Diabetes
Do incretin drugs flag biliary harm in FAERS?
Open access · cc by · source: Europe PMC
Among 2,215 biliary FAERS reports, DPP-4 inhibitors had ROR 3.09 (sitagliptin 3.46); overall GLP-1 RAs were called non-significant (ROR 1.60) but semaglutide (4.06) and liraglutide (3.88) signaled.
Study at a glance
- Design
- Other — FAERS/OpenVigil 2.1 disproportionality (ROR, PRR, BCPNN, EBGM) of GLP-1 RAs and DPP-4 inhibitors vs biliary SMQs, Q1 2013–Q1 2024
- N
- N=2215 · 2,215 biliary adverse-event reports (1,709 GLP-1 RA; 506 DPP-4 inhibitor) with the drug as primary suspect
- Population
- Spontaneous FAERS reports for six GLP-1 RAs and four DPP-4 inhibitors, 2013 Q1–2024 Q1
- Outcome
- Reporting odds ratios and serious-outcome fractions for biliary SMQ subgroups including gallstones and biliary malignancy
Structured fields used in claim comparison tables when every cited study has a complete layer.
Key findings
2,215 biliary AEs (1,709 GLP-1 RA; 506 DPP-4). DPP-4 class ROR 3.09; sitagliptin 3.46. GLP-1 class ROR 1.60 was labeled not significant, but semaglutide and liraglutide signaled. Serious outcomes: 76.88% of DPP-4 vs 51.55% of GLP-1 reports.
Methodology
Pulled OpenVigil/FAERS primary-suspect reports for GLP-1 RAs and DPP-4 inhibitors (Q1 2013–Q1 2024), mapped biliary SMQs, and ran ROR, PRR, BCPNN, and EBGM disproportionality plus serious-outcome counts.
Limitations
FAERS cannot prove incidence or causality; stimulated reporting, confounding by indication, and missing denominators bias RORs, and “not significant” for GLP-1 overall used a stricter signal rule than CI excluding 1.
How this study connects
Role on claims
Each row is a claim on a concept or method page where this paper supports, challenges, or qualifies the statement. Roles are hand-checked — not a model guess.
FAERS biliary signals were clearer for DPP-4 inhibitors than for GLP-1 RAs as a class, with agent exceptions.
Among 2,215 biliary FAERS reports, DPP-4 inhibitors had ROR 3.09 (sitagliptin 3.46). Overall GLP-1 RAs were called non-significant (ROR 1.60), but semaglutide (4.06) and liraglutide (3.88) signaled; serious outcomes were 76.88% of DPP-4 vs 51.55% of GLP-1 reports.
Evidence for the claim as stated.
A T2D EHR comparison of tirzepatide versus GLP-1 RAs is not a pancreatitis incidence study, not a biliary FAERS ROR, and is not a T1D add-on trial. Class talk still needs the indication, comparator, and design named.
Evidence for the claim as stated.
Open questions
Tensions this paper is part of
From concept pages' “where studies disagree.” Disagreement means the same question; scope means different assays, populations, or outcomes.
A T2D EHR comparison of tirzepatide versus GLP-1 RAs is not a pancreatitis incidence study, not a biliary FAERS ROR, and is not a T1D add-on trial. Class talk still needs the indication, comparator, and design named.
History
When this study was placed
Dated entries from the concept change log — when this paper was added or removed as support, challenge, or qualifier on a claim.
Placed as supporting evidence on GLP-1 receptor agonists
Among 2,215 biliary FAERS reports, DPP-4 inhibitors had ROR 3.09 (sitagliptin 3.46). Overall GLP-1 RAs were called non-significant (ROR 1.60), but semaglutide (4.06) and liraglutide (3.88) signaled; serious outcomes were 76.88% of DPP-4 vs 51.55% of GLP-1 reports.
Placed as supporting evidence on GLP-1 receptor agonists
A T2D EHR comparison of tirzepatide versus GLP-1 RAs is not a pancreatitis incidence study, not a biliary FAERS ROR, and is not a T1D add-on trial. Class talk still needs the indication, comparator, and design named.
Related papers in this topic
Same topic cluster — not a recommendation engine.