The Cardiac and Renal Safety of Semaglutide in Patients with Type 2 Diabetes: A Real-World Study Based on FAERS.

IF 2.9 4区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Cardiorenal Medicine Pub Date : 2025-01-01 Epub Date: 2025-05-11 DOI:10.1159/000546238

Jingyu Wang, Tong Xie, Yuemiao Zhang, Hong Zhang

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引用次数: 0

Abstract

Background: Recently, a large clinical trial found that treatment with semaglutide significantly reduced the risk of renal damage and cardiovascular death in patients with type 2 diabetes (T2D). To validate these findings and ensure the suitability of the drug, it is necessary to address the renal and cardiac safety of semaglutide in patients with T2D through real-world safety evidence.

Methods: We examined post-marketing data on the use of semaglutide in patients with T2D using disproportionality analysis based on the FDA Adverse Event Reporting System database. We focused on the detection of positive signals for acute and chronic renal injury and cardiac adverse events associated with semaglutide therapy.

Results: A total of 2,380 patients were enrolled in semaglutide therapy in T2D patients with no renal or cardiac positive signals in four algorithmic thresholds, including disproportionality analysis.

Conclusions: In the current study, we observed no significant cardiac or renal safety signals in patients with T2D treated with semaglutide. Our results provide further support for its use as initial and combination therapy in relevant populations.

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西马鲁肽对2型糖尿病患者心脏和肾脏的安全性：基于FAERS的真实世界研究。

背景：最近，一项大型临床试验发现，用西马鲁肽治疗可显著降低2型糖尿病（T2D）患者肾损害和心血管死亡的风险。为了验证这些发现并确保药物的适用性，有必要通过真实世界的安全性证据来解决西马鲁肽对T2D患者肾脏和心脏的安全性问题。方法：我们使用基于FDA不良事件报告系统数据库的歧化分析，检查了西马鲁肽药物在T2D患者中使用的上市后数据。我们专注于检测与西马鲁肽治疗相关的急性和慢性肾损伤和心脏不良事件的阳性信号。结果：包括非对称分析在内的四种算法阈值中，共有2380例患者接受了西马鲁肽治疗，这些患者没有肾脏或心脏阳性信号。结论：在目前的研究中，我们观察到在接受西马鲁肽治疗的T2D患者中没有明显的心脏或肾脏安全信号。我们的结果进一步支持在相关人群中作为初始和联合治疗。此外，这些发现强调了西马鲁肽在慢性肾脏疾病患者中的治疗潜力。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cardiorenal Medicine CARDIAC & CARDIOVASCULAR SYSTEMS-UROLOGY & NEPHROLOGY

CiteScore

5.40

自引率

2.60%

发文量

审稿时长

>12 weeks

期刊介绍： The journal ''Cardiorenal Medicine'' explores the mechanisms by which obesity and other metabolic abnormalities promote the pathogenesis and progression of heart and kidney disease (cardiorenal metabolic syndrome). It provides an interdisciplinary platform for the advancement of research and clinical practice, focussing on translational issues.