Levetiracetam versus Carbamazepine in Patients with Late Poststroke Seizures: A Multicenter Prospective Randomized Open-Label Study (EpIC Project)
Levetiracetam versus Carbamazepine in Patients with Late Poststroke Seizures: A Multicenter Prospective Randomized Open-Label Study (EpIC Project)
复制标题
DOI：
10.1159/000342669
复制
发表时间：
2012-01-01
影响因子：
2.9
通讯作者：
Toni, D.
中科院分区：
文献类型：
--
作者：
Consoli, D.;Bosco, D.;Toni, D.
背景：中风是成年人癫痫发作的主要原因，占65岁以上人群癫痫发作的50%。建议使用抗癫痫药物预防卒中后癫痫发作复发。研究方法：在一项多中心、随机、开放标签研究中，128例卒中后癫痫患者被随机分配至左乙拉西坦（LEV）或缓释卡马西平（CBZ）治疗组。在滴定研究阶段（2周）后，确定试验药物的最佳个体剂量，并继续治疗52周。主要终点定义为无癫痫患者的比例;次要终点为：评估首次癫痫发作的时间复发、EEG描记、认知功能和副作用。结果如下：在128例患者中，22例提前终止试验;因此，共有106例患者（52例接受LEV治疗，54例接受CBZ治疗）被纳入分析。研究结果如下：LEV和CBZ之间无并发症的患者数量无显著差异（p = 0.08）; LEV组患者的首次复发时间往往较长;两个治疗组的治疗效果与EEG结果之间无相关性; LEV引起的复发率显著降低，（p = 0.02）副作用比CBZ;注意力缺陷，额叶执行功能和功能量表（日常生活活动和日常生活活动指数的工具）在CBZ组中显著更差。结论：本试验表明，LEV可能是一个有效的替代CBZ中风后癫痫发作，特别是在疗效和安全性。此外，我们的研究结果表明，LEV在认知功能方面优于CBZ。该试验还表明，LEV单药治疗是中风后癫痫发作的老年患者安全有效的治疗选择。版权所有（C）2012 S. Karger AG，巴塞尔
Background: Strokes are the leading cause of epileptic seizures in adults and account for 50% of seizures in those over the age of 65 years. The use of antiepileptic drugs to prevent recurrent poststroke seizures is recommended. Methods: One hundred and twenty-eight patients with poststroke seizures were randomly allocated to treatment with either levetiracetam (LEV) or sustained-release carbamazepine (CBZ) in a multicenter randomized open-label study. After a titration study phase (2 weeks), the optimal individual dose of trial medication was determined and treatment was continued for another 52 weeks. The primary endpoint was defined as the proportion of seizure-free patients; the secondary endpoints were: evaluation of time recurrence to the first seizure, EEG tracings, cognitive functions and side effects. Results: Of 128 patients, 22 discontinued the trial prematurely; thus a total of 106 patients (52 treated with LEV and 54 treated with CBZ) were included in the analysis. The results of the study were as follows: no significant difference in number of seizure-free patients between LEV and CBZ (p = 0.08); time to the first recurrence tended to be longer among patients on LEV; there was no correlation between the therapeutic effect and the EEG findings in either treatment group; LEV caused significantly fewer (p = 0.02) side effects than CBZ; attention deficit, frontal executive functions and functional scales (Activities of Daily Living and Instrumental Activities of Daily Living indices) were significantly worse in the CBZ group. Conclusions: This trial suggests that LEV may be a valid alternative to CBZ in poststroke seizures, particularly in terms of efficacy and safety. In addition, our results show that LEV has significant advantages over CBZ on cognitive functions. This trial also indicates that LEV in monotherapy is a safe and effective therapeutic option in elderly patients who have suffered epileptic seizures following a stroke. Copyright (C) 2012 S. Karger AG, Basel