Bosak Magdalena, Słowik Agnieszka, Turaj Wojciech
Department of Neurology, Jagiellonian University Medical College, Kraków, Poland.
Drug Des Devel Ther. 2017 Aug 3;11:2287-2291. doi: 10.2147/DDDT.S138270. eCollection 2017.
The approach to the use of generic antiepileptic drugs has recently evolved from major concern to general acceptance, but the evidence related specifically to the safety of switching from brand-name to generic levetiracetam (LEV) is scarce. The aim of the study was to assess the risk of increased frequency of seizures or other adverse events after replacement of a brand-name LEV with a generic one.
This retrospective analysis included 159 patients treated with LEV in a tertiary outpatient epilepsy clinic. We included all patients diagnosed with epilepsy who were treated with LEV as at March 1, 2013. Most patients were forced to switch to the generic LEV because of the sudden rise in cost of the branded LEV. We recorded data on age, sex, age at onset of epilepsy, type of epilepsy, and its treatment. We analyzed data from one visit before potential switching and from two visits after the potential switching. The interval between visits was typically 3 months. We registered an increase in the frequency of seizures and in the occurrence of adverse events.
Among 151 subjects who switched to generic LEV after March 1, 2013, increased frequency of seizures was noted in 9 patients (6%) during the first follow-up visit. Patients with increased frequency of seizures did not differ from other patients regarding sex, age, age at the onset of epilepsy, and the median dose of LEV before switching or the median duration of treatment with LEV before switching. Two patients returned to brand-name LEV. Adverse events were noted in six other patients (4%) and included somnolence, irritability, or dizziness.
Switching from brand-name to generic LEV is generally safe.
通用型抗癫痫药物的使用方法近来已从备受关注发展为被普遍接受，但关于从品牌名左乙拉西坦（LEV）转换为通用型左乙拉西坦安全性的具体证据却很匮乏。本研究的目的是评估用通用型左乙拉西坦替代品牌名左乙拉西坦后癫痫发作频率增加或出现其他不良事件的风险。
这项回顾性分析纳入了一家三级门诊癫痫诊所中159例接受左乙拉西坦治疗的患者。我们纳入了所有在2013年3月1日时被诊断为癫痫且接受左乙拉西坦治疗的患者。大多数患者因品牌名左乙拉西坦成本突然上涨而被迫转换为通用型左乙拉西坦。我们记录了年龄、性别、癫痫发病年龄、癫痫类型及其治疗的数据。我们分析了潜在转换前一次就诊以及潜在转换后两次就诊的数据。就诊间隔通常为3个月。我们记录了癫痫发作频率的增加以及不良事件的发生情况。
在2013年3月1日之后转换为通用型左乙拉西坦的151名受试者中，9例患者（6%）在首次随访就诊时癫痫发作频率增加。癫痫发作频率增加的患者在性别、年龄、癫痫发病年龄、转换前左乙拉西坦的中位剂量或转换前左乙拉西坦治疗的中位持续时间方面与其他患者并无差异。两名患者重新使用品牌名左乙拉西坦。另外六名患者（4%）出现了不良事件，包括嗜睡、易怒或头晕。
从品牌名左乙拉西坦转换为通用型左乙拉西坦总体上是安全的。
