Comprehensive analysis of sparsentan-related adverse events: latest insights from VigiAccess and FAERS.

Abstract

Background: Sparsentan represents a major advancement in the treatment of proteinuric kidney diseases, offering a promising option to improve patient outcomes and slow disease progression. Evaluation of its safety profile is essential to support its long-term integration into clinical practice.

Methods: This study employed a retrospective descriptive analysis combined with four advanced statistical methods to evaluate adverse events related to sparsentan. The data, sourced from the WHO's VigiAccess database, was queried in November 2024 to retrieve adverse event reports associated with sparsentan. The Food and Drug Administration Adverse Event Reporting System (FAERS) database has also been utilized to conduct an in-depth analysis of adverse events associated with sparsentan.

Results: A total of 1476 adverse events associated with sparsentan were reported in VigiAccess until the end of November 2024. The analysis revealed that the ten most frequently reported adverse events included dizziness, fatigue, product use in unapproved indication, hypotension, nausea, peripheral swelling, headache, blood pressure decrease, pruritus, wrong technique in product usage process.

Conclusions: While the majority of adverse events were mild and self-limiting, there were instances of severe events that could have led to hospitalization or even fatalities. It is crucial to actively prioritize primary safety research on sparsentan, with a particular focus on cohort event monitoring, to better understand and establish causal relationships between the treatment and reported adverse events.