Mp69-16 Assessing the Risk of Urinary Tract Infections Associated With Sglt2 Inhibitors in Men: A Vigibase Analysis

You have accessJournal of UrologyInfections/Inflammation/Cystic Disease of the Genitourinary Tract: Kidney & Bladder I (MP69)1 May 2024MP69-16 ASSESSING THE RISK OF URINARY TRACT INFECTIONS ASSOCIATED WITH SGLT2 INHIBITORS IN MEN: A VIGIBASE ANALYSIS Zhiyu Qian, Jonathan Song, Brian Tao, Boyuan Xiao, Dejan K. Filipas, Edoardo Beatrici, Daniel R. Stelzl, Muhieddine Labban, Benjamin J. Stone, Hari S. Iyer, Stuart R. Lipsitz, Alexander P. Cole, and Quoc-Dien Trinh Zhiyu QianZhiyu Qian , Jonathan SongJonathan Song , Brian TaoBrian Tao , Boyuan XiaoBoyuan Xiao , Dejan K. FilipasDejan K. Filipas , Edoardo BeatriciEdoardo Beatrici , Daniel R. StelzlDaniel R. Stelzl , Muhieddine LabbanMuhieddine Labban , Benjamin J. StoneBenjamin J. Stone , Hari S. IyerHari S. Iyer , Stuart R. LipsitzStuart R. Lipsitz , Alexander P. ColeAlexander P. Cole , and Quoc-Dien TrinhQuoc-Dien Trinh View All Author Informationhttps://doi.org/10.1097/01.JU.0001008892.86171.de.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Sodium-glucose co-transporter-2 (SGLT2) inhibitors are antidiabetic medications with cardiovascular and renal benefits. However, the risk of urinary tract infections (UTI) remains debated. No prior studies have used VigiBase to examine this risk, particularly in men with benign prostate hyperplasia (BPH), who are already vulnerable to UTIs. Our study aims to address these gaps. METHODS: Using a pharmacovigilance case-noncase design, we applied disproportionality analysis to examine UTI risks with SGLT2 inhibitors. Data were sourced from VigiBase, the world's largest individual case safety report database, for male patients. Association strength was evaluated via Reporting Odds Ratio (ROR), with increased UTI signals determined by the lower 5th percentile of the Empirical Bayes Estimator (EBE). Sensitivity analyses were stratified by age as a marker for BPH. Sensitivity analyses were stratified by age 65 as surrogate for BPH, to further explore the UTI risk in this specific population. RESULTS: Out of 22,526,856 men in Vigibase, 26,737 were found to be users of SGLT2 inhibitors. We also noted 61,748 reports of UTIs. Among the subset of men on SGLT2 inhibitors, 411 UTI cases were reported. Disproportionality analysis indicated a significant UTI signal, evidenced by a Reporting Odds Ratio (ROR) of 6.75 and a lower 5th percentile Empirical Bayes Estimator (EBE) of 6.78. Further sensitivity analyses demonstrated notable disproportionality signals for UTI risk in men younger than 65 years (ROR, 6.82; EBE, 6.99) as well as in those 65 years and older (ROR, 5.11; EBE, 5.44). CONCLUSIONS: In this pharmacovigilance study utilizing VigiBase, we examined the potential association between UTI risk and SGLT2 inhibitors. Our findings suggest a possible elevated UTI risk with these medications. Interestingly, being over the age of 65, often used as a surrogate for BPH, did not seem to further increase this risk. While SGLT2 inhibitors continue to gain traction as a preferred antidiabetic treatment, it would be prudent for providers to be aware of the potential UTI risk, especially in populations more susceptible to UTIs. Further studies are needed to corroborate these findings. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1125 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Zhiyu Qian More articles by this author Jonathan Song More articles by this author Brian Tao More articles by this author Boyuan Xiao More articles by this author Dejan K. Filipas More articles by this author Edoardo Beatrici More articles by this author Daniel R. Stelzl More articles by this author Muhieddine Labban More articles by this author Benjamin J. Stone More articles by this author Hari S. Iyer More articles by this author Stuart R. Lipsitz More articles by this author Alexander P. Cole More articles by this author Quoc-Dien Trinh More articles by this author Expand All Advertisement PDF downloadLoading ...