Objective: The effectiveness and safety of the short-interfering RNA drug inclisiran in lowering patients' lipoprotein cholesterol levels to lower their risk of cardiovascular disease are presently being investigated. Based on the real-world adverse event report record in the FDA Adverse Event Reporting System, this article explores the occurrence and risk of adverse events during inclisiran treatment.
Research design and methods: We retrieved and screened all available data from the Food and Drug Administration website for the period from 2009 to the third quarter of 2023. In addition, we conducted a descriptive analysis of adverse event reports and calculated relevant pharmacovigilance measures, including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and empirical Bayesian geometric mean.
Results: 4054 adverse reaction reports were filtered from 1151 patient reports of inclisiran. The top three incidence rates of adverse reaction signals for System Organ Class in adverse event reports are GENERAL DISORDERS AND ADMINITRATION SITE CONDITIONS (24.9% reported), MUSCOSKELETAL AND CONNECTIVE TISSUE DISORDERS (18.5% reported), and GASTROINTESTINAL DISORDERS (8.7% reported). The top five preferred terms screened for frequency of occurrence with the strongest risk signals for each of the top three system organ categories are INJECTION SITE PAIN，MYALGIA and DIARRHOEA.
Conclusions: Inclisiran has good long-term treatment outcomes and safety and can be used for a long time. However, attention should be paid to adverse events with high-risk signals, especially Injection Site Reactions.
Keywords: FAERS; Inclisiran; PT; SOC; adverse atherosclerotic cardiovascular events; adverse reaction cases; low-density lipoprotein cholesterol; subtilisin/kexin type 9.