SGLT2 Inhibitor and Urinary Tract Infection in Men at Risk for Voiding Dysfunction: A VigiBase Analysis

Area of Science:

• Pharmacovigilance and Drug Safety
• Urology and Nephrology
• Endocrinology and Diabetes Management

Background:

• Sodium-glucose cotransporter-2 (SGLT2) inhibitors are widely used for managing type 2 diabetes.
• Male patients, particularly older individuals, may be at increased risk for urinary tract infections (UTIs) due to potential voiding dysfunction.
• Understanding the specific risks associated with SGLT2 inhibitors in men is crucial for safe prescribing.

Purpose of the Study:

• To investigate the association between SGLT2 inhibitor use and the risk of urinary tract infections (UTIs) and complex UTIs in men.
• To specifically evaluate this risk in older men (≥65 years) who are more susceptible to voiding dysfunction.

Main Methods:

• A pharmacovigilance case-noncase study design was employed using global VigiBase reports (1967–2022).
• Disproportionality analysis, including Reporting Odds Ratio (ROR) and Empirical Bayes Estimator (EBE), was used to assess the risk.
• Age stratification at 65 years and sensitivity analyses comparing SGLT2 inhibitors with other diabetes medications were conducted.

Main Results:

• An elevated risk for both UTIs (ROR 6.75) and complex UTIs (ROR 8.09) was observed in men using SGLT2 inhibitors.
• In men aged 65 and over, the risk for complex UTIs was particularly pronounced (ROR 8.79).
• Sensitivity analyses confirmed significant associations, indicating consistent safety signals.

Conclusions:

• SGLT2 inhibitors are associated with an increased risk of UTIs and complex UTIs in the male population.
• Older men, potentially with benign prostatic hyperplasia-related voiding dysfunction, exhibit a more pronounced risk for complex UTIs.
• Prescribers should consider a balanced risk-benefit assessment when initiating SGLT2 inhibitors, especially in susceptible male populations.