Sodium-glucose co-transporter-2 inhibitors (SGLT2i) improve outcomes in heart failure (HF), but concerns remain regarding genitourinary infections. This analysis published in the European Journal of Heart Failure examined the incidence of urinary tract infections (UTI) and mycotic genitourinary infections (MGI), their association with outcomes, and the impact of empagliflozin using data from EMPEROR-Pooled.

The pooled dataset included 9,718 patients across the ejection fraction spectrum, with a median follow-up of 21 months. During follow-up, 757 patients (7.8%) developed lower UTI, 60 (0.6%) MGI, and 41 (0.4%) pyelonephritis or urosepsis. Genitourinary infections were more common in women. Patients with pyelonephritis or urosepsis were older and had greater comorbidity burden, whereas those with MGI were younger and more likely to have diabetes and obesity.

Compared with placebo, empagliflozin was associated with higher risks of lower UTI and MGI, particularly balanitis in men, but not with increased pyelonephritis or urosepsis. The risk of death increased after UTI but not after MGI. Importantly, the treatment effect of empagliflozin on the composite of HF hospitalization or cardiovascular death was not modified by the occurrence of genitourinary infections.

Lower UTI occurred relatively frequently in HF, whereas serious infections were uncommon. The clinical benefits of SGLT2i were preserved regardless of genitourinary infection occurrence.