METHODS: Observational, retrospective, phase 4 study on subjects receiving cenobamate in three Spanish centers. The primary endpoint was the retention rate at the last follow-up. The main secondary endpoints were the 50%-responder and seizure-free rates at three months and the last follow-up. Other secondary endpoints were Global Clinical Impressions-Improvement (CGI-I) scores and treatment-emergent adverse events (TEAEs).
RESULTS: Fifty-one patients with highly refractory focal epilepsy with 24.7 years of disease evolution, ten previously tried ASM, and a 23.5% of previous epilepsy surgery were included. The retention rate at the last follow-up was 80.4%. The 50% responder rate in focal seizures at three months was 56.5% (median reduction per month 51%, 0-74.6; p < 0.0001) and in focal to bilateral tonic-clonic seizures was 63.6% (median reduction per month 89%, 0-100; p = 0.022). A total of 54.3% of subjects reported a reduction in the intensity of focal seizures, and 66% manifested clinically significant satisfaction. Cenobamate allowed a significant decrease in concomitant ASM, especially sodium channel blockers. TEAEs were reported in 43.1% of individuals, 85% of whom resolved or improved, with no new safety findings.
CONCLUSIONS: In this analysis of patients with highly refractory focal epilepsy treated with cenobamate according to standard clinical practice, there was evidence of a high reduction in both seizure frequency and intensity, with a manageable safety profile.
方法:观察性,回顾性,在三个西班牙中心接受cenobamate的受试者的4期研究。主要终点是最后一次随访时的保留率。主要次要终点是3个月和最后一次随访时50%的应答者和无癫痫发作率。其他次要终点是全球临床印象改善(CGI-I)评分和治疗引起的不良事件(TEAE)。
结果:51例高度难治性局灶性癫痫患者,病程24.7年,十个以前尝试过的ASM,并纳入了23.5%的既往癫痫手术.末次随访保留率为80.4%。三个月局灶性癫痫发作的50%应答率为56.5%(每月减少51%,0-74.6;p<0.0001),双侧强直阵挛性癫痫发作为63.6%(每月中位数减少89%,0-100;p=0.022)。共有54.3%的受试者报告局灶性癫痫发作强度降低,和66%表现出临床上显著的满意度。Cenobamate允许伴随的ASM显着减少,尤其是钠通道阻滞剂。在43.1%的个体中报告了TEAE,85%的人解决或改善,没有新的安全性发现。
结论:在本分析中,根据标准的临床实践,使用西诺巴酯治疗的高度难治性局灶性癫痫患者,有证据表明癫痫发作的频率和强度都有很高的降低,具有可管理的安全性。