Cardiac adverse events associated with lacosamide: a disproportionality analysis of the FAERS database
Chengcheng Yang1, Wanqi Zhao2, Huihui Chen3
1Department of Pharmacy, The First People's Hospital of Shangqiu, Shangqiu, 476000, China. ycc424@163.com.
Insights
Lacosamide, a third-generation antiepileptic drug, shows cardiac adverse events (AEs) in real-world data. Analysis of 812 cardiac AEs found 17 significant signals, with most cases appearing early and risk decreasing over time.
Area of Science:
- Pharmacovigilance
- Cardiology
- Neurology
Background:
- Lacosamide is a third-generation antiepileptic drug (AED).
- Real-world data on lacosamide's cardiac adverse events (AEs) are limited.
- Comprehensive cardiac safety evaluation is needed.
Purpose of the Study:
- To evaluate the cardiac safety profile of lacosamide.
- To identify and quantify lacosamide-associated cardiac AEs using real-world data.
- To enhance healthcare professional awareness of potential cardiac risks.
Main Methods:
- Utilized the US Food and Drug Administration Adverse Event Reporting System (FAERS) database (2013 Q1–2022 Q4).
- Employed disproportionality analysis calculating the Reporting Odds Ratio (ROR) to detect safety signals.
- Applied statistical analysis for serious vs. nonserious cases and a rating scale for signal prioritization.
Main Results:
- Identified 812 cardiac AEs linked to lacosamide.
- Detected 92 potential safety signals, with 17 achieving statistical significance (ROR 95% CI lower limit > 1).
- Observed an early-onset pattern for cardiac AEs, with median time-to-onset of 10 days for moderate and 54 days for weak priority signals, indicating a decreasing risk over time.
Conclusions:
- Lacosamide exhibits a cardiac safety profile characterized by early-onset adverse events.
- The risk of cardiac AEs associated with lacosamide appears to decrease over time.
- Findings underscore the importance of monitoring for cardiac AEs in patients treated with lacosamide.
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.
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