶癫痫

背景 Perampanel (PER) 是一种新型抗癫痫药物，被批准作为局灶性发作的附加疗法，用于伴有或不伴有全身性发作和原发性全身性强直阵挛发作。本研究的目的是评估 PER 作为附加疗法对耐药性局灶性癫痫发作，尤其是颞叶癫痫 (TLE) 患者的疗效和耐受性。方法 从六个意大利三级癫痫中心连续招募成人耐药局灶性癫痫患者的观察性、前瞻性、多中心研究。所有患者根据适应症和临床判断接受附加 PER。在 PER 引入后 6 个月和 12 个月记录癫痫发作频率和不良事件 (AE)。结果 研究样本包括 246 名患者，其中 77 名患有 TLE。209 和 66 (38.9%) 中的 75 (35.9%) 8%) 在 170 名仍在服用 PER 的患者中，分别在 6 个月和 12 个月后成为反应者（即≥50% 的癫痫发作频率或无癫痫发作）。在 TLE 组中，6 个月后接受 PER 的 68 名受试者中有 39 名 (57.3%) 和 12 个月后接受 PER 的 53 名受试者中有 32 (60.4%) 名有反应。报告的 AE 总体发生率为 26.1%。在 28 例 (11.3%) AE 中，导致/促成 PER 停药。最常报告的 AE 是头晕 (14/84) 和嗜睡 (14/84)。对于 TLE 患者，25.9% 的患者经历了至少 1 次 AE，8 次（10.4%）发生了 AE 停药。结论 本研究证实了 PER 在现实生活条件下治疗耐药性局灶性癫痫的良好疗效和安全性，最重要的是，首次证明了其对 TLE 患者的有效性。