Disproportionality Signal Detection of Adverse Events Reported With Inclisiran in the FAERS Database
Year: 2026
Type: article
Study design: Observational Study
Abstract: Presented at STARS 2026. This project presents a comparative disproportionality analysis of adverse events associated with Inclisiran and Bempedoic Acid (BA) using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) from 2022–2024. Reporting Odds Ratios (RORs) were calculated to identify safety signal patterns for each drug. Inclisiran demonstrated stronger reporting signals for metabolic abnormalities—including increased triglycerides, elevated hepatic enzymes, increased LDL‑C, increased blood glucose, and death—while BA showed higher reporting of musculoskeletal and gastrointestinal symptoms such as myalgia, nausea, and arthralgia. These findings provide real‑world pharmacovigilance insights to support clinical decision‑making for non‑statin lipid‑lowering therapies. The project includes a poster summarizing background, methods, results, and implications for public health and clinical practice.
Author: Kumar, Karan
Institution: University of Illinois at Springfield
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W7220781429
