Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, Italy.
Acta Neurol Scand. 2018 Jan;137(1):29-32. doi: 10.1111/ane.12803. Epub 2017 Jul 25.
The aim of the study was to assess the clinical response to eslicarbazepine acetate (ESL) as add-on therapy in adult patients with partial-onset epilepsy by means of the time-to-baseline seizure count method.
We retrospectively identified consecutive patients with partial-onset seizures, with or without secondary generalization, prescribed to ESL add-on therapy. The primary endpoint was the time-to-baseline monthly seizure count. Subgroup analysis was performed according to carbamazepine (CBZ)/oxcarbazepine (OXC) status (prior vs never use). Secondary outcomes were the rate of treatment-related adverse events (AEs) and the AEs affecting ≥5% of patients.
One-hundred and eighteen patients were included. The median time-to-baseline monthly seizure count was 46 (35-101) days in the overall study cohort. The number of concomitant anti-epileptic drugs (AEDs) was associated with the time-to-endpoint (adjusted hazard ratio [ HR]=2.22, 95% CI 1.18-4.14, P=.013 for two AEDs vs one; HR=3.65, 95% CI 1.66-8.06, P=.001 for three or more AEDs vs one). Groupwise, the median times-to-baseline seizure count were 47 (35-97) and 43 (34-103) in patients with prior and never exposure to CBZ/OXC, respectively (P for log-rank test=.807). Adverse events occurred in 53.4% (63 of 118) of patients; the most frequently reported were dizziness (13.6%), somnolence (11.9%), nausea (6.8%), and fatigue (5.1%).
Add-on ESL improved seizure control and was overall well-tolerated in adult patients with partial-onset epilepsy.
本研究旨在通过基线至发作计数时间方法评估醋酸艾司利卡西平（ESL）作为添加疗法在部分发作性癫痫成人患者中的临床疗效。
我们回顾性地确定了服用 ESL 添加疗法的伴有或不伴有继发全面性发作的部分发作性癫痫患者。主要终点为基线每月发作计数时间。根据卡马西平（CBZ）/奥卡西平（OXC）用药史（既往使用 vs 从未使用）进行亚组分析。次要结局为治疗相关不良事件（AE）发生率和影响≥5%患者的 AE。
共纳入 118 例患者。总体研究队列的基线每月发作计数时间中位数为 46（35-101）天。同时使用的抗癫痫药物（AED）数量与终点时间相关（调整后的风险比[HR]=2.22，95%可信区间 1.18-4.14，P=.013，与使用 1 种 AED 相比；HR=3.65，95%可信区间 1.66-8.06，P=.001，与使用 3 种或更多 AED 相比）。组间分析，既往使用 CBZ/OXC 与从未使用 CBZ/OXC 的患者的基线发作计数时间中位数分别为 47（35-97）和 43（34-103）（对数秩检验 P 值=.807）。53.4%（63/118）的患者发生了不良事件；最常报告的是头晕（13.6%）、嗜睡（11.9%）、恶心（6.8%）和疲劳（5.1%）。
添加 ESL 可改善发作控制，且总体上对伴有部分发作性癫痫的成年患者具有良好的耐受性。
