University of California, San Francisco, CA, United States.
University of Wisconsin, Madison, WI, United States.
Epilepsy Res. 2021 Mar;171:106561. doi: 10.1016/j.eplepsyres.2021.106561. Epub 2021 Jan 12.
We report outcomes from an open-label, non-randomized, 24-week study of eslicarbazepine acetate (ESL) in adults at earlier and later stages of their treatment history for focal seizures, conducted in a real-world clinical setting.
ESL was taken as the first adjunctive therapy to levetiracetam (LEV) or lamotrigine (LTG) monotherapy (Arm 1), or as a later adjunctive therapy in treatment-resistant patients (Arm 2). The primary objective was to evaluate the effectiveness of ESL (by retention rates). Secondary objectives were to evaluate efficacy (seizure frequency), safety, tolerability, behavioral changes, mood, and health-related quality of life (HRQoL) associated with ESL treatment.
The modified intent-to-treat population included 96 patients (Arm 1: n = 41; Arm 2: n = 55) and the safety population included 102 patients (Arm 1: n = 44; Arm 2: n = 58). Overall, 81.8 % of patients in Arm 1 and 63.8 % of patients in Arm 2 completed the 24-week maintenance period. Median reductions in standardized seizure frequency (SSF) were markedly higher in Arm 1 (72.8 %) than Arm 2 (22.8 %), as were responder rates (≥50 % reduction in SSF; Arm 1: 62.5 %; Arm 2: 38.5 %) and rates of seizure freedom (Arm 1: 25.0 %; Arm 2: 9.6 %). Efficacy outcomes were generally more favorable in patients taking ESL in combination with LEV versus other anti-seizure medications (ASMs). Treatment-emergent adverse events (TEAEs; 81 % vs 73 %) and TEAEs leading to discontinuation (16 % vs 2 %) were reported more frequently in Arm 2 than Arm 1, respectively. Serious adverse events were reported infrequently (Arm 1: 0; Arm 2: 7 %). The most common TEAEs were dizziness, nausea, headache, somnolence, fatigue, nasopharyngitis, vomiting, and anxiety. There were no notable changes in depressive symptoms, mood status, or aggression throughout the study. Health and HRQoL scores were generally high at baseline and did not change throughout the study. However, on average, both clinicians and patients perceived improvement in illness over the course of the study.
ESL was effective and well tolerated both as the first adjunctive therapy to either of the most prescribed first-line ASMs, LEV or LTG, and as a later adjunctive therapy in treatment-resistant patients.
我们报告了一项在现实临床环境中进行的、针对局灶性癫痫发作患者在治疗早期和晚期接受艾司利卡西平（ESL）治疗的开放性、非随机、24 周研究的结果，该研究为单盲、非随机、24 周的研究。
ESL 作为左乙拉西坦（LEV）或拉莫三嗪（LTG）单药治疗的一线辅助治疗（臂 1），或作为耐药患者的二线辅助治疗（臂 2）。主要目的是评估 ESL 的有效性（通过保留率）。次要目标是评估疗效（癫痫发作频率）、安全性、耐受性、与 ESL 治疗相关的行为变化、情绪和健康相关生活质量（HRQoL）。
修改后的意向治疗人群包括 96 名患者（臂 1：n = 41；臂 2：n = 55）和安全性人群包括 102 名患者（臂 1：n = 44；臂 2：n = 58）。总体而言，臂 1 中有 81.8%的患者和臂 2 中有 63.8%的患者完成了 24 周的维持期。与臂 2（22.8%）相比，臂 1 中标准化癫痫发作频率（SSF）的中位数降低幅度明显更高（72.8%），反应率（SSF 降低≥50%；臂 1：62.5%；臂 2：38.5%）和无癫痫发作率（臂 1：25.0%；臂 2：9.6%）也更高。与其他抗癫痫药物（ASMs）相比，ESL 联合 LEV 治疗的患者的疗效结果通常更有利。与臂 1 相比，臂 2 中报告的治疗中出现的不良事件（TEAEs；81% vs 73%）和导致停药的 TEAEs（16% vs 2%）更为频繁。分别报告了少数严重不良事件（臂 1：0；臂 2：7%）。最常见的 TEAEs 是头晕、恶心、头痛、嗜睡、疲劳、鼻咽炎、呕吐和焦虑。整个研究过程中抑郁症状、情绪状态或攻击性均无明显变化。健康和 HRQoL 评分在基线时通常较高，整个研究过程中均无变化。然而，平均而言，临床医生和患者都认为在研究过程中疾病有所改善。
ESL 作为最常开处方的一线抗癫痫药物（LEV 或 LTG）之一的一线辅助治疗，以及作为耐药患者的二线辅助治疗，均具有疗效且耐受性良好。
