Abstract：
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
METHODS: 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.
RESULTS: 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.
摘要：
目的：拉科酰胺是一种广泛使用的第三代抗癫痫药物。然而,缺乏关于用仿制药代替品牌拉科沙胺的安全性的证据.这项研究旨在确定与癫痫患者从品牌名称转换为拉科沙胺（LCM）通用形式相关的临床结果。
方法：这项前瞻性观察性研究涉及在大学癫痫诊所接受LCM治疗的患者。2018年，与通用产品相比，波兰品牌LCM的价格上涨了110倍。预计由于经济限制，大多数患者会选择改用通用制剂，我们选择前瞻性地对其进行随访,以评估从品牌型LCM过渡到通用型LCM的安全性.
结果：共81名患者，18-62岁,诊断为局灶性癫痫并在我们机构接受LCM治疗，决定从品牌(Vimpat)转向通用变体(LacosamideTEVA，LacosamideGlenmark,和拉科酰胺协议）。跟着开关，在治疗前后的癫痫发作频率方面没有观察到显著差异(p=0.55,Wilcoxon符号秩检验).随后，在转换后的初次随访中，有4例患者（4.9％）发生了不良事件，包括嗜睡（2例）和头晕（2例）。值得注意的是,所有不良事件均通过第二次随访解决,无需修改治疗方案.重要的是,结论：在我们的研究中发现拉科沙胺的通用替代通常是安全的。尽管如此，为了证实我们的发现,需要更大的前瞻性研究。
方法：这项前瞻性观察性研究涉及在大学癫痫诊所接受LCM治疗的患者。2018年，与通用产品相比，波兰品牌LCM的价格上涨了110倍。预计由于经济限制，大多数患者会选择改用通用制剂，我们选择前瞻性地对其进行随访,以评估从品牌型LCM过渡到通用型LCM的安全性.
结果：共81名患者，18-62岁,诊断为局灶性癫痫并在我们机构接受LCM治疗，决定从品牌(Vimpat)转向通用变体(LacosamideTEVA，LacosamideGlenmark,和拉科酰胺协议）。跟着开关，在治疗前后的癫痫发作频率方面没有观察到显著差异(p=0.55,Wilcoxon符号秩检验).随后，在转换后的初次随访中，有4例患者（4.9％）发生了不良事件，包括嗜睡（2例）和头晕（2例）。值得注意的是,所有不良事件均通过第二次随访解决,无需修改治疗方案.重要的是,结论：在我们的研究中发现拉科沙胺的通用替代通常是安全的。尽管如此，为了证实我们的发现,需要更大的前瞻性研究。
