Pneumatosis intestinalis associated with α-glucosidase inhibitors: a pharmacovigilance study of the FDA adverse event reporting system from 2004 to 2022

Abstract

Background: A-glucosidase inhibitors (AGIs) are suitable for type 2 diabetes mellitus patients with carbohydrate-rich diets while were reported associated with the rare but potentially life-threatening pneumatosis intestinalis (PI).

Research design and methods: Data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) were examined for AGIs, acarbose, voglibose, miglitol, or other anti-hyperglycemic drug classes. The reporting odds ratio (ROR), proportional reporting ratio, gamma poisson shrinker, and bayesian confidence propagation neural network were applied to determine the safety signals, which were performed under two other models to control for bias from type 2 diabetes mellitus and other anti-hyperglycemic drugs.

Results: We found a significantly higher reporting of PI in all AGIs group [ROR = 73.85 (61.56-88.58)]. When further subdivided, voglibose and miglitol had a larger ROR than acarbose whether models were adjusted or not. The safety signals of biguanides, sulfonylureas, thiazolidinediones, dipeptidyl peptidase 4 inhibitors inhibitors, glucagon-like peptide-1 receptor agonists, sodium-glucose co-transporter-2 inhibitors, and other drug classes were not detected in three models.

Conclusions: Our study identified the safety signals of the PI-AGIs pair, primarily based on disproportionality analysis while controlling for confounders such as the disease-associated risk of PI and concomitant drug exposure.

Keywords: FAERS; Pneumatosis intestinalis; disproportionality analysis; pharmacovigilance; α-glucosidase inhibitors.