Holtkamp M, McMurray R, Bagul M, Sousa R, Kockelmann E
Epilepsy-Center Berlin-Brandenburg, Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Eisai Europe Ltd, Hatfield, Hertfordshire, UK.
Acta Neurol Scand. 2016 Jul;134(1):76-82. doi: 10.1111/ane.12574. Epub 2016 Feb 24.
To assess retention, tolerability, and safety, efficacy and effects on quality of life (QoL) of eslicarbazepine acetate (ESL) add-on treatment over 6 months in a real-world adult population with partial-onset seizures.
This non-interventional, multicenter, prospective study was performed in eight European countries. Adult patients (n = 247) for whom the physician had decided to initiate ESL as add-on to an existing antiepileptic drug (AED) monotherapy were invited to participate. The study comprised three visits: baseline, and after 3 and 6 months. Data on ESL retention, efficacy, tolerability, safety, and QoL were collected.
After 6 months, the retention rate of ESL was 82.2%, and 81.8% of patients reported a reduction of seizure frequency of at least 50%; 39.2% of patients reported seizure freedom at this time. The mean QOLIE-10 score improved from 2.9 (SD ± 0.8) at baseline to 2.1 (SD ± 0.8) after 6 months. 109 adverse events (AEs) were reported in 57 patients (26.0%); the majority were rated as related to ESL by the investigator and led to a discontinuation of ESL in 25 patients (11.4%). Eight patients (3.7%) suffered at least one serious AE. The most frequently reported AEs were dizziness, headache, convulsion, and fatigue.
This study shows that ESL was well tolerated and efficacious as add-on therapy to one baseline AED. The use of ESL in patients less refractory than those included in previous clinical trials led to higher responder and seizure freedom rates. No new safety issues were observed.
评估醋酸艾司利卡西平（ESL）作为添加治疗药物，在6个月内对部分性发作的成年癫痫患者的保留率、耐受性、安全性、疗效及生活质量（QoL）的影响。
这项非干预性、多中心、前瞻性研究在8个欧洲国家开展。邀请了247名成年患者参与，这些患者经医生决定开始将ESL作为现有抗癫痫药物（AED）单药治疗的添加药物。该研究包括三次访视：基线访视、3个月后访视和6个月后访视。收集了关于ESL保留率、疗效、耐受性、安全性和生活质量的数据。
6个月后，ESL的保留率为82.2%，81.8%的患者报告癫痫发作频率降低了至少50%；此时39.2%的患者报告无癫痫发作。QOLIE-10平均评分从基线时的2.9（标准差±0.8）提高到6个月后的2.1（标准差±0.8）。57名患者（26.0%）报告了109起不良事件（AE）；调查人员将大多数不良事件评定为与ESL有关，25名患者（11.4%）因此停用ESL。8名患者（3.7%）至少发生了1起严重不良事件。最常报告的不良事件为头晕、头痛、惊厥和疲劳。
本研究表明，ESL作为一种添加治疗药物耐受性良好且有效。与之前临床试验纳入的患者相比，难治性较低的患者使用ESL导致更高的缓解率和无癫痫发作率。未观察到新的安全问题。
