PDF(Pubmed)
Abstract：
Lacosamide was the first approved third-generation antiepileptic drug. However, real-world data regarding its adverse cardiac reactions in large samples still need to be completed. We evaluated the cardiac safety profile of lacosamide using the Food and Drug Administration Adverse Event Reporting System (FAERS). We performed disproportionality analysis computing reporting odds ratio (ROR) as a quantitative metric to assess the signal of lacosamide-related cardiac adverse events (AEs) from 2013 Q1 to 2022 Q4. The signal was considered significant when the lower limit of the 95% confidence interval (CI) of the ROR exceeded 1, and ≥ 5 AEs were reported. Serious and nonserious cases were compared by statistical analysis, and signals were further prioritized using a rating scale. A total of 812 cardiac AEs associated with lacosamide were identified, and 92 signals were detected, of which 17 AEs were significantly associated signals. The median time-to-onset (TTO) for moderate priority signals was 10 days, whereas for weak priority signals, it was 54 days. Notably, all cardiac AEs exhibited an early failing pattern, indicating the risk gradually decreasing. Based on the comprehensive analysis of the FAERS database and prioritization of cardiac AE signals, our research enhances the awareness among healthcare professionals regarding cardiac AEs associated with lacosamide.
摘要：
拉科沙胺是第一个被批准的第三代抗癫痫药物。然而,有关大样本心脏不良反应的真实数据仍需要完成.我们使用食品和药物管理局不良事件报告系统（FAERS）评估了拉科沙胺的心脏安全性。我们进行了不成比例分析，计算报告比值比（ROR）作为定量指标，以评估2013年第一季度至2022年第四季度拉科沙胺相关心脏不良事件（AE）的信号。当ROR的95％置信区间（CI）的下限超过1时，该信号被认为是显着的，并且报告了≥5个AE。通过统计分析比较严重和非严重病例。并使用评级量表进一步确定信号的优先级。共发现812例与拉科沙胺相关的心脏不良事件，检测到92个信号，其中17个AE是显著相关的信号。中度优先信号的中位发病时间（TTO）为10天，而对于弱优先级信号，这是54天。值得注意的是,所有心脏不良事件均表现为早期失败模式，表明风险逐渐降低。基于对FAERS数据库的综合分析和心脏AE信号的优先排序,我们的研究提高了医疗保健专业人员对与拉科沙胺相关的心脏不良事件的认识.
