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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Bibliographic Details
Published in:Scientific reports Vol. 14; no. 1; pp. 16202 - 12
Main Authors: Yang, Chengcheng, Zhao, Wanqi, Chen, Huihui, Yao, Yinhui, Zhang, Jingmin
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 13.07.2024
Nature Publishing Group
Nature Portfolio
Subjects:
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
Online Access:Get full text
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Summary: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.
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ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-024-67209-0