Post-marketing pharmacovigilance study of inclisiran: mining and analyzing adverse event data from the FDA Adverse Event Reporting System database.

Abstract

Background: Inclisiran, the newest lipid-lowering drug, has not shown significant safety problems in major clinical studies. However, its recent market introduction and limited clinical use have produced few reports of adverse reactions, leaving a comprehensive understanding of its long-term safety yet to be established.

Aim: The aim of the study was to conduct a signal detection analysis of adverse events (AEs) associated with inclisiran using FDA Adverse Event Reporting System (FAERS) datasets.

Method: Data on AEs associated with inclisiran were collected from the FAERS database from 2021 to 2023. Signal detection was conducted using the reporting odds ratio (ROR) and the information component (IC). The analysis was standardized using the Medical Dictionary for Regulatory Activities (MedDRA) and focused on System Organ Classes (SOCs) and Preferred Terms.

Results: Of 17,307,196 AE reports, 2976 were relevant to inclisiran. The male-to-female ratio of these events was 0.74:1, predominantly in patients aged 45 to 74 years. A total of 102 AE signals associated with inclisiran were identified in 15 SOCs. Among these, 86 involved muscle injuries, liver injuries, diabetes, neurocognitive dysfunction, and other events not listed on the drug label.

Conclusion: The findings confirm all AEs documented on the drug label and in current clinical trials while also revealing new AEs such as muscle pain, elevated liver enzymes, increased blood glucose levels, and neurocognitive dysfunction. This study contributes to real-world research data, providing valuable references for rational drug use.