Department for Neurosurgery, Epilepsy Center, Medical Center, University of Freiburg, Breisacher Str. 64, Freiburg 79106, Germany.
Department for Neurosurgery, Epilepsy Center, Medical Center, University of Freiburg, Breisacher Str. 64, Freiburg 79106, Germany.
Seizure. 2022 Nov;102:129-133. doi: 10.1016/j.seizure.2022.10.004. Epub 2022 Oct 4.
Cenobamate (CNB) is a new antiseizure medication (ASM) for the treatment of focal epilepsy in adults. While efficacy of CNB was confirmed in controlled clinical trials, its effects on cognition are unclear. Cognitive adverse effects of ASM affect quality of life and retention rate. Therefore, we investigated whether the adjunctive treatment with CNB is associated with changes in cognitive performance.
Efficacy and tolerability of CNB were investigated in an observational study. Fifty patients with pharmacoresistant focal epilepsy aged 18 to 71 years (Mdn = 37.5 years) were tested before (T0) and after reaching the first target dose of CNB, usually after three months (T1). Cognitive performance was assessed using the EpiTrack©, a change-sensitive screening tool for attention and executive functions.
The median CNB dose at T1 was 125 mg/day (range: 50 - 250 mg/day). Most patients received 2-3 concomitant ASMs. Individual test scores remained stable in 72%, significantly improved in 16%, and significantly deteriorated in 12% of the patients from T0 to T1. The total group showed a significant improvement in EpiTrack scores (p < .01). Changes in EpiTrack performance from T0 to T1 occurred independently of CNB dose, changes in the total drug load or reduction in seizure frequency.
Most of the patients showed stable or improved cognitive performance. Thus, there is preliminary evidence that adjunctive CNB is not associated with an increased risk of cognitive side effects for the majority of patients. These findings need to be confirmed in controlled trials encompassing higher doses.
苯巴比妥（CNB）是一种新的抗癫痫药物（ASM），用于治疗成人局灶性癫痫。虽然 CNB 在对照临床试验中已被证实有效，但它对认知的影响尚不清楚。ASM 的认知不良反应会影响生活质量和保留率。因此，我们研究了 CNB 的辅助治疗是否与认知表现的变化有关。
我们在一项观察性研究中调查了 CNB 的疗效和耐受性。50 名年龄在 18 至 71 岁（中位数为 37.5 岁）的耐药性局灶性癫痫患者在达到 CNB 的第一个目标剂量之前（T0）和之后（T1）接受了测试，通常是在三个月后。使用 EpiTrack©评估认知表现，这是一种用于注意力和执行功能的敏感筛选工具。
T1 时的 CNB 剂量中位数为 125mg/天（范围：50-250mg/天）。大多数患者接受了 2-3 种同时使用的 ASM。72%的患者个体测试分数保持稳定，16%的患者显著改善，12%的患者显著恶化。总组的 EpiTrack 评分显著提高（p<0.01）。从 T0 到 T1，EpiTrack 表现的变化与 CNB 剂量、总药物负荷或癫痫发作频率的减少无关。
大多数患者的认知表现稳定或改善。因此，初步证据表明，对于大多数患者，辅助使用 CNB 不会增加认知副作用的风险。这些发现需要在包含更高剂量的对照试验中得到证实。
