Association of SGLT2 inhibitors and urogenital infections in patients attending a tertiary care hospital: a prospective observational study

Background: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are known for efficacy in managing blood sugar levels in type 2 diabetes and also improving cardiovascular and renal outcomes. However, increased risk of urogenital infections (UGIs) remains a significant concern in their safety profile. This study aimed to investigate the association between SGLT2i therapy and UGIs in a real-world clinical set up of a tertiary care centre in India. The key hypothesis was SGLT2i use is associated with incidence of UGIs while the secondary hypothesis included the relationship of the incidence of risk with the dose. Methods: This was a six-month prospective observational study, that enrolled 309 adults ≥18 years of age, who were newly prescribed SGLT2 inhibitors, particularly Dapagliflozin 5 mg and 10 mg from October 2023. The incidence of UGIs was assessed through patient interviews and medical records during the follow up from 2 weeks of initiation. UGIs were defined as clinical manifestations that resolved on SGLT2i discontinuation or appropriate treatment. Results: Of 309 initiators, 300 patients were followed up. 9 patients didn’t follow up in OPD. From these, 58 (19.3%) patients developed UGIs, comprising of 47 (15.6%) bacterial infections and 11 (3.6%) UGIs of fungal origin. The association was performed on basis of logistic regression analysis which revealed a statistically significant association of UGIs with the prescription of SGLT2i. Higher doses of SGLT2 inhibitors was observed to be associated with significantly increasing the risk of UGIs (p<0.05). No significant risk factors such as body mass index (BMI), age, sex, HbA1c or educational status were identified to have significant associations with UGI occurrence. Conclusions: This study highlights a clinically relevant association between SGLT2i use and urogenital infections.