CLINICAL QUESTION

Do sodium-glucose cotransporter-2 (SGLT-2) inhibitors increase the risk of urogenital infections?

EVIDENCE-BASED ANSWER

Physicians should counsel adults treated with SGLT-2 inhibitors about an increased risk of urogenital infections. (Strength of Recommendation: A, meta-analysis of randomized controlled trials [RCTs].) Groups at highest risk include women, patients with obesity, and patients treated for 6 months or longer. There is also a small increase in the risk of urinary tract infection (UTI) in patients treated with SGLT-2 inhibitors. These medications do not appear to increase the risk of Fournier gangrene.

EVIDENCE SUMMARY

Urogenital Infections

A 2024 network meta-analysis evaluated the risk of urogenital infections in adults and compared SGLT-2 inhibitors with placebo or standard care. Of the 264 included studies, 62% specifically enrolled patients with type 2 diabetes. All but two studies included male and female patients. Patient mean ages ranged from 22 to 81 years.¹

The meta-analysis showed an increased risk of genital infections with SGLT-2 inhibitor treatment compared with placebo or standard care (188 trials; n = 121,275; odds ratio [OR] = 3.5; 95% CI, 3.1–3.9). Number needed to harm values across studies ranged between 16 and 31. There was a significantly lower risk of treatment-associated infections in male vs female patients (69 trials; n = 63,248; OR = 0.4; 95% CI, 0.4–0.5). In meta-regression analysis, a body mass index of 30 kg/m² or greater (compared with a body mass index less than 25 kg/m²; OR = 3.3; 95% CI, 1.1–10.3) and use of SGLT-2 inhibitor therapy for 6 months or longer (compared with less than 6 months; OR = 1.7; 95% CI, 1.3–2.3) appeared to increase the risk of treatment-related genital infection.¹