Association between GLP-1 RAs and DPP-4 inhibitors with biliary disorders: pharmacovigilance analysis

作者：Long He, Jinwei Li, Xiong Cheng, Li Luo, Yilan Huang · 发表于：Frontiers in Pharmacology · 年份：2025 · DOI：10.3389/fphar.2025.1509561 · 被引用次数：9 · 研究领域：Diabetes Treatment and Management、Pharmacovigilance and Adverse Drug Reactions、Medication Adherence and Compliance

Background and Aims: Incretin-based therapies, including glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and dipeptidyl peptidase-4 (DPP-4) inhibitors, are essential treatments in diabetes management due to their efficacy in glycemic control and the additional benefits of GLP-1 RAs, which include cardiovascular and renal protection. However, concerns about potential associations with biliary disorders necessitate ongoing pharmacovigilance. This study analyzes the link between these drugs and biliary adverse events (AEs) using the FDA Adverse Event Reporting System (FAERS) to enhance clinical safety. Methods: We extracted AE data for GLP-1 RAs and DPP-4 inhibitors from FAERS between Q1 2013 and Q1 2024 using OpenVigil 2.1. Analytical methods such as the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were employed to assess AE risk. Results: A search of biliary disorders by standard MedDRA analytical queries (SMQs) identified 2,215 reports of biliary AEs, with 1,709 related to GLP-1 RAs and 506 to DPP-4 inhibitors. DPP-4 inhibitors showed a significant association with biliary disorders (ROR, 3.09; 95% CI, 2.83-3.37), particularly sitagliptin (ROR, 3.46; 95% CI, 3.13-3.83). Although the overall association for GLP-1 RAs (ROR, 1.60; 95% CI, 1.52-1.68) was not significant, semaglutide (ROR, 4.06; 95% CI, 3.76-4.39) and liraglutide (ROR, 3.88; 95% CI, 3.50-4....