Same Class, Different Risk? Dapagliflozin versus Empagliflozin and Genitourinary Safety in Heart Failure with Preserved Ejection Fraction: A Retrospective Comparative Cohort Study
Razvan Alexandru Danau, Madalina Andreea Munteanu, Minerva Muraru, Camelia Nicolae, Gabriel Predoiu, Andreea Bardan, Viorel JingaAbstract
Background
Sodium–glucose cotransporter 2 inhibitors are guideline-directed therapy for heart failure with preserved ejection fraction (HFpEF), but comparative genitourinary safety data for dapagliflozin and empagliflozin in HFpEF-treated populations remain limited.
Objective
To compare 6-month symptomatic urinary tract infection (UTI), asymptomatic bacteriuria, and other genitourinary adverse events among patients newly initiated on dapagliflozin or empagliflozin for HFpEF.
Methods
This retrospective, single-centre comparative cohort study included 239 adults with physician-documented HFpEF retained after a requirement for at least 6 months of continuous follow-up: 113 received dapagliflozin 10 mg once daily and 126 received empagliflozin 10 mg once daily. The original outcome of any documented bacteriuria/UTI was separated into symptomatic UTI and asymptomatic bacteriuria. Risk differences and 95% confidence intervals were calculated; a multivariable logistic model of the original documented bacteriuria/UTI composite adjusted for age, sex, and baseline estimated glomerular filtration rate (eGFR).
Results
Any documented bacteriuria/UTI occurred in 21/113 (18.6%) dapagliflozin-treated participants and 25/126 (19.8%) empagliflozin-treated participants. Symptomatic UTI occurred in 4/113 (3.5%) and 5/126 (4.0%), respectively; 17/113 (15.0%) and 20/126 (15.9%) had documented asymptomatic bacteriuria. The risk difference for the composite, calculated as empagliflozin minus dapagliflozin, was 1.3 percentage points (95% CI −8.9 to 11.2). The adjusted odds ratio was 1.62 (95% CI 0.76–3.45; p = 0.208). Other genitourinary events were uncommon and estimates were imprecise.
Conclusions
No statistically detectable between-group difference was found in symptomatic UTI, asymptomatic bacteriuria, or the original composite outcome. Confidence intervals were wide and compatible with clinically meaningful differences in either direction. These exploratory findings require confirmation in prospective multicentre studies with standardized culture ascertainment and complete follow-up.