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Background <p>Sodium-glucose cotransporter 2 inhibitors (SGLT-2is) manage type 2 diabetes mellitus (T2DM) via increased urinary glucose excretion; however, their use is associated with an elevated risk of genitourinary infections. This study aims to evaluate this risk by synthesizing evidence from randomized controlled trials (RCTs) and characterizing clinical features using data from the FDA Adverse Event Reporting System (FAERS).</p> Methods <p>In this systematic review and meta-analysis, we searched PubMed and Embase up to June 2024 for RCTs reporting genital mycotic infection (GMI) and urinary tract infection (UTI) events associated with SGLT-2is. The primary outcome was the risk of GMI and UTI related to SGLT-2is, quantified using the risk ratio (RR) with a 95% confidence interval (CI). Additionally, a retrospective pharmacovigilance study of FAERS extracted the cases of genitourinary infections related to SGLT-2is up to June 2024. Disproportionality was calculated using the frequentist and bayesian based data mining algorithms.</p> Results <p>A total of 98 RCTs (91,756 participants) were included, treatment with SGLT-2is significantly increased the risk of GMI compared to placebo (RR: 3.65, 95% CI: 3.22- 4.14, <i>p</i> = &lt;0.0001) and active control (RR: 4.29; 95% CI: 3.42-5.38, <i>p</i> = &lt;0.0001). Subgroup analysis showed significant differences by individual drug, gender, and duration. Disproportionality analysis revealed significant signals for all SGLT-2is with genitourinary tract infections, persisting after signal refinement.</p> Conclusion <p>SGLT-2is significantly increase the risk of GMI among T2DM patients, while the association with UTI remains inconsistent. Additional research is required to elucidate the potential risk factors.</p>

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Risk of genitourinary tract infections with SGLT-2 inhibitors in type 2 diabetes mellitus: A meta-analysis of randomised controlled trials and disproportionality analysis using FAERS

  • 期刊论文

  • 发表日期：

    2025年8月24日

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  • Beema T Yoosuf,
  • Muhammed Favas KT,
  • Spoorthy D P,
  • Aasar Saini,
  • Prabha Garg,
  • Sanja Medenica,
  • Pinaki Dutta,
  • Dipika Bansal

摘要

Background

Sodium-glucose cotransporter 2 inhibitors (SGLT-2is) manage type 2 diabetes mellitus (T2DM) via increased urinary glucose excretion; however, their use is associated with an elevated risk of genitourinary infections. This study aims to evaluate this risk by synthesizing evidence from randomized controlled trials (RCTs) and characterizing clinical features using data from the FDA Adverse Event Reporting System (FAERS).

Methods

In this systematic review and meta-analysis, we searched PubMed and Embase up to June 2024 for RCTs reporting genital mycotic infection (GMI) and urinary tract infection (UTI) events associated with SGLT-2is. The primary outcome was the risk of GMI and UTI related to SGLT-2is, quantified using the risk ratio (RR) with a 95% confidence interval (CI). Additionally, a retrospective pharmacovigilance study of FAERS extracted the cases of genitourinary infections related to SGLT-2is up to June 2024. Disproportionality was calculated using the frequentist and bayesian based data mining algorithms.

Results

A total of 98 RCTs (91,756 participants) were included, treatment with SGLT-2is significantly increased the risk of GMI compared to placebo (RR: 3.65, 95% CI: 3.22- 4.14, p = <0.0001) and active control (RR: 4.29; 95% CI: 3.42-5.38, p = <0.0001). Subgroup analysis showed significant differences by individual drug, gender, and duration. Disproportionality analysis revealed significant signals for all SGLT-2is with genitourinary tract infections, persisting after signal refinement.

Conclusion

SGLT-2is significantly increase the risk of GMI among T2DM patients, while the association with UTI remains inconsistent. Additional research is required to elucidate the potential risk factors.