Epilepsy Center Frankfurt Rhine-Main, Neurocenter, University Hospital Frankfurt and Center for Personalized Translational Epilepsy Research (CePTER), Goethe-University, Frankfurt am Main, Germany.
Bethel Epilepsy Centre, Mara Hospital, Bielefeld, Germany.
Acta Neurol Scand. 2020 Jun;141(6):473-482. doi: 10.1111/ane.13230. Epub 2020 Mar 13.
To assess tolerability and efficacy of lacosamide in adults with cerebrovascular epilepsy etiology (CVEE).
Exploratory post hoc analyses of a double-blind, initial monotherapy trial of lacosamide vs carbamazepine-controlled release (carbamazepine-CR) (SP0993; NCT01243177); a double-blind conversion to lacosamide monotherapy trial (SP0902; NCT00520741); and an observational study of adjunctive lacosamide added to one antiepileptic drug (SP0973 VITOBA; NCT01098162). Patients with CVEE were identified based on epilepsy etiology recorded at baseline.
In the initial monotherapy trial, 61 patients had CVEE (lacosamide: 27; carbamazepine-CR: 34). 20 (74.1%) patients on lacosamide (27 [79.4%] on carbamazepine-CR) reported treatment-emergent adverse events (TEAEs), most commonly (≥10%) headache, dizziness, and fatigue (carbamazepine-CR: headache, dizziness). A numerically higher proportion of patients on lacosamide than carbamazepine-CR completed 6 months (22 [81.5%]; 20 [58.8%]) and 12 months (18 [66.7%]; 17 [50.0%]) treatment without seizure at last evaluated dose. In the conversion to monotherapy trial, 26/30 (86.7%) patients with CVEE reported TEAEs, most commonly (≥4 patients) dizziness, convulsion, fatigue, headache, somnolence, and cognitive disorder. During lacosamide monotherapy, 17 (56.7%) patients were 50% responders and six (20.0%) were seizure-free. In the observational study, 36/83 (43.4%) patients with CVEE reported TEAEs, most commonly (≥5%) fatigue and dizziness. Effectiveness was assessed for 75 patients. During the last 3 months, 60 (80%) were 50% responders and 42 (56.0%) were seizure-free.
These exploratory post hoc analyses suggested lacosamide was generally well tolerated and effective in patients with CVEE, with data from the initial monotherapy trial suggesting numerically better efficacy than carbamazepine-CR.
评估拉科酰胺在脑血管病癫痫病因（CVEE）成人患者中的耐受性和疗效。
对拉科酰胺与卡马西平控释剂（carbamazepine-CR）（SP0993；NCT01243177）初始单药试验、拉科酰胺单药转换双盲试验（SP0902；NCT00520741）和添加一种抗癫痫药物的辅助性拉科酰胺观察性研究（SP0973 VITOBA；NCT01098162）的探索性事后分析；患者根据基线时记录的癫痫病因确定为 CVEE。
在初始单药试验中，61 例患者患有 CVEE（拉科酰胺：27；carbamazepine-CR：34）。20 例（74.1%）拉科酰胺患者（27 例[79.4%]carbamazepine-CR）报告治疗中出现的不良事件（TEAEs），最常见的是（≥10%）头痛、头晕和疲劳（carbamazepine-CR：头痛、头晕）。与 carbamazepine-CR 相比，接受拉科酰胺治疗的患者在最后一次评估剂量时完成 6 个月（22 [81.5%]；20 [58.8%]）和 12 个月（18 [66.7%]；17 [50.0%]）治疗而无癫痫发作的比例更高。在转换为单药治疗试验中，26/30（86.7%）CVEE 患者报告了 TEAEs，最常见的是（≥4 例）头晕、抽搐、疲劳、头痛、嗜睡和认知障碍。在拉科酰胺单药治疗期间，17 例（56.7%）患者为 50%应答者，6 例（20.0%）患者无癫痫发作。在观察性研究中，36/83（43.4%）CVEE 患者报告了 TEAEs，最常见的是（≥5%）疲劳和头晕。对 75 例患者进行了有效性评估。在最后 3 个月期间，60 例（80%）为 50%应答者，42 例（56.0%）无癫痫发作。
这些探索性事后分析表明，拉科酰胺通常耐受性良好，对 CVEE 患者有效，初始单药试验数据表明疗效优于 carbamazepine-CR。
