该分析评估了布立西坦(BRV)在老年(≥65岁)和年轻(≥16至<65岁)成人癫痫患者中的有效性和耐受性。这是来自EXPERIENCE/EPD332的亚组分析,这是来自多个独立患者的单个患者记录的汇总分析,在澳大利亚开始BRV的癫痫患者的非干预性研究,欧洲,和美国。纳入患者的随访数据≥6个月。结果包括反应者(癫痫发作频率比基线降低≥50%),癫痫发作自由(在时间点之前的3个月内没有癫痫发作),12个月时无持续癫痫发作(从基线开始无癫痫发作);整个研究随访期间BRV停药;3、6和12个月时因治疗引起的不良事件(TEAE).BRV停药后数据缺失的患者被认为是无反应者/非无癫痫发作。分析人群包括完整分析集(FAS;接受≥1次BRV剂量且基线时记录有癫痫发作类型和年龄的患者)和改良FAS(基线时记录有≥1次癫痫发作的FAS患者)。FAS用于除癫痫发作减少外的所有结果。FAS包括年龄≥65岁的147例(8.9%)和年龄≥16至<65岁的1497例(91.1%)。与年轻亚组相比,年龄≥65岁的患者中位癫痫持续时间较长(33.0年[n=144]vs17.0年[n=1460]),中位癫痫发作频率较低(2.0次癫痫发作/28天[n=129]vs4.0次癫痫发作/28天[n=1256]),较不常见的既往抗癫痫药物治疗>1(106/141[75.2%]vs1265/1479[85.5%])。12个月时,年龄≥65岁的患者与较年轻的亚组相比,癫痫发作减少≥50%的患者百分比更高(46.5%[n=71]vs36.0%[n=751]),癫痫发作自由(26.0%[n=100]对13.9%[n=1011]),持续发作自由(22.0%[n=100]vs10.7%[n=1011])。在整个研究随访期间,43/147(29.3%)年龄≥65岁的患者和508/1492(34.0%)年龄≥16至<65岁的患者停止BRV。两个亚组3个月时的TEAE发生率相似(≥65岁vs≥16至<65岁:38/138[27.5%]vs356/1404[25.4%]),6个月(19/119[16.0%]vs176/1257[14.0%]),和12个月(8/104[7.7%]对107/1128[9.5%])。这项现实世界的分析表明,BRV对年龄≥65岁和≥16至<65岁的患者有效。在较老的亚组中具有较高的数值有效性。BRV在两个亚组中均有良好的耐受性。
This analysis assessed the effectiveness and tolerability of brivaracetam (BRV) in older (≥65 years of age) and younger (≥16 to <65 years of age) adults with epilepsy. This was a subgroup analysis from EXPERIENCE/EPD332, a pooled analysis of individual patient records from multiple independent, non-interventional studies of patients with epilepsy starting BRV in Australia, Europe, and the United States. Included patients had ≥6 months of follow-up data. Outcomes included responders (≥50 % reduction from baseline in seizure frequency), seizure freedom (no seizures within 3 months before the time point), and continuous seizure freedom (no seizures from baseline) at 12 months; BRV discontinuation during the whole study follow-up; and treatment-emergent adverse events (TEAEs) at 3, 6, and 12 months. Patients with missing data after BRV discontinuation were deemed non-responders/not seizure-free. Analysis populations included the Full Analysis Set (FAS; patients who received ≥1 BRV dose and had seizure type and age documented at baseline) and the modified FAS (FAS patients who had ≥1 seizure recorded during baseline). The FAS was used for all outcomes except seizure reduction. The FAS included 147 (8.9 %) patients aged ≥65 years and 1497 (91.1 %) aged ≥16 to <65 years. Compared with the younger subgroup, patients aged ≥65 years had a longer median epilepsy duration (33.0 years [n = 144] vs 17.0 years [n = 1460]) and lower median seizure frequency at index (2.0 seizures/28 days [n = 129] vs 4.0 seizures/28 days [n = 1256]), and less commonly had >1 prior antiseizure medication (106/141 [75.2 %] vs 1265/1479 [85.5 %]). At 12 months, a numerically higher percentage of patients aged ≥65 years versus the younger subgroup achieved ≥50 % seizure reduction (46.5 % [n = 71] vs 36.0 % [n = 751]), seizure freedom (26.0 % [n = 100] vs 13.9 % [n = 1011]), and continuous seizure freedom (22.0 % [n = 100] vs 10.7 % [n = 1011]). During the whole study follow-up, 43/147 (29.3 %) patients aged ≥65 years and 508/1492 (34.0 %) aged ≥16 to <65 years discontinued BRV. The incidence of TEAEs since the prior visit was similar in both subgroups at 3 months (≥65 years vs ≥16 to <65 years: 38/138 [27.5 %] vs 356/1404 [25.4 %]), 6 months (19/119 [16.0 %] vs 176/1257 [14.0 %]), and 12 months (8/104 [7.7 %] vs 107/1128 [9.5 %]). This real-world analysis suggests BRV was effective in patients aged ≥65 years and ≥16 to <65 years, with numerically higher effectiveness in the older subgroup. BRV was well tolerated in both subgroups.