Strengthening Inferential Studies in the U.S. FDA Sentinel Initiative: Results from a Methodological Demonstration Project

This poster describes a Sentinel study that evaluated the risk of acute pancreatitis after initiating sodium-glucose co-transporter 2 sodium-glucose co-transporter 2 (SGLT2i) vs. dipeptidyl peptidase-4 inhibitor (DPP-4i) in type 2 diabetes patients, using FDA Sentinel’s Real-World Evidence Data Enterprise (RWE-DE), which links electronic health records (EHR) and claims data for over 25 million individuals. The study highlights the value of EHR-linked data in addressing emerging safety concerns. It was presented at the 2025 ISPE Annual Meeting.