Musculoskeletal adverse events associated with bempedoic acid: a real-world pharmacovigilance study

Musculoskeletal adverse reactions (MAEs) caused by statins are the main reason that limits their clinical application. Bempedoic acid provides an alternative treatment option for patients who cannot tolerate statins as a novel oral lipid-lowering drug. The objective of this study was to perform data mining using the FDA Adverse Event Reporting System (FAERS) to realistically observe and systematically summarize bempedoic acid-related MAEs in the real world. The FAERS database from the first quarter of 2020 to the fourth quarter of 2024 was retrospectively queried to characterize reporting of MAEs with bempedoic acid. The association between bempedoic acid and MAEs was evaluated using the reporting odds ratio (ROR) and the Bayesian Confidence Propagation Neural Network, followed by univariate logistic regression to explore factors influencing MAEs. MAEs accounted for 19.64% of the total number of bempedoic acid reports. The median onset time of MAEs with bempedoic acid was 12.5 days. Disproportion analysis showed that myalgia had the strongest AE signal (ROR 30.1[95% CI 24.93-36.35]). Subgroup analyses of age, sex, and weight showed no significant differences in the risk of bempedoic acid-related MAEs. Notably, age >65 years and male patients were significant risk factors for reporting serious MAEs ( p <0.001 and p =0.015, respectively). This real-world pharmacovigilance study suggested a significant association between the MAEs and bempedoic acid. Elderly male patients were more likely to develop serious MAEs. Enhanced monitoring is recommended when administering bempedoic acid to high-risk populations.