Risk of genitourinary tract infections with SGLT-2 inhibitors in type 2 diabetes mellitus: A meta-analysis of randomised controlled trials and disproportionality analysis using FAERS.

Background: Sodium-glucose cotransporter 2 inhibitors (SGLT-2is) manage type 2 diabetes mellitus (T2DM) via increased urinary glucose excretion; however, their use is associated with an elevated risk of genitourinary infections. This study aims to evaluate this risk by synthesizing evidence from randomized controlled trials (RCTs) and characterizing clinical features using data from the FDA Adverse Event Reporting System (FAERS).

Methods: In this systematic review and meta-analysis, we searched PubMed and Embase up to June 2024 for RCTs reporting genital mycotic infection (GMI) and urinary tract infection (UTI) events associated with SGLT-2is.