Disproportionality analysis of GLP-1 receptor agonists combined with metformin based on the FAERS database
Abstract
This study analyzed adverse events (AEs) of GLP-1RA and metformin combination therapy using FAERS data (2004-2024). A retrospective disproportionality analysis was conducted using the reporting odds ratio (ROR) on FAERS data (2004-2024), with Bayesian confidence propagation neural network (BCPNN) employed for sensitivity analysis. Adverse reactions were compared between combination therapy and monotherapy (GLP-1 RAs or metformin alone), followed by stratified analyses by gender, age, and body weight. Among 48,214 reports (57.5% female), common AEs included nausea and weight loss. Unexpected signals included kidney injury and pancreatic cancer. Monotherapy showed higher AE rates. Males reported more renal calculi and early-onset AEs (≤ 30 days), while females had delayed AEs (> 360 days). Weight loss was consistent across all demographics. The combination therapy of GLP-1 receptor agonists and metformin demonstrates superior safety over monotherapy, while revealing novel adverse events and demographic-specific risk patterns, thereby offering reliable evidence to inform clinical practice.
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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