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Diabetes

Do new diabetes drugs show pancreatitis signals in FAERS?

Alenzi KA, Alsuhaibani D, Batarfi B, et al. · Frontiers in pharmacology · 2024

Open access · cc by · source: Europe PMC

FAERS 2019–2021 reports link pancreatitis strongly to DPP-4 inhibitors and GLP-1 RAs, with liraglutide leading within GLP-1s.

How this study connects

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Study at a glance

Design
Qualitative / archival — FAERS spontaneous adverse-event disproportionality analysis (ROR, PRR, EBGM, IC) for pancreatitis with GLP-1 RA, DPP-4, and SGLT2 drugs, 2019–2021
N
N=2313 · 2,313 pancreatitis reports linked to hypoglycemic agents in FAERS
Population
Spontaneous FAERS pancreatitis reports involving GLP-1 RAs, DPP-4 inhibitors, or SGLT2 inhibitors
Outcome
Disproportionality signals (ROR/PRR/EBGM/IC) for pancreatitis by drug class and agent

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Inspect source passages

Do new diabetes drugs show pancreatitis signals in FAERS?

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What data source and years did this pharmacovigilance study use?

FDA Adverse Event Reporting System (FAERS) database from 2019 to 2021

Which drug classes were compared for pancreatitis reporting?

compare the risk of developing pancreatitis between those using GLP-1 RAs and those using sodium-glucose transport protein 2 (SGLT2) inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors
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Key findings

Of 2,313 reports, 70.2% involved GLP-1 RAs; DPP-4 ROR 13.2 and GLP-1 ROR 9.65 were elevated; liraglutide had the highest GLP-1 association (ROR 6.83); ~17.7% of reports were serious.

Methodology

Researchers mined FAERS (2019–2021) for pancreatitis with GLP-1 RAs, DPP-4 inhibitors, and SGLT2 inhibitors, requiring concurrence of ROR, PRR, EBGM, and IC for a signal.

Limitations

Not incidence rates or proven causation—spontaneous reporting cannot adjust fully for indication, comorbidity, or reporting bias.

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