Prioritizing Antidiabetic Drugs for Inflammatory Bowel Disease Through Inverse Signal Detection: A FAERS Pharmacovigilance Study
Abstract
Background/Objectives: Inflammatory bowel disease (IBD) represents a growing therapeutic challenge, and the identification of novel treatment strategies remains an unmet clinical need. Drug repurposing offers a pragmatic and cost-effective alternative to de novo drug development. This study aimed to identify candidate drugs for repurposing in IBD through inverse signal detection within a large spontaneous pharmacovigilance database. Methods: In this observational, retrospective pharmacovigilance study, data from the FDA Adverse Event Reporting System (FAERS) were analyzed using OpenVigil 2.1. Drugs inversely associated with IBD were identified based on a ROR p-value Results: Of 3585 initial drug-event combinations evaluated, 73 candidates met predefined criteria for statistical significance, pharmacokinetic feasibility, and clinical relevance. Within this broader pool, ten antidiabetic agents which demonstrated meaningful inverse signal strength were selected for in-depth analysis: dulaglutide (ROR 0.181, 95% CI 0.136-0.242), insulin lispro (ROR 0.206, 95% CI 0.161-0.263), insulin glargine (ROR 0.246, 95% CI 0.205-0.295), insulin (ROR 0.340, 95% CI 0.295-0.390), insulin aspart (ROR 0.349, 95% CI 0.267-0.455), empagliflozin (ROR 0.400, 95% CI 0.311-0.514), liraglutide (ROR 0.419, 95% CI 0.319-0.552), metformin (ROR 0.446, 95% CI 0.407-0.489), sitagliptin (ROR 0.460, 95% CI 0.376-0.563), and semaglutide (ROR 0.622, 95% CI 0.507-0.764). The subsequent literature review…
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