METHODS: We performed a subgroup analysis of PSE patients included in a previous retrospective, longitudinal, multicentre observational study on adults. Treatment discontinuation, seizure frequency and adverse events were collected at 3, 6 and 12 months. Sub-analyses by early (≤1 previous ASM) or late PER add-on were also conducted.
RESULTS: Our analysis included 56 individuals with PSE, characterized by varying initial treatment modalities and timeframes relative to disease onset. We found notable retention rates (92.8%, 83.7%, and 69% at 3, 6, and 12 months), with treatment withdrawal mainly due to poor tolerability. One year after PER introduction, seizure frequency significantly reduced, with a responder rate (≥50% reduction) of 83.9% and a seizure-free rate of 51.6%. Adverse events occurred in 25 (46.3%) patients, mainly dizziness, irritability, and behavioural disorders. No major statistical differences were found between early (30 patients, 53.6%) and late add-on groups, except for a higher 6-month responder rate in the early add-on group.
CONCLUSIONS: Adjunctive PER was effective and well-tolerated in patients with PSE in a real-world setting. Perampanel demonstrated good efficacy and safety as both early and late add-on treatment, making it a compelling option for this unique patient population.
方法:我们对以前的回顾性研究中纳入的PSE患者进行了亚组分析,纵向,成人多中心观察性研究。停止治疗,收集3,6和12个月时的癫痫发作频率和不良事件.还进行了早期(≤1个先前的ASM)或晚期PER附加子分析。
结果:我们的分析包括56名PSE患者,以相对于疾病发作的不同初始治疗方式和时间框架为特征。我们发现显著的保留率(92.8%,83.7%,在3、6和12个月时为69%),治疗退出主要是由于耐受性差。PER引入一年后,癫痫发作频率显著降低,应答率(减少≥50%)为83.9%,无癫痫发作率为51.6%。25例(46.3%)患者发生不良事件,主要是头晕,烦躁,和行为障碍。早期(30例患者,53.6%)和后期附加组,除了早期添加组的6个月应答率更高。
结论:在真实世界环境中,辅助PER在PSE患者中是有效且耐受性良好的。Perampanel在早期和晚期附加治疗中表现出良好的疗效和安全性,使其成为这个独特的患者群体的一个令人信服的选择。