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Genitourinary tract infections and SGLT2 inhibitors in heart failure: an EMPEROR-Pooled analysis

Ferreira JP, Zannad F, Butler J, Filippatos G, Vasques-Nóvoa F, Marques P, Neves JS, Anker SD et al.

European journal of heart failure, 2026

9,718 participants · 1 citation

Abstract

Aims: Sodium glucose co-transporter-2 inhibitors (SGLT2i) improve outcomes of patients with heart failure (HF). Urinary tract infections (UTI) are relatively common in HF, and their occurrence has been associated with an increased mortality risk. The use of SGLT2i has been associated with the occurrence of UTIs and mycotic genitourinary infections (MGI) which are a major cause of treatment discontinuation. This study aimed to study genitourinary infections in men and women with HF, their association with outcomes, and the impact of empagliflozin.

Methods: Analysis of EMPEROR-Pooled including a total of 9718 patients across the spectrum of ejection fraction. Descriptive statistics, Cox and time-varying survival models were used. The median follow-up time was 21 months.

Results: Throughout follow-up, 757 (7.8%) patients experienced a lower UTI, 60 (0.6%) MGI, and 41 pyelonephritis/urosepsis (0.4%). Genitourinary infections were more frequent in women than in men. Compared to patients without UTI/MGI, those with pyelonephritis/urosepsis were older and had higher comorbidity burden, whereas those with MGI were younger and had a higher prevalence of diabetes and obesity. Compared to placebo, empagliflozin was associated with a higher risk of lower UTI and MGI, particularly balanitis in men, but not pyelonephritis/urosepsis. The risk of death increased after UTI, but not after MGI. The effect of empagliflozin versus placebo on the composite of HF hospitalization or cardiovascular…

How strong is the evidence?

Evidence Hub reads this as a secondary / pooled analysis, 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. Reported size: 9,718 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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