Assessment of adverse events of the novel cardiovascular drug vericiguat: a real-world pharmacovigilance study based on FAERS.

ABSTRACT

BACKGROUND: This study aims to analyze the adverse event reports (AERs) to vericiguat using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) and provide evidence for the clinical use. METHODS: AERs due to vericiguat from 2021Q1 to 2024Q1 identified as the primary suspect were screened, with duplicate reports subsequently eliminated. Various quantitative signal detection methods, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and multi-item gamma poisson shrinker, were then employed for data mining and analysis. Signal strength is represented by the 95% confidence interval, information component (IC), and empirical Bayesian geometric mean (EBGM). RESULTS: A total of 617 vericiguat-related AERs were identified. Strong signals were observed in 21 system organ classes. Furthermore, the most frequently reported preferred terms (PT) was hypotension (n = 86, ROR 25.92, PRR 24.11, IC 4.59, EBGM 24.07), followed by dizziness (n = 52, ROR 6.44, PRR 6.20, IC 2.63, EBGM 6.20), malaise (n = 25, ROR 3.59, PRR 3.54, IC 1.82, EBGM 3.54), blood pressure decreased (n = 23, ROR 20.00, PRR 19.64, IC 4.29, EBGM 19.61), and anemia (n = 21, ROR 6.67, PRR 6.57, IC 2.72, EBGM 6.57). CONCLUSIONS: This study extended the adverse reactions documented in the FDA instruction and provided supplementary evidence regarding the clinical safety of vericiguat.