MON-527 Association of Acute kidney injury with commonly prescribed glucagon-like peptide 1 receptor Agonists: A Pharmacovigilance Analysis

Abstract Disclosure: L. Kattamuri: None. E. Luna Ceron: None. S. Duvvuru: None. K. Sharma: None. L.E. Chozet: None. Background: The advent of innovative pharmacological therapies, particularly glucagon-like peptide-1 receptor agonists (GLP-1RAs), has transformed the management of type 2 diabetes mellitus (T2DM) by optimizing glycemic control and effectively targeting comorbidities, including obesity and cardiovascular diseases. Although recent clinical trials have shown protective renal effects of these medications in patients with chronic kidney disease (CKD), there is also raising contradictory evidence that some GLP-1RAs may be associated with the development of acute kidney injury (AKI) in susceptible patients. Limited epidemiological studies have explored the risk, clinical characteristics, and outcomes of AKI associated with different GLP-1RAs. This study utilized data from the FDA Adverse Event Reporting System (FAERS) to evaluate and compare the real-world association between the most prescribed injectable GLP-1RAs and AKI. Methods: The FAERS database was queried on January 30, 2025, using product-specific terms (‘Dulaglutide,’ ‘Exenatide,’ ‘Liraglutide,’ ‘Semaglutide,’ and ‘Tirzepatide’) to identify 284,492 adverse event reports, including cases of AKI. Descriptive statistics and disproportionality analysis were performed to evaluate the association between different GLP-1 receptor agonists (GLP-1RAs) and AKI. The association was measured using the reporting odds ratio (ROR) with 95% confidence intervals (CI). A significant correlation was defined as an ROR with a lower CI limit exceeding 1. Results: A total of 2,016 cases of AKI associated with GLP-1RAs were identified, with exanetide being the most frequently reported (40.59%). Most AKI cases occurred in males (48.85%) and predominantly in individuals aged 18 to 64 years (45.23%). From the GLP-1RAs studied, Liraglutide showed the strongest association with the development of AKI [ROR 2.05(1.87-2.24)], while also semaglutide [ROR 1.65 (1.50-1.81)] and exenatide [ROR 1.14 (1.05-1.23)] showed also significant associations with the development of AKI. Other GLP-1RAs such as Tirzepatide and Dulaglutide demonstrated no associations with AKI. Conclusions: FAERS data indicated elevated RORs for AKI with liraglutide, semaglutide, and exenatide, suggesting potential safety concerns. However, causality cannot be confirmed due to inherent limitations of FAERS. Further clinical studies are essential to clarify the risk of AKI associated with specific GLP-1RAs in vulnerable patient groups. Presentation: Monday, July 14, 2025