Comparative safety of hypoglycemic drugs: sodium-glucose cotransporter 2 inhibitors and dipeptidyl peptidase-4 inhibitors

The relevance of this study is driven by the increasing prevalence of type 2 diabetes mellitus and the need to evaluate the safety of modern hypoglycemic agents. The purpose of the study was to conduct a comparative analysis of post-marketing data from real-world clinical practice on the safety of SGLT2 inhibitors and DPP-4 inhibitors. Objectives: to establish the quantitative and qualitative characteristics of adverse reactions (ARs) to SGLT2 inhibitors and DPP-4 inhibitors. Materials and methods. A total of 80,521 cases related to SGLT2 inhibitors and 27,281 cases associated with DPP-4 inhibitors were recorded in the VigiBase global safety monitoring database of the Uppsala Monitoring Centre (UMC) under the WHO program for the period from January 1, 2021, to December 31, 2025. All cases were analyzed using a qualitative expert review method, using primary CIOMS case forms in VigiLyze (in PDF format) and official data from the State Register of Medicines. Reconciliation was performed using the MedDRA 28.1 classifier, taking into account the Score index. Reconciled cases were analyzed using routine PV tools: Causality Assessment (CA) and Signal Detection (SD) via qualitative methods. The main results showed significant differences in the safety profile of the studied drugs. Serious adverse reactions occurred in 47.4 % of cases with SGLT2 inhibitors, compared to 27.4 % with DPP-4 inhibitors. The most common adverse events for SGLT2 inhibitors were urinary tract infections (5.7 %), diabetic ketoacidosis (3.9 %), and weight loss (3.4 %). For DPP-4 inhibitors, dizziness (10.8 %), diarrhea (9.4 %), and pemphigoid (5.5 %) were common. The practical significance of the study lies in clarifying the safety data of modern hypoglycemic agents, which allows for the optimization of their use based on individual patient characteristics and comorbid conditions. The obtained results can be utilized to improve pharmacovigilance systems and enhance the quality of medical care for patients with diabetes.