Chang Gung Memorial Hospital and New Taipei Municipal TuCheng Hospital, New Taipei City, Taiwan; Department of Neurology, Xiamen ChangGung Hospital, Xiamen, Fujian, China.
Department of Neurology, Konkuk University Hospital, Seoul, Republic of Korea.
J Neurol Sci. 2024 Nov 15;466:123173. doi: 10.1016/j.jns.2024.123173. Epub 2024 Aug 14.
This post-hoc analysis of the PERMIT Extension study compared the effectiveness and safety/tolerability of perampanel (PER) between Asian and non-Asian participants. Retention rates, adverse events (AEs), seizure frequency, responder rate (≥50% seizure frequency reduction), and seizure freedom rate (no seizures since at least the prior visit) were assessed. Retention was assessed after 3, 6 and 12 months. Effectiveness assessments were evaluated at 3, 6 and 12 months and the last visit by seizure type (total, focal and generalised). PERMIT Extension included 730 Asian and 1662 non-Asian individuals. Significant differences in demographic/baseline characteristics were reported for the Asian versus non-Asian subgroups including higher median age at epilepsy onset, longer median duration of epilepsy, higher mean number of previous and concomitant ASMs and lower mean monthly seizure frequency (total, focal and generalised). Retention rates were similar between the two subgroups at 3 and 12 months, but significantly lower in the Asian versus non-Asian subgroup at 6 months (65.6% vs. 71.8%; p = 0.004). At last visit, seizure freedom rate was significantly higher in the Asian versus non-Asian for total (35.9% vs. 25.4%; p = 0.001) and focal seizures (32.4% vs. 18.9%; p = 0.001) as was responder rate for both total (63.9% vs. 52.3%; p = 0.001) and focal seizures (62.2% vs. 44.7%; p < 0.001). Seizure freedom and responder rates for generalised seizures were similar between the two subgroups at the last visit. Rates of AEs were similar between the two subgroups (Asian, 47.6%; non-Asian, 45.4%). PER was effective and generally well-tolerated in Asian and non-Asian individuals.
本项 PERMIT 扩展研究的事后分析比较了亚洲和非亚洲参与者中培米贝鲁的有效性和安全性/耐受性。评估了保留率、不良事件（AE）、癫痫发作频率、应答率（≥50%癫痫发作频率降低）和无发作率（自至少前一次就诊以来无发作）。在 3、6 和 12 个月后评估保留率。在 3、6 和 12 个月和最后一次就诊时根据癫痫发作类型（全面性、局灶性和全面性）评估疗效。PERMIT 扩展研究包括 730 名亚洲人和 1662 名非亚洲人。亚洲与非亚洲亚组在人口统计学/基线特征方面存在显著差异，包括癫痫发作起始年龄中位数较高、癫痫发作持续时间中位数较长、既往和合并使用抗癫痫药物（ASM）的平均数量较高、每月癫痫发作频率（全面性、局灶性和全面性）中位数较低。在 3 和 12 个月时，两个亚组的保留率相似，但在 6 个月时亚洲亚组明显低于非亚洲亚组（65.6%比 71.8%；p=0.004）。在最后一次就诊时，亚洲亚组的无发作率在全面性和局灶性癫痫发作方面均显著高于非亚洲亚组（35.9%比 25.4%；p=0.001），应答率在全面性和局灶性癫痫发作方面也均显著高于非亚洲亚组（63.9%比 52.3%；p=0.001）。在最后一次就诊时，全面性和局灶性癫痫发作的无发作率和应答率在两个亚组之间相似。两组间不良事件（AE）发生率相似（亚洲组 47.6%；非亚洲组 45.4%）。培米贝鲁在亚洲和非亚洲人群中是有效的，且通常具有良好的耐受性。
