Risk of genital and urinary tract infections associated with SGLT‐2 inhibitors as an add‐on therapy to metformin in patients with type 2 diabetes mellitus: A retrospective cohort study in Korea

Abstract Sodium‐glucose cotransporter‐2 (SGLT‐2) inhibitors are antidiabetic drugs with associated safety concerns regarding the risk of genital and urinary tract infections. This study assessed the risk of genital and urinary tract infections associated with prescription of SGLT‐2 inhibitors as an...

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Main Authors: Hyeri Yang, Eunmi Choi, Eunjun Park, Eonji Na, Soo Youn Chung, Bonggi Kim, Soon Young Han
Format: Article
Language:English
Published: Wiley 2022-02-01
Series:Pharmacology Research & Perspectives
Subjects:
Online Access:https://doi.org/10.1002/prp2.910
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author Hyeri Yang
Eunmi Choi
Eunjun Park
Eonji Na
Soo Youn Chung
Bonggi Kim
Soon Young Han
author_facet Hyeri Yang
Eunmi Choi
Eunjun Park
Eonji Na
Soo Youn Chung
Bonggi Kim
Soon Young Han
author_sort Hyeri Yang
collection DOAJ
description Abstract Sodium‐glucose cotransporter‐2 (SGLT‐2) inhibitors are antidiabetic drugs with associated safety concerns regarding the risk of genital and urinary tract infections. This study assessed the risk of genital and urinary tract infections associated with prescription of SGLT‐2 inhibitors as an add‐on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) compared to dipeptidyl peptidase‐4 (DPP‐4) inhibitors, sulfonylurea (SU), and thiazolidinedione (TZD). We conducted a retrospective cohort study using the NHIS—National Health Insurance—Database in Korea from 2014 to 2017. Patients aged ≥19 years and those diagnosed with T2DM prior to drug prescription were enrolled. The outcomes were genital and urinary tract infections. Analysis was performed using Cox's proportional hazard model following 1:1 propensity score matching to calculate the hazard ratio (HR) with a 95% confidence interval (CI). Among the 107 131 patients included in the study, a total of 7738, 7145, and 2175 patients were assigned to the DPP‐4 inhibitors, SU, and TZD comparator groups, using the propensity score (PS) of each comparator based on 7741 people in the assessed drug SGLT‐2 inhibitor group. SGLT‐2 inhibitors were associated with a higher risk of genital infections than DPP‐4 inhibitors (HR: 2.39, 95% CI: 2.07–2.76), SU (HR: 3.23, 95% CI: 2.73–3.81), and TZD (HR: 3.23, 95% CI: 2.35–4.44), as an add‐on therapy to metformin. Similar results were observed for the risk of urinary tract infections. In conclusion, SGLT‐2 inhibitors are significantly associated with a higher risk of genital and urinary tract infections compared to DPP‐4 inhibitors, SU, and TZD.
