Bosak Magdalena, Woźniak Martyna, Kasprzycki Maciej, Słowik Agnieszka
Faculty of Medicine, Department of Neurology, Jagiellonian University Medical College, Krakow, Poland; University Hospital, Krakow, Poland.
School of Medicine, Jagiellonian University Medical College, Poland.
Seizure. 2023 Oct;111:203-205. doi: 10.1016/j.seizure.2023.09.001. Epub 2023 Sep 4.
Lacosamide is a widely used third-generation antiseizure medication. However, there is a lack of evidence regarding the safety of substituting brand-name lacosamide with its generic version. This study aimed to determine the clinical outcomes associated with switching from the brand-name to the generic form of lacosamide (LCM) in patients with epilepsy.
This prospective observational study involved patients undergoing treatment with LCM at the university epilepsy clinic. In 2018, the price of the brand-name LCM in Poland increased up to 110-fold compared to generic products. Anticipating that most patients would opt to switch to the generic formulations due to financial constraints, we chose to follow up them prospectively to assess the safety of transitioning from the brand-name to the generic form of LCM.
A total of 81 patients, aged 18-62 years, diagnosed with focal epilepsy and undergoing LCM treatment at our institution, decided to switch from the brand-name (Vimpat) to generic variations (Lacosamide TEVA, Lacosamide Glenmark, and Lacosamide Accord). Following the switch, no significant difference was observed in terms of seizure frequency before and after (p = 0.55, Wilcoxon signed-rank test). Subsequently, adverse events were recorded in four patients (4.9%) during the initial follow-up visit post-switch, including somnolence (2 patients) and dizziness (2 patients). Notably, all adverse events resolved by the second follow-up visit without necessitating treatment modification. Importantly, no patient switched back to brand-name medication CONCLUSION: The generic substitution of lacosamide was found to be generally safe in our study. Nonetheless, to confirm our findings, larger prospective studies are required.
拉科酰胺是一种广泛使用的第三代抗癫痫药物。然而，关于用其仿制药替代品牌拉科酰胺的安全性，目前缺乏证据。本研究旨在确定癫痫患者从品牌拉科酰胺转换为仿制药形式的拉科酰胺（LCM）相关的临床结果。
这项前瞻性观察性研究纳入了在大学癫痫诊所接受LCM治疗的患者。2018年，波兰品牌LCM的价格相比仿制药上涨了110倍。由于预计大多数患者会因经济限制而选择改用仿制药，我们选择对他们进行前瞻性随访，以评估从品牌LCM转换为仿制药形式的安全性。
共有81名年龄在18至62岁之间、被诊断为局灶性癫痫且在我们机构接受LCM治疗的患者，决定从品牌药（Vimpat）转换为仿制药（拉科酰胺TEVA、拉科酰胺Glenmark和拉科酰胺Accord）。转换后，癫痫发作频率在转换前后没有显著差异（p = 0.55，Wilcoxon符号秩检验）。随后，在转换后的首次随访期间，有4名患者（4.9%）记录到不良事件，包括嗜睡（2例）和头晕（2例）。值得注意的是，所有不良事件在第二次随访时均得到缓解，无需调整治疗。重要的是，没有患者换回品牌药物。结论：在我们的研究中，拉科酰胺的仿制药替代总体上是安全的。尽管如此，为了证实我们的发现，还需要更大规模的前瞻性研究。
