Urinary tract infections and genital mycotic infections associated with SGLT‑2 inhibitors: an analysis of the FDA Adverse Event Reporting System

ABSTRACT

Background

Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are a class of antihyperglycemic agents, including canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. Risk of urinary tract infections (UTIs) and genital mycotic infections (GMIs) associated with SGLT‑2 inhibitors is of great clinical significance. The study aimed to assess the association between SGLT-2 inhibitors and occurrences of UTIs and GMIs using the FDA Adverse Event Reporting System (FAERS) database.

Methods

We used OpenVigil 2.1-MedDRA-v24 to query the FAERS database. Disproportionality analysis was performed to detect adverse event signals. Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) were calculated to measure the disproportionality.

Results

A total of 45,256 reports related to the use of SGLT-2 inhibitors, including 1,714 UTI cases and 438 GMI cases, were retrieved. Potential positive signals for UTIs and GMIs were identified for canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin in adult patients of all ages and both sexes.

Conclusions

Data mining in the FAERS database suggests strong association between SGLT-2 inhibitors and UTIs/GMIs. These findings provide real-world evidence on the potential risk of UTIs/GMIs related to SGLT-2 inhibitors.

KEYWORDS:

• Adverse event reporting system
• disproportionality analysis
• genital mycotic infections
• SGLT-2 inhibitors
• urinary tract infections

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Once reviewer received speaker fees at meetings indirectly supported by AstraZeneca. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Author contribution statement

T Yang and Y Cui were responsible for the conception and design of the research. T Yang was responsible for collecting and analyzing data. T Yang and Y Zhou were responsible for interpreting data. All authors participated in the drafting and revision of the manuscript, and agreed to submit the final version.

Additional information

Funding

This study was supported by grants National High-Level Hospital Clinical Research Funding (Scientific Research Seed Fund of Peking University First Hospital, No.2022SF87) and Clinical Pharmacy research project of Beijing Pharmaceutical Society (LCYX-2022-10).