Presentation (CTI)

OBJECTIVES: To evaluate adverse event AE signals associated with Inclisiran and Bempedoic acid, and compare their safety profiles with statins Atorvastatin, Rosuvastatin using FAERS data. Special focus was placed on age and sex differences to assess population‑specific risk.
METHODS: FAERS reports (2020-2024,29 million records) were analyzed. Disproportionality analyses were conducted using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC025), and Empirical Bayes Geometric Mean (EBGM). Subgroup analyses stratified by age (less than65, less then equal to 65, less than equal to 75), sex, and statin co‑use were performed.
RESULTS: Inclisiran (N=600) and Bempedoic acid (N=1700) reports revealed distinct AE patterns. Bempedoic acid was disproportionately associated with musculoskeletal ADRs (myalgia, arthralgia) and serious outcomes (hospitalization, disability, death), particularly in patients ≥65 years. Inclisiran showed signals for cardiovascular ADRs (angina, myocardial infarction) with higher reporting in males. Statins demonstrated expected disproportionality for myopathy and rhabdomyolysis. Female patients reported higher rates of myalgia and arthralgia across all drug classes, while males had elevated cardiovascular ADRs.
CONCLUSIONS: This large‑scale FAERS analysis highlights differential AE profiles between newer lipid‑lowering agents and statins. Bempedoic acid demonstrated higher disproportionality for serious ADRs in older adults, while Inclisiran showed cardiovascular signals in males. These findings underscore the importance of age‑ and sex‑specific pharmacovigilance in lipid management and provide real‑world evidence to inform regulatory and clinical decision‑making.