Segal Eric, Moretz Katherine, Wheless James, Penovich Patricia, Lancman Marcelo, Patten Anna, Malhotra Manoj
3673Hackensack University Medical Center, 576909Hackensack Meridian School of Medicine, Hackensack, NJ, USA.
576909Northeast Regional Epilepsy Center, Hackensack, NJ, USA.
J Child Neurol. 2022 Mar;37(4):256-267. doi: 10.1177/08830738211047665. Epub 2022 Jan 7.
PROVE is a retrospective, phase IV study assessing retention, dosing, efficacy, and safety of perampanel when administered to patients during routine clinical care. We report an interim analysis of preadolescent (1 to <12 years) and adolescent (12 to <18 years) patients. Data were obtained from medical records of patients with epilepsy initiating perampanel after January 1, 2014; cut-off date for this analysis was October 10, 2018. Overall, 151 preadolescent and 183 adolescent patients were included. Retention rates following 24 months on perampanel were 42.5% (preadolescent subgroup; n = 31/73) and 55.7% (adolescent subgroup; n = 54/97). Treatment-emergent adverse events occurred in 53 (35.1%) preadolescent (most common: aggression, irritability, and somnolence) and 78 (42.6%) adolescent patients (most common: somnolence, aggression, and dizziness). These data indicate that daily oral doses of perampanel are generally well tolerated during routine clinical care, with favorable retention rates for ≤2 years, in patients aged 1 to <18 years.
PROVE是一项回顾性IV期研究，旨在评估在常规临床护理中给予患者吡仑帕奈时的药物留存率、剂量、疗效和安全性。我们报告了对青春期前（1至<12岁）和青少年（12至<18岁）患者的中期分析。数据来自2014年1月1日之后开始使用吡仑帕奈的癫痫患者的医疗记录；该分析的截止日期为2018年10月10日。总体而言，纳入了151名青春期前患者和183名青少年患者。服用吡仑帕奈24个月后的留存率分别为42.5%（青春期前亚组；n = 31/73）和55.7%（青少年亚组；n = 54/97）。53名（35.1%）青春期前患者（最常见的是攻击行为、易怒和嗜睡）和78名（42.6%）青少年患者（最常见的是嗜睡、攻击行为和头晕）出现了治疗中出现的不良事件。这些数据表明，在常规临床护理期间，1至<18岁患者每日口服吡仑帕奈通常耐受性良好，≤2年的留存率良好。
