Assessing the real-world safety of sparsentan for immunoglobulin A nephropathy: insights from a comprehensive analysis of FAERS database.

objectiveThis study aims to analyze the safety profile of sparsentan in real-world clinical settings using data from the FDA Adverse Event Reporting System (FAERS) database, providing insights for its clinical application.

methodsData from the FAERS database were collected between the first quarter of 2023 and the fourth quarter of 2024. Adverse events (AEs) associated with sparsentan were identified using the proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS). The temporal distribution of AEs was further analyzed using the Weibull distribution to comprehensively assess the safety profile of the drug in clinical practice.

resultsA total of 1776 reports of AEs were retrieved from the FAERS database, with sparsentan identified as the primary suspect (PS) drug. These AEs were reported across 25 system organ classes (SOCs). Forty-four preferred terms (PTs) were retained by the four algorithms, including well-documented adverse reactions listed on the drug label, such as hypotension, hyperkalemia, peripheral edema, and dizziness. In addition, previously unmentioned potential AEs were identified, including nasopharyngitis, ear discomfort, renal pain, and musculoskeletal chest pain. The median time to onset of sparsentan-associated AEs was 18 days (IQR 4-60.5 days), with most events occurring within the first month of treatment.

conclusionThis study provides real-world data on the clinical application of sparsentan and analyzes the AEs associated with its use. It not only confirms several known adverse effects, but also identifies potential new AEs. These findings offer valuable guidance for clinicians prescribing sparsentan, aiding in the reduction of drug-related risks.