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

Abstract

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

Research design andmethods: The FAERS database wassearched to extract the adverse reactions of bempedoic acid from the third quarterof 2020 to the fourth quarter of 2023. After data standardization, theReporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), BayesianConfidence Propagation Neural Network (BCPNN), and Multi-item Gamma PoissonShrinker (MGPS) methods were used to comprehensively evaluate the adversereaction signals.

Results: A total of 1091adverse reaction reports were identified, and 70 adverse reaction terms wereobtained, 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." PreferredTerms (PTs)withhigh signal intensity had low density lipoprotein abnormality, elevated blooduric acid, biliary colic, etc. New adverse reaction signals such as esophagealspasm, angina, apathy were reported.

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