Mining of adverse event signals associated with inclisiran: a post-marketing analysis based on FAERS.

Abstract

Background: This study analyzed adverse events (AEs) associated with inclisiran using the FDA's Adverse Event Reporting System (FAERS) to detect and characterize relevant safety signals.

Methods: We retrospectively extracted AE reports from the FAERS database spanning Q1 2022 to Q2 2024. Four disproportionality analysis algorithms were employed to identify AE signals for inclisiran, with subsequent comparisons made to PCSK9 monoclonal antibodies (alirocumab/evolocumab). Additionally, we examined the characteristics and onset timing of inclisiran-related AE.

Results: A total of 4,122 reports of inclisiran as the 'primary suspected'. Compared with all other drugs, the most significant system organ class (SOC) was 'musculoskeletal and connective tissue disorders' (ROR = 3.64, PRR = 3.19) and the most common SOC was 'general disorders and administration site conditions' (n = 2,769). These two SOCs were more strongly with inclisiran than evolocumab. At the preferred term level, strong signals were detected for cellulitis gangrenous (ROR = 101.29, PRR = 101.27, IC = 6.54, EBGM = 92.91) and bladder discomfort (ROR = 12.61, PRR = 12.61, IC = 3.64, EBGM = 12.48). The median onset time for inclisiran-related AEs was 43 days (interquartile range: 7-99 days).

Conclusions: This study enhanced our understanding of AEs to inclisiran. Future research on its long-term real-world use will offer insights into its safety.