对斯帕森坦药物安全框架的实际评估。

IF 3 3区 医学 Q1 UROLOGY & NEPHROLOGY
Renal Failure Pub Date : 2025-12-01 Epub Date: 2025-02-19 DOI:10.1080/0886022X.2025.2461668
Wenjing Fu, Jingyu Wang, Yuzhou Xue, Dikang Pan
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引用次数: 0

摘要

背景:Sparsentan已被批准用于降低具有疾病快速进展风险的成人原发性IgA肾病(IgAN)患者的蛋白尿,但缺乏评估其药物安全性框架的全面研究。方法:从美国食品药品监督管理局不良事件报告系统中收集斯帕森坦上市后的不良事件报告。不成比例的分析被用来在系统器官类别和首选术语水平上识别以前未被识别的积极新信号。并进行临床重点分析和亚组分析。结果:共纳入504例IgAN患者。确定了两个新的系统器官类别和14个新的首选术语。低血压和头晕被确定为中度临床优先事件。男性出现恶心、外周水肿、感觉异常、血压下降和低血压的相对风险较高,而女性出现疲劳、疼痛、血肌酐升高、头晕和嗜睡的相对风险较高。在18-45岁的人群中,出现疲劳、疼痛和头晕的相对风险更高,45岁及以上的人群出现外周水肿、血压下降和低血压的相对风险更高。结论:根据现有的AE报告数据,sparsentan显示出良好的安全性,没有发现高优先级的临床事件。我们的研究结果为优化斯巴达坦的使用和了解其潜在的副作用提供了有价值的见解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-world assessment of sparsentan's drug safety framework.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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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来源期刊
Renal Failure
Renal Failure 医学-泌尿学与肾脏学
CiteScore
3.90
自引率
13.30%
发文量
374
审稿时长
1 months
期刊介绍: Renal Failure primarily concentrates on acute renal injury and its consequence, but also addresses advances in the fields of chronic renal failure, hypertension, and renal transplantation. Bringing together both clinical and experimental aspects of renal failure, this publication presents timely, practical information on pathology and pathophysiology of acute renal failure; nephrotoxicity of drugs and other substances; prevention, treatment, and therapy of renal failure; renal failure in association with transplantation, hypertension, and diabetes mellitus.
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