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spelling doaj.art-8991af22f0e94566a47375f326272b712022-12-21T17:24:48ZengWileyPharmacology Research & Perspectives2052-17072022-02-01101n/an/a10.1002/prp2.910Risk of genital and urinary tract infections associated with SGLT‐2 inhibitors as an add‐on therapy to metformin in patients with type 2 diabetes mellitus: A retrospective cohort study in KoreaHyeri Yang0Eunmi Choi1Eunjun Park2Eonji Na3Soo Youn Chung4Bonggi Kim5Soon Young Han6Department of Drug Safety Information Korea Institute of Drug Safety and Risk Management Gyeonggi‐do Republic of KoreaDepartment of Drug Safety Information Korea Institute of Drug Safety and Risk Management Gyeonggi‐do Republic of KoreaDepartment of Drug Safety Information Korea Institute of Drug Safety and Risk Management Gyeonggi‐do Republic of KoreaDepartment of Drug Safety Information Korea Institute of Drug Safety and Risk Management Gyeonggi‐do Republic of KoreaDepartment of Drug Safety Information Korea Institute of Drug Safety and Risk Management Gyeonggi‐do Republic of KoreaDepartment of Drug Safety Information Korea Institute of Drug Safety and Risk Management Gyeonggi‐do Republic of KoreaDepartment of Drug Safety Information Korea Institute of Drug Safety and Risk Management Gyeonggi‐do Republic of KoreaAbstract Sodium‐glucose cotransporter‐2 (SGLT‐2) inhibitors are antidiabetic drugs with associated safety concerns regarding the risk of genital and urinary tract infections. This study assessed the risk of genital and urinary tract infections associated with prescription of SGLT‐2 inhibitors as an add‐on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) compared to dipeptidyl peptidase‐4 (DPP‐4) inhibitors, sulfonylurea (SU), and thiazolidinedione (TZD). We conducted a retrospective cohort study using the NHIS—National Health Insurance—Database in Korea from 2014 to 2017. Patients aged ≥19 years and those diagnosed with T2DM prior to drug prescription were enrolled. The outcomes were genital and urinary tract infections. Analysis was performed using Cox's proportional hazard model following 1:1 propensity score matching to calculate the hazard ratio (HR) with a 95% confidence interval (CI). Among the 107 131 patients included in the study, a total of 7738, 7145, and 2175 patients were assigned to the DPP‐4 inhibitors, SU, and TZD comparator groups, using the propensity score (PS) of each comparator based on 7741 people in the assessed drug SGLT‐2 inhibitor group. SGLT‐2 inhibitors were associated with a higher risk of genital infections than DPP‐4 inhibitors (HR: 2.39, 95% CI: 2.07–2.76), SU (HR: 3.23, 95% CI: 2.73–3.81), and TZD (HR: 3.23, 95% CI: 2.35–4.44), as an add‐on therapy to metformin. Similar results were observed for the risk of urinary tract infections. In conclusion, SGLT‐2 inhibitors are significantly associated with a higher risk of genital and urinary tract infections compared to DPP‐4 inhibitors, SU, and TZD.https://doi.org/10.1002/prp2.910genital infectionSGLT‐2 inhibitorstype 2 diabetes mellitusurinary tract infection
spellingShingle Hyeri Yang
Eunmi Choi
Eunjun Park
Eonji Na
Soo Youn Chung
Bonggi Kim
Soon Young Han
Risk of genital and urinary tract infections associated with SGLT‐2 inhibitors as an add‐on therapy to metformin in patients with type 2 diabetes mellitus: A retrospective cohort study in Korea
Pharmacology Research & Perspectives
genital infection
SGLT‐2 inhibitors
type 2 diabetes mellitus
urinary tract infection
title Risk of genital and urinary tract infections associated with SGLT‐2 inhibitors as an add‐on therapy to metformin in patients with type 2 diabetes mellitus: A retrospective cohort study in Korea
title_full Risk of genital and urinary tract infections associated with SGLT‐2 inhibitors as an add‐on therapy to metformin in patients with type 2 diabetes mellitus: A retrospective cohort study in Korea
title_fullStr Risk of genital and urinary tract infections associated with SGLT‐2 inhibitors as an add‐on therapy to metformin in patients with type 2 diabetes mellitus: A retrospective cohort study in Korea
title_full_unstemmed Risk of genital and urinary tract infections associated with SGLT‐2 inhibitors as an add‐on therapy to metformin in patients with type 2 diabetes mellitus: A retrospective cohort study in Korea
title_short Risk of genital and urinary tract infections associated with SGLT‐2 inhibitors as an add‐on therapy to metformin in patients with type 2 diabetes mellitus: A retrospective cohort study in Korea
title_sort risk of genital and urinary tract infections associated with sglt 2 inhibitors as an add on therapy to metformin in patients with type 2 diabetes mellitus a retrospective cohort study in korea
topic genital infection
SGLT‐2 inhibitors
type 2 diabetes mellitus
urinary tract infection
url https://doi.org/10.1002/prp2.910
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