SAT-537 The Safety Profile of Sodium-Glucose Co-transporter 2 Inhibitors in Type 2 Diabetes Mellitus With Special Reference to Genital Mycosis

Abstract Disclosure: B.K. Sethi: None. P.K. Ns: None. A. sonawane: None. S.S. Inamadar: None. M. Srivastava: None. S. Hussain: None. N. Ganguly: None. M. Tarannum: None. Introduction: SGLT2 inhibitors effectively manage type 2 diabetes mellitus (T2DM), lowering blood glucose and offering cardiorenal benefits. However, they can cause side effects like genital mycosis (GM), Urinary Tract Infections (UTIs), dehydration, and rarely euglycemic ketoacidosis. While clinical trials report varying incidences of these side effects ranging from 3% to 20% for genital mycosis, done across the world, their real-world frequency may differ. In this study we evaluated the safety profile of SGLT2 inhibitors. Materials and Methods: This was a prospective observational study, conducted at the out-patient department of a tertiary care center over a period of 6 months. We included patients aged ≥18 years with T2DM initiated on SGLT2 inhibitors. Patients were followed for 3 months to monitor adverse events. The sample size was 750 patients. Results: A total of 378 males and 372 females of age range 20-90 years were enrolled. The majority were prescribed Dapagliflozin (678), followed by Empagliflozin (61), Canagliflozin (4), and Remogliflozin (8). The most common adverse events were frequent urination (4.6%), UTIs (2.5%), GM (2.27%), joint and back pain (2.0%), and increased thirst (1.7%). Fewer patients experienced fatigue (0.5%) and ketoacidosis (0.1%). The side effect profile was consistent across all drugs, with a slightly higher incidence of genital mycosis in males (3.43%) versus females(1.34%). In the subgroup analysis the incidence of GM was found to be relatively lesser in those receiving the DPP4 inhibitors in addition to SGLT2 inhibitors. Most adverse events were managed symptomatically, with temporary drug discontinuation. Medication was discontinued for 8 patients with recurrent genital mycosis/ UTIs and 1 patient with euglycemic ketoacidosis. Discussion and Conclusion: SGLT2 inhibitors are generally well tolerated, with genital infections (GM) and urinary tract infections (UTIs) being the most common side effects, which often contribute to hesitancy in their initiation. However, our study observed a lower incidence of these adverse events, particularly when SGLT2 inhibitors were combined with DPP4 inhibitors, which is likely explained because of better glycemic control and immunomodulatory actions of DPP$ inhibitors decreasing the adhesion of fungi to the genital mucosa. Furthermore, most of the reported side effects were manageable. Therefore, the benefits of SGLT2 inhibitors outweigh the potential risks, supporting their safe use in appropriately selected patients with type 2 diabetes (T2DM). Presentation: Saturday, July 12, 2025