1596-P: Evaluating Reports of Pancreatic Malignancy and Liraglutide: A Pharmacovigilance Study of the FDA Adverse Event Reporting System

Background: Animal studies have raised concerns about glucagon-like peptide-1 (GLP-1) receptor agonist usage and incidence of pancreatic premalignant changes. Although randomized controlled Trials (RCTs) have not described this association, smaller size and shorter duration of RCTs may limit their statistical power to find such an association. Liraglutide utilization has been increasing due to the prescribing label change and indication for cardiovascular disease.

Aim: Evaluate reporting associations between pancreatic cancer and liraglutide using FDA Adverse Event Reporting System (FAERS).

Methods: FAERS reports from 1 January 2004 to 31 December 2018 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify pancreatic cancer cases. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (CIs) for the reporting associations among liraglutide, metformin, glyburide, glipizide, and empagliflozin and pancreatic cancer were calculated.

Results: A total of 10,015,622 reports were considered. Pancreatic cancer RORs (95% CI) in descending order were: Liraglutide 32.47 (30.53-34.52), metformin 6.85 (6.52-7.19), glyburide 5.24 (4.48-6.14), glipizide 3.83 (3.32-4.42), and empagliflozin 3.42 (2.50-4.67). The number of reports for pancreatic cancer increased from 2735 in 2010 to 4967 in 2018.

Conclusion: Liraglutide had greater reporting associations when compared to other antidiabetes medications. Further studies are needed to determine if this signal is causal.