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

Wang, Jingyu
Xie, Tong
Zhang, Yuemiao
Zhang, Hong

^aRenal Division, Peking University First Hospital, Beijing, China
^bPeking University Institute of Nephrology, Beijing, China
^cKey Laboratory of Renal Disease, Ministry of Health of China, Beijing, China
^dKey Laboratory of Chronic Kidney Disease Prevention and Treatment (Peking University), Ministry of Education, Beijing, China
^eResearch Units of Diagnosis and Treatment of Immune-mediated Kidney Diseases, Chinese Academy of Medical Sciences, Beijing, China

^*Yuemiao Zhang, [email protected], Hong Zhang, [email protected]

Received December 24, 2024; Accepted April 30, 2025; previously published online May 11, 2025

Cardiorenal Medicine 15(1):p 413-422, January-February-March-April-May-June-July-August-September-October-November-December 2025. | DOI: 10.1159/000546238

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.