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. 2024 May 27:15:1364110.
doi: 10.3389/fphar.2024.1364110. eCollection 2024.

Pancreatitis with use of new diabetic medications: a real-world data study using the post-marketing FDA adverse event reporting system (FAERS) database

Khalidah A Alenzi  1   2 , Deemah Alsuhaibani  3 , Bader Batarfi  1 , Thamir M Alshammari  1   4   5
Affiliations

Pancreatitis with use of new diabetic medications: a real-world data study using the post-marketing FDA adverse event reporting system (FAERS) database

Khalidah A Alenzi et al. Front Pharmacol. .

Abstract

Background: Pancreatitis is characterized by inflammation of the pancreas and significantly affects quality of life. Less than 5% of pancreatitis cases are drug-induced, but recent evidence suggests a substantial risk associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The aim of this study was to 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. Methods: This study was done using the FDA Adverse Event Reporting System (FAERS) database from 2019 to 2021. This database contains information from diverse submissions from healthcare providers, patients, and manufacturers. To ensure fairness and accuracy, the risk of pancreatitis associated with other hypoglycemic agents (SGLT2 inhibitors and DPP-4 inhibitors) was also investigated. Traditional and Bayesian statistical analysis methods were used to identify disproportionate statistics and included the reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayes geometric mean (EBGM), and information component (IC). A drug-adverse-event combination that met the criteria of all four indices was deemed a signal. Results: The analysis of 2,313 pancreatitis reports linked to hypoglycemic agents revealed a predominant association with GLP-1 RA (70.2%) compared to DPP-4 inhibitors (15%) and SGLT2 (14.7%). Most of these reports involved female patients (50.4%), and the highest incidence occurred in those over 50 years old (38.4%). Additionally, 17.7% of the reports were associated with serious events. The ROR was significant for the risk of pancreatitis when using DPP-4 (13.2, 95% confidence interval (CI) 11.84-14.70), while the ROR for GLP-1 was 9.65 (95% CI 9.17-10.16). The EBGM was highest with DPP-4 (12.25), followed by GLP-1 (8.64), while IC was highest with DPP-4 inhibitors (3.61). Liraglutide had the greatest association with pancreatitis among the GLP-1 RAs (ROR: 6.83, 95% CI 6.60-7.07). Conclusion: The findings show that pancreatitis has a strong link with DPP-4 inhibitors and GPL1 agonists, which pose a greater risk. Among the GLP-1 agonist medications, liraglutide has been found to have an association with pancreatitis.

Keywords: drug-induced; glucagon-like peptide-1; inhibitors of dipeptidyl peptidase 4 (DPP-4); pancreatitis; sodium-glucose transport protein 2 (SGLT2) inhibitors.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Incidence of pancreatitis associated with glucagon-like peptide-1 receptor agonist across different age groups.
FIGURE 2
FIGURE 2
Pancreatitis incidence observed in glocagon-like peptide-1 receptor agonist users over a 3 years period.
FIGURE 3
FIGURE 3
Distribution of glucagon-like peptide-1 antaginist adverse event reports over the years.
FIGURE 4
FIGURE 4
Forecast global density distribution of pancreatitis cases associated with glucagon-like peptide-1 receptor agonists.
See this image and copyright information in PMC

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