Cardiac adverse events associated with lacosamide: a disproportionality analysis of the FAERS database

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 Sy...

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Vydáno v:	Scientific reports Ročník 14; číslo 1; s. 16202 - 12
Hlavní autoři:	Yang, Chengcheng, Zhao, Wanqi, Chen, Huihui, Yao, Yinhui, Zhang, Jingmin
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	London Nature Publishing Group UK 13.07.2024 Nature Publishing Group Nature Portfolio
Témata:	631/154/1438 631/154/570 Adolescent Adult Adverse Drug Reaction Reporting Systems - statistics & numerical data Adverse events Aged Anticonvulsants - adverse effects Antiepileptic agents Cardiac adverse events Cardiac arrest Cardiac arrhythmia Cardiotoxicity - epidemiology Cardiotoxicity - etiology Clinical trials Databases, Factual Diabetic neuropathy Disproportionality analyses Drugs Epilepsy FAERS database FDA approval Female Heart Hospitals Humanities and Social Sciences Humans Lacosamide Lacosamide - adverse effects Male Middle Aged multidisciplinary Pharmacy Reporting odds ratio Science Science (multidisciplinary) Statistical analysis United States - epidemiology United States Food and Drug Administration Young Adult United States Disproportionality analyses Reporting odds ratio FAERS database Cardiac adverse events Lacosamide
ISSN:	2045-2322, 2045-2322
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Shrnutí:	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.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23
ISSN:	2045-2322 2045-2322
DOI:	10.1038/s41598-024-67209-0