Comparative Incidence of Urinary Tract Infections in Diabetic Women Treated with Dapagliflozin Versus Empagliflozin: A Double-Blind Randomized Clinical Trial.

Abstract

Sodium-glucose cotransporter 2 (SGLT2) inhibitors, including dapagliflozin and empagliflozin, are widely used for glycemic control in type 2 diabetes but may affect the risk of urinary tract infection (UTI). This study compared the incidence of UTIs among women with diabetes treated with dapagliflozin versus empagliflozin. In this randomized, double-blind clinical trial, 149 diabetic women aged ≥ 18 years were assigned to receive dapagliflozin 5 mg (n = 79) or empagliflozin 10 mg (n = 70) daily for three months. Fasting blood sugar (FBS), glycated hemoglobin (HbA1c), and serum creatinine (Cr) were measured at baseline and after treatment. Urinalysis and urine culture were used to confirm UTIs. Data were analyzed using SPSS version 28.0, with P < 0.05 considered statistically significant. The mean age was 62.7 ± 9.7 years, with no baseline differences between groups. UTIs occurred in 12 patients overall: 2 (2.5%) in the dapagliflozin group and 10 (14.3%) in the empagliflozin group (OR = 0.16; 95% CI, 0.03 - 0.74; P = 0.009). No significant intergroup differences were observed in FBS, HbA1c, or Cr levels. Empagliflozin was associated with a higher short-term incidence of UTIs than dapagliflozin, despite similar metabolic outcomes. Monitoring for UTIs is recommended when prescribing SGLT2 inhibitors, particularly empagliflozin. Trial Registration: This trial is registered with the Iranian Registry of Clinical Trials (IRCT20250129064554N1).