Department of Neurology, Pusan National University School of Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Busan, Republic of Korea.
Department of Neurology, Pusan National University School of Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Busan, Republic of Korea.
Seizure. 2018 Aug;60:127-131. doi: 10.1016/j.seizure.2018.06.020. Epub 2018 Jun 25.
Levetiracetam is one of the most widely used antiepileptic drugs, but the evidence related to the safety of substitution from brand name to generic levetiracetam is scarce. The present study evaluated the risk of increased frequency of seizures after replacement of a brand-name levetiracetam with a generic product.
We enrolled patients with epilepsy who were treated with branded levetiracetam for at least 6 months of sustained use. Patients were advised to switch to the generic levetiracetam. We analyzed data from 6 months before, to 6 months after, generic substitution. Increased seizure frequency was defined as a≥ 50% increase in seizure frequency after conversion date compared with seizure frequency before the conversion date. We analyzed changes in seizure frequency and performed subgroup analysis according to changes in seizure frequency.
We analyzed 148 epilepsy patients. Among the 148 patients, 109 (73.6%) were seizure-free before substitution and 105 patients remained seizure-free after switching. After generic substitution, an increased seizure frequency was noted in seven patients (4.7%), and a decreased seizure frequency was noted in 10 (6.8%). Patients with decreased seizure frequency were significantly younger (p = 0.035) than those with an unchanged seizure frequency.
This study suggests that the risk of increased seizure frequency after generic substitution was minimal. The generic substitution of levetiracetam was generally safe, although larger prospective studies are warranted to corroborate our findings.
左乙拉西坦是最广泛使用的抗癫痫药物之一，但关于从品牌名药物转换为仿制药的安全性证据有限。本研究评估了用仿制药替代品牌名左乙拉西坦后癫痫发作频率增加的风险。
我们招募了至少连续使用品牌名左乙拉西坦治疗 6 个月的癫痫患者。建议患者转换为仿制药左乙拉西坦。我们分析了转换日期前 6 个月至转换日期后 6 个月的数据。癫痫发作频率增加定义为转换日期后癫痫发作频率较转换日期前增加≥50%。我们分析了癫痫发作频率的变化，并根据癫痫发作频率的变化进行了亚组分析。
我们分析了 148 例癫痫患者。在这 148 例患者中，有 109 例（73.6%）在转换前无癫痫发作，有 105 例在转换后仍无癫痫发作。在仿制药替代后，有 7 例（4.7%）癫痫发作频率增加，有 10 例（6.8%）癫痫发作频率降低。癫痫发作频率降低的患者明显比癫痫发作频率不变的患者年轻（p=0.035）。
本研究表明，仿制药替代后癫痫发作频率增加的风险极小。尽管需要更大的前瞻性研究来证实我们的发现，但一般来说，左乙拉西坦的仿制药替代是安全的。
