Empagliflozin Versus Dapagliflozin and Urogenital Adverse Events in Type 2 Diabetes: A Target Trial Emulation
Abstract
Aims: Urogenital adverse events are common with sodium-glucose co-transporter 2 inhibitors (SGLT2i) and may influence treatment decisions. Variations in SGLT2i selectivity, potency and effects on renal glucose excretion could lead to differences in safety profiles. We compared the risks of urinary tract infection (UTI), genital tract infection (GTI) and phimosis among adults with Type 2 diabetes who initiated empagliflozin versus dapagliflozin.
Materials and methods: This population-based, active-comparator, new-user cohort study emulating a target trial included adult metformin users initiating empagliflozin or dapagliflozin during 2015-2022. We identified UTIs and GTIs through pharmacy antimicrobial prescriptions and inpatient or outpatient diagnoses. Phimosis was identified through hospital diagnoses and procedure codes. Baseline characteristics were balanced using inverse probability of treatment weighting, and cumulative risks and risk ratios were estimated using an intention-to-treat approach.
Results: The study population included 53 083 empagliflozin and 33 349 dapagliflozin initiators, with median follow-up ranging from 2.6 to 3.8 years across outcomes. The weighted 1-year UTI risk was similar between groups (empagliflozin 10.3% vs. dapagliflozin 10.6%, RR 0.98 [95% CI, 0.95-1.01]). Risks of GTI (2.2% vs. 2.0%, RR 1.14 [95% CI, 1.04-1.25]), and phimosis (1.0% vs. 0.8%, RR 1.23 [95% CI, 1.04-1.52]) were slightly higher with empagliflozin, though absolute risk…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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