Results
Pancreatic and gallbladder AEs were reported infrequently in RCTs. Pancreatitis was reported in 11 participants across five RCTs, with study-specific frequencies ranging from 0.2% (3 of 1,896) to 3.7% (1 of 27), while cholelithiasis was reported in 73 participants across 11 RCTs, with frequencies ranging from 0.3% (1 of 335 and 1 of 364) to 3.7% (1 of 27). Among observational studies, pancreatitis was reported in three studies, with proportions of 0.6% (63/10,002), 0.9% (1/110), and 2.1% (5,882/280,094). One retrospective cohort study reported an incidence rate of 3.84 events per 1,000 person-years among 9,193 participants, while cholelithiasis was reported at 11.89 events per 1,000 person-years in the same cohort. In the EudraVigilance pharmacovigilance analysis, pancreatitis represented 363 reported AEs (6.3% of all AEs and 19.4% of gastrointestinal AEs). In the FAERS database, pancreatitis accounted for 155/288 pancreatic-related reports [53.8%] and cholelithiasis for 143/249 gallbladder-related reports [57.4%]. Four case reports described six distinct AEs: edematous pancreatitis, acute pancreatitis, pancreatitis necrotizing, acalculous cholecystitis, gallstones, and gallbladder wall thickening, each reported once. Female participants, White participants, adults aged 18-64 years, and participants from the United States (US) predominated among reported demographic characteristics; however, demographic characteristics and comorbidity profiles were inconsistently reported and varied across studies.
