Northeast Regional Epilepsy Group, Hackensack Meridian School of Medicine, Hackensack University Medical Center, 30 Prospect Avenue, Hackensack, NJ 07601, United States of America.
University of Tennessee Health Science Center, Le Bonheur Children's Hospital, 49N Dunlap Street, Memphis, TN 38105, United States of America.
Seizure. 2022 May;98:87-94. doi: 10.1016/j.seizure.2022.02.011. Epub 2022 Feb 26.
Report final data from adolescent (12-<18 years) and adult (≥18 years) patients from PROVE (NCT03208660), a multicenter, retrospective, non-interventional, Phase IV study to assess retention, efficacy, safety, and dosing of perampanel in patients with epilepsy during routine clinical care.
Data were retrospectively collected from medical/pharmacy records of patients in the US initiating perampanel after January 1, 2014, according to treating clinicians' recommendation. Retention rate was the primary efficacy endpoint. Secondary endpoints included median percent changes in seizure frequency, seizure-freedom rates, investigator's impression of seizure effect, and treatment-emergent adverse events (TEAEs).
The Safety Analysis Set (SAS) included 294 adolescents and 1157 adults (median maximum perampanel dose, 6.0 mg/day). In patients eligible for inclusion in the retention rate analysis, 24-month retention rates were 53.5% (n=91/170) in adolescents and 47.8% (n=354/741) in adults. In patients with available efficacy data during Months 10-12, median percent seizure frequency reductions were 79.3% (n=20) in adolescents and 70.8% (n=92) in adults. Most patients in the SAS with seizure-effect data experienced an improvement in seizures at the last follow-up time point (adolescents, 51.4% [n=128/249]; adults, 52.3% [n=506/967]). TEAEs occurred in 113 adolescents (38.4%; most common, aggression [6.5%]) and 512 adults (44.3%; most common, dizziness [9.2%]).
Perampanel demonstrated favorable retention rates and sustained efficacy (up to 2 years) in adolescent and adult patients during routine clinical care; no new safety signals were observed.
NCT03208660 (https://clinicaltrials.gov/ct2/show/NCT03208660).
报告来自 PROVE（NCT03208660）的青少年（12-<18 岁）和成年（≥18 岁）患者的最终数据，这是一项多中心、回顾性、非干预性、四期研究，旨在评估在常规临床护理中，依匹仑赛在癫痫患者中的保留率、疗效、安全性和剂量。
根据治疗医生的建议，从 2014 年 1 月 1 日起在美国开始使用依匹仑赛的患者的医疗/药房记录中回顾性收集数据。保留率是主要疗效终点。次要终点包括癫痫发作频率、无癫痫发作率、研究者对癫痫发作效果的印象和治疗中出现的不良事件（TEAEs）的中位数百分比变化。
安全性分析集（SAS）包括 294 名青少年和 1157 名成年人（最大依匹仑赛剂量中位数为 6.0mg/天）。在符合保留率分析纳入条件的患者中，青少年的 24 个月保留率为 53.5%（n=91/170），成年人的为 47.8%（n=354/741）。在 10-12 个月有可用疗效数据的患者中，青少年的癫痫发作频率中位数百分比降低了 79.3%（n=20），成年人的降低了 70.8%（n=92）。在最后一次随访时间点，SAS 中大多数有癫痫发作效果数据的患者癫痫发作得到改善（青少年，51.4%[n=128/249]；成年人，52.3%[n=506/967]）。TEAEs 发生在 113 名青少年（38.4%；最常见的是攻击行为[6.5%]）和 512 名成年人（44.3%；最常见的是头晕[9.2%]）。
在常规临床护理中，依匹仑赛在青少年和成年患者中表现出良好的保留率和持续疗效（长达 2 年）；未观察到新的安全性信号。
NCT03208660（https://clinicaltrials.gov/ct2/show/NCT03208660）。
