Novel insights into post-marketing AEs associated with bempedoic acid: a comprehensive analysis utilizing the FAERS database.

Abstract

Background: Bempedoic acid is a new drug for lowering low-density lipoprotein cholesterol. This study used the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to retrospectively mine adverse events of oral bempedoic acid in the real world.

Research design and methods: The FAERS database was searched to extract the adverse reactions of bempedoic acid from the third quarter of 2020 to the fourth quarter of 2023. After data standardization, the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) methods were used to comprehensively evaluate the adverse reaction signals.

Results: A total of 1091 adverse reaction reports were identified, and 70 adverse reaction terms were obtained, involving 22 system categories. According to the ROR signal ranking, the most affected System Organ Classes (SOCs) were "musculoskeletal and connective tissue disorders,""hepatobiliary disorders," and "investigation." Preferred Terms (PTs) with high signal intensity had low density lipoprotein abnormality, elevated blood uric acid, biliary colic, etc. New adverse reaction signals such as esophageal spasm, angina, apathy were reported.

Conclusions: This study provide support for clinical monitoring and risk identification of bempedoic acid.