Gasparini Sara, Ferlazzo Edoardo, Neri Sabrina, Cianci Vittoria, Iudice Alfonso, Bisulli Francesca, Bonanni Paolo, Caggia Emanuele, D'Aniello Alfredo, Di Bonaventura Carlo, DiFrancesco Jacopo C, Domina Elisabetta, Dono Fedele, Gambardella Antonio, Marini Carla, Marrelli Alfonso, Matricardi Sara, Morano Alessandra, Paladin Francesco, Renna Rosaria, Striano Pasquale, Pascarella Angelo, Ascoli Michele, Aguglia Umberto
Department of Medical and Surgical Sciences, Magna Græcia University of Catanzaro, Catanzaro, Italy.
Regional Epilepsy Centre, Great Metropolitan "Bianchi-Melacrino-Morelli Hospital", Reggio Calabria, Italy.
Epilepsia Open. 2022 Dec;7(4):687-696. doi: 10.1002/epi4.12649. Epub 2022 Sep 22.
Perampanel (PER) is indicated as adjunctive antiseizure medication (ASM) in adolescents and adults with epilepsy. Data from clinical trials show good efficacy and tolerability, while limited information is available on the routine clinical use of PER, especially when used as only add-on treatment.
We performed an observational, retrospective, multicenter study on people with focal or generalized epilepsy aged >12 years, consecutively recruited from 52 Italian epilepsy centers. All patients received PER as the only add-on treatment to a background ASM according to standard clinical practice. Retention rate, seizure frequency, and adverse events were recorded at 3, 6, and 12 months after PER introduction. Subanalyses by early or late use of PER and by concomitant ASM were also conducted.
Five hundred and three patients were included (age 36.5 ± 19.9 years). Eighty-one percent had focal epilepsy. Overall, the retention rate was very high in the whole group (89% at 12 months) according with efficacy measures. No major differences were observed in the subanalyses, although patients who used PER as early add-on, as compared with late add-on, more often reached early seizure freedom at 3-month follow-up (66% vs 53%, P = .05). Treatment-emergent adverse events occurred in 25%, far less commonly than in PER randomized trials.
This study confirms the good efficacy and safety of PER for focal or generalized epilepsy in real-life conditions. We provide robust data about its effectiveness as only add-on treatment even in patients with a long-standing history of epilepsy and previously treated with many ASMs.
吡仑帕奈（PER）被批准作为青少年及成人癫痫患者的辅助抗癫痫药物（ASM）。临床试验数据显示其疗效和耐受性良好，但关于PER常规临床应用的信息有限，尤其是仅作为添加治疗使用时。
我们对年龄大于12岁的局灶性或全身性癫痫患者进行了一项观察性、回顾性、多中心研究，这些患者是从52家意大利癫痫中心连续招募的。所有患者均按照标准临床实践接受PER作为背景ASM的唯一添加治疗。在引入PER后的3个月、6个月和12个月记录保留率、癫痫发作频率和不良事件。还根据PER的早期或晚期使用以及伴随的ASM进行了亚组分析。
共纳入503例患者（年龄36.5±19.9岁）。81%患有局灶性癫痫。总体而言，根据疗效指标，整个组的保留率非常高（12个月时为89%）。亚组分析未观察到重大差异，尽管与晚期添加相比，早期添加PER的患者在3个月随访时更常实现早期癫痫发作缓解（66%对53%，P = 0.05）。25%的患者出现治疗中出现的不良事件，远比PER随机试验中少见。
本研究证实了PER在现实生活中对局灶性或全身性癫痫的良好疗效和安全性。我们提供了有力数据，证明即使对于有长期癫痫病史且先前接受多种ASM治疗的患者，PER作为唯一添加治疗的有效性。
