Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Department of Neurology, Hospital Santo António, Centro Hospitalar Porto, Porto, Portugal.
Acta Neurol Scand. 2020 Dec;142(6):563-573. doi: 10.1111/ane.13323. Epub 2020 Aug 12.
To assess the effectiveness and safety/tolerability of eslicarbazepine acetate (ESL) in patients included in the Euro-Esli study who had focal seizures associated with post-stroke epilepsy (PSE).
Euro-Esli was a pooled analysis of 14 European clinical practice studies. Effectiveness assessments (evaluated after 3, 6 and 12 months of ESL treatment and at final follow-up ["last visit"]) included rates of response (≥50% seizure frequency reduction), seizure freedom (no seizures since at least the prior visit) and retention. Safety/tolerability was assessed throughout ESL treatment by evaluating adverse events (AEs) and discontinuation due to AEs. A post hoc analysis was conducted of patients with PSE versus patients without PSE ("non-PSE").
Of 1656 patients included in the analysis, 76 (4.6%) had PSE and 1580 (95.4%) had non-PSE. Compared with non-PSE patients, PSE patients were significantly older, had significantly shorter epilepsy duration, significantly lower total baseline seizure frequency, and were treated with significantly fewer prior and concomitant antiepileptic drugs (P < .001 for all). At the last visit, the responder rate was significantly higher in PSE versus non-PSE patients (72.9% vs 60.6%; P = .040), as was the seizure freedom rate (48.6% vs 31.7%; P = .003). After 12 months, retention was significantly higher in PSE versus non-PSE patients (87.8% vs 77.4%; P = .035). The incidence of AEs was similar for PSE versus non-PSE patients (36.0% vs 35.8%; P = .966).
These findings suggest that ESL may be an effective and well-tolerated treatment option for patients with focal seizures due to PSE.
评估依佐加滨醋酸酯(ESL)在 Euro-Esli 研究中伴有卒中后癫痫(PSE)的局灶性癫痫发作患者中的疗效和安全性/耐受性。
Euro-Esli 是对 14 项欧洲临床实践研究进行的汇总分析。疗效评估(在 ESL 治疗后 3、6 和 12 个月以及最终随访[最后一次就诊]进行评估)包括反应率(≥50%的发作频率降低)、无发作率(至少在前一次就诊后无发作)和保留率。通过评估不良事件(AE)和因 AE 而停药,在整个 ESL 治疗过程中评估安全性/耐受性。对 PSE 患者与非 PSE 患者(“非 PSE”)进行了事后分析。
在纳入分析的 1656 名患者中,76 名(4.6%)患有 PSE,1580 名(95.4%)患有非 PSE。与非 PSE 患者相比,PSE 患者年龄明显较大,癫痫持续时间明显较短,总基线发作频率明显较低,并且接受的既往和合并抗癫痫药物明显较少(所有 P<.001)。在最后一次就诊时,PSE 患者的反应率明显高于非 PSE 患者(72.9%比 60.6%;P=.040),无发作率也明显更高(48.6%比 31.7%;P=.003)。12 个月后,PSE 患者的保留率明显高于非 PSE 患者(87.8%比 77.4%;P=.035)。PSE 患者与非 PSE 患者的 AE 发生率相似(36.0%比 35.8%;P=.966)。
这些发现表明,ESL 可能是伴有 PSE 的局灶性癫痫发作患者的一种有效且耐受良好的治疗选择。