Department of Medical Sciences, Institute of Neurology, University Magna Graecia, Catanzaro, Italy.
Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy.
Eur J Neurol. 2018 Apr;25(4):666-671. doi: 10.1111/ene.13568. Epub 2018 Feb 1.
The purpose of this study was to determine whether switching from branded levetiracetam (Keppra ) to a levetiracetam generic equivalent product (Matever ) in an epilepsy cohort could provide adequate results in terms of seizure control and tolerability.
To be eligible for the study, patients had to have been taking Keppra as monotherapy or polytherapy for at least 6 months. Between March 2013 and April 2017, patients were invited to switch to Matever as part of their follow-up. We evaluated the number of seizures per month, drug-related adverse events and electroencephalography before the switch (T0, baseline) and 6 months after switching (T1). Furthermore, we reported the long-term follow-up of patients who continued to use Matever after the end of the study, considering the most recent visit for each patient (T2).
A total of 55 patients refused the switch. Among the remaining 125 patients, 59 (47%) were treated using Keppra as monotherapy and 66 (53%) were on Keppra as polytherapy. All 125 patients were subjected to switching from Keppra to Matever . Comparing patients before (T0) and after (T1) switching, we found no statistically significant differences in terms of seizure frequency and occurrence of adverse effects. There were no significant differences (number of seizures/month and drug-related adverse events) between patients treated with Matever as monotherapy and patients who refused the switch and continued to use Keppra as monotherapy for a long-term follow-up of 48 months. Electroencephalography findings were also unchanged.
In our sample, brand-to-generic levetiracetam switching was effective and safe in both monotherapy and polytherapy regardless of the epilepsy syndrome.
本研究旨在确定在癫痫队列中，从品牌左乙拉西坦（开浦兰）转换为左乙拉西坦仿制药（马维特）是否能在控制癫痫发作和耐受性方面提供同样的效果。
为符合研究条件，患者必须已接受开浦兰单药或多药治疗至少 6 个月。在 2013 年 3 月至 2017 年 4 月期间，邀请患者作为随访的一部分转换为马维特。我们评估了每月发作次数、药物相关不良事件和转换前（T0，基线）和转换后 6 个月（T1）的脑电图。此外，我们报告了研究结束后继续使用马维特的患者的长期随访情况，考虑了每位患者的最近一次就诊（T2）。
共有 55 名患者拒绝转换。在其余的 125 名患者中，59 名（47%）患者接受开浦兰单药治疗，66 名（53%）患者接受开浦兰多药治疗。所有 125 名患者均接受了从开浦兰转换为马维特的治疗。比较转换前（T0）和转换后（T1）的患者，我们发现癫痫发作频率和不良反应发生情况无统计学差异。在接受马维特单药治疗的患者和拒绝转换并继续使用开浦兰单药进行长达 48 个月的长期随访的患者之间，马维特单药治疗的患者和拒绝转换并继续使用开浦兰单药进行长期随访的患者之间，药物相关不良事件发生率和药物相关不良事件发生率无差异（每月发作次数和药物相关不良事件）。脑电图检查结果也没有变化。
在我们的样本中，无论癫痫综合征如何，品牌仿制药转换为左乙拉西坦在单药和多药治疗中均有效且安全。
