Department of Neurology, Epilepsy-Center Berlin-Brandenburg, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Beaumont Hospital, Royal College of Surgeons in Ireland, Dublin, Ireland.
Acta Neurol Scand. 2019 Jan;139(1):49-63. doi: 10.1111/ane.13023. Epub 2018 Oct 2.
To assess the effectiveness and safety/tolerability of eslicarbazepine acetate (ESL) monotherapy in clinical practice in Europe.
Euro-Esli was a pooled analysis of 14 European clinical practice studies. Responder rate (≥50% seizure frequency reduction) and seizure freedom rate (seizure freedom at least since prior visit) were assessed after 3, 6 and 12 months of ESL treatment and at last visit. Adverse events (AEs) and AEs leading to ESL discontinuation were assessed throughout follow-up. A subanalysis was conducted to assess outcomes for patients treated initially with ESL monotherapy and for patients treated at the last visit with ESL monotherapy.
ESL was used as monotherapy in 88/2045 (4.3%) patients initially and in 229/1340 (17.1%) patients at the last visit. At 12 months, responder and seizure freedom rates were 94.1% and 88.2%, respectively, in patients treated initially with ESL monotherapy, and 93.2% and 77.4%, respectively, in patients treated at the last visit with ESL monotherapy. Corresponding values for patients treated initially with ESL adjunctive therapy were 74.8% and 39.0%, respectively; and for patients treated at the last visit with ESL adjunctive therapy, corresponding values were 70.4% and 25.9%, respectively. Safety and tolerability were generally comparable in patients treated with ESL as monotherapy or adjunctive therapy. The most commonly reported AEs (≥5% of patients in any group) were dizziness, somnolence, instability/ataxia, and fatigue.
These clinical practice data support the use of ESL as monotherapy, as well as adjunctive therapy, for focal-onset seizures, complementing evidence from clinical trials.
评估醋酸艾司利卡西平（ESL）单药治疗在欧洲临床实践中的疗效和安全性/耐受性。
Euro-Esli 是对 14 项欧洲临床实践研究的汇总分析。在 ESL 治疗 3、6 和 12 个月后以及最后一次就诊时评估应答率（≥50%发作频率减少）和无发作率（至少自上次就诊以来无发作）。在整个随访期间评估不良事件（AE）和导致 ESL 停药的 AE。进行了一项亚分析，以评估最初接受 ESL 单药治疗的患者和最后一次就诊时接受 ESL 单药治疗的患者的结局。
ESL 最初作为单药治疗用于 88/2045（4.3%）例患者，最后一次就诊时用于 229/1340（17.1%）例患者。在 12 个月时，最初接受 ESL 单药治疗的患者应答率和无发作率分别为 94.1%和 88.2%，最后一次就诊时接受 ESL 单药治疗的患者分别为 93.2%和 77.4%。最初接受 ESL 辅助治疗的患者相应值分别为 74.8%和 39.0%；最后一次就诊时接受 ESL 辅助治疗的患者相应值分别为 70.4%和 25.9%。接受 ESL 单药或辅助治疗的患者的安全性和耐受性通常相当。报告发生率≥5%（任何组中）的最常见 AE 为头晕、嗜睡、不稳定/共济失调和疲劳。
这些临床实践数据支持 ESL 作为单药治疗，以及辅助治疗局灶性发作，补充了临床试验的证据。
