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

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.

Keywords: Adverse event; Cardiac disorders; Kidney injury; Pharmacovigilance; Semaglutide; Type 2 diabetes.