Real-world assessment of sparsentan’s drug safety framework

Sparsentan has been approved for reducing proteinuria in adult patients with primary IgA nephropathy (IgAN) at risk of rapid disease progression, yet comprehensive studies evaluating its drug safety framework are lacking. Adverse event (AE) reports following the market release of sparsentan were col...

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Bibliographic Details
Published in:Renal failure Vol. 47; no. 1; p. 2461668
Main Authors: Fu, Wenjing, Wang, Jingyu, Xue, Yuzhou, Pan, Dikang
Format: Journal Article
Language:English
Published: England Taylor & Francis Group 01.12.2025
Subjects:
Adolescent
Adult
Adverse Drug Reaction Reporting Systems
adverse events
Angiotensin II Type 1 Receptor Blockers - adverse effects
Clinical Trials, Phase III as Topic
Endothelin A Receptor Antagonists - adverse effects
FAERS
Female
Glomerulonephritis, IGA - drug therapy
Humans
IgA nephropathy
Male
pharmacovigilance
Retrospective Studies
sparsentan
Young Adult
FAERS
IgA nephropathy
adverse events
sparsentan
pharmacovigilance
ISSN:0886-022X, 1525-6049, 1525-6049
Online Access:Get full text
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Summary:Sparsentan has been approved for reducing proteinuria in adult patients with primary IgA nephropathy (IgAN) at risk of rapid disease progression, yet comprehensive studies evaluating its drug safety framework are lacking. Adverse event (AE) reports following the market release of sparsentan were collected from the U.S. Food and Drug Administration AE Reporting System. Disproportionate analysis was used to identify previously unrecognized positive novel signals at both the system organ class and preferred term levels. Additionally, analysis on clinical priorities and subgroup analysis were conducted. A total of 504 patients with IgAN were included. Two novel system organ classes and 14 novel preferred terms were identified. Hypotension and dizziness were established as moderate clinical priority events. Males had a higher relative risk of nausea, peripheral edema, feeling abnormal, decreased blood pressure, and hypotension, while females were at greater risk for fatigue, pain, increased blood creatinine, dizziness, and somnolence. Among those aged 18-45, the relative risk of experiencing fatigue, pain, and dizziness was higher, individuals aged 45 and older had a higher relative risk of peripheral edema, decreased blood pressure, and hypotension. Based on the available AE reporting data, sparsentan exhibits a favorable safety profile, with no high-priority clinical events identified. Our findings offer valuable insights to optimize the use of sparsentan and understand its potential side effects.
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ISSN:0886-022X
1525-6049
1525-6049
DOI:10.1080/0886022X.2025.2461668