---
title: "SGLT2 inhibitors and urinary tract infection risk: trial-level meta-analysis across T2D, HF, and C"
id: "pubmed-42566081"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42566081"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42566081/"
doi: "10.1007/s40199-026-00637-7"
published_at: "2026-08-07T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# SGLT2 inhibitors and urinary tract infection risk: trial-level meta-analysis across T2D, HF, and C
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42566081
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42566081/)
- **DOI:** [10.1007/s40199-026-00637-7](https://doi.org/10.1007%2Fs40199-026-00637-7)
- **Published At:** 2026-08-07T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This trial-level meta-analysis assessed whether **SGLT2 inhibitors** increase risk of urinary tract infection (UTI) using randomized placebo-controlled trials of empagliflozin, dapagliflozin, canagliflozin, ertugliflozin, and bexagliflozin in adults with type 2 diabetes, chronic kidney disease, or heart failure. - Co-primary urinary safety outcomes were **any UTI** and **serious/complicated urinary infection** (defined by reported serious UTI endpoints or closest severe urinary phenotype). - Fourteen studies met inclusion criteria; 11 studies (62,542 participants, 4,685 events) contributed to the any-UTI analysis. - Pooled relative risk (RR) for any UTI across included trials was 1.14 (95% CI 0.99–1.32; P = 0.073) with substantial heterogeneity (I² = 76.0%). - A prespecified sensitivity analysis excluding reconstructed CANVAS estimates included 10 studies (52,400 participants, 4,019 events) and produced RR 1.08 (95% CI 1.00–1.18; P = 0.060) with lower heterogeneity (I² = 23.3%). - For serious/complicated urinary infection, 7 studies (34,396 participants, 339 events) were analyzed; pooled RR was 0.99 (95% CI 0.78–1.27; P = 0.960) with no detectable heterogeneity (I² = 0%). - No significant differences were observed across individual SGLT2 agents or by clinical population (type 2 diabetes, heart failure, chronic kidney disease). - Authors conclude there was no statistically significant increase in any UTI or serious/complicated UTI associated with SGLT2 inhibitors, supporting a distinction between lower-grade urinary events and clinically severe urinary infection, and noting urinary safety concerns differ from the established excess risk of external genital infection. - All statements, trial counts, and effect estimates are taken from the published abstract; further methodological details and individual trial data were not reported in the provided source.
## Clinical Analysis & Structured Key Points
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A trial-level meta-analysis across type 2 diabetes, heart failure, and chronic kidney disease [Andrea Matteucci](https://pubmed.ncbi.nlm.nih.gov/?term=Matteucci+A&cauthor_id=42566081)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#full-view-affiliation-1 "Ospedale San Filippo Neri, Rome, Italy. andrea.matteucci2@gmail.com."), [Stefania Angela Di Fusco](https://pubmed.ncbi.nlm.nih.gov/?term=Di+Fusco+SA&cauthor_id=42566081)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#full-view-affiliation-2 "Ospedale San Filippo Neri, Rome, Italy."), [Michela Bonanni](https://pubmed.ncbi.nlm.nih.gov/?term=Bonanni+M&cauthor_id=42566081)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#full-view-affiliation-3 "University of Rome Tor Vergata, Rome, Italy."), [Lorenzo Castello](https://pubmed.ncbi.nlm.nih.gov/?term=Castello+L&cauthor_id=42566081)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#full-view-affiliation-2 "Ospedale San Filippo Neri, Rome, Italy."), [Stefano Aquilani](https://pubmed.ncbi.nlm.nih.gov/?term=Aquilani+S&cauthor_id=42566081)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#full-view-affiliation-2 "Ospedale San Filippo Neri, Rome, Italy."), [Silvio Fedele](https://pubmed.ncbi.nlm.nih.gov/?term=Fedele+S&cauthor_id=42566081)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#full-view-affiliation-4 "Ospedale Sandro Pertini, Rome, Italy."), [Federico Nardi](https://pubmed.ncbi.nlm.nih.gov/?term=Nardi+F&cauthor_id=42566081)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#full-view-affiliation-5 "Santo Spirito Hospital, Casale Monferrato, Italy."), [Furio Colivicchi](https://pubmed.ncbi.nlm.nih.gov/?term=Colivicchi+F&cauthor_id=42566081)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#full-view-affiliation-2 "Ospedale San Filippo Neri, Rome, Italy.") Affiliations Expand ### Affiliations * 1 Ospedale San Filippo Neri, Rome, Italy. andrea.matteucci2@gmail.com. * 2 Ospedale San Filippo Neri, Rome, Italy. * 3 University of Rome Tor Vergata, Rome, Italy. * 4 Ospedale Sandro Pertini, Rome, Italy. * 5 Santo Spirito Hospital, Casale Monferrato, Italy. * PMID: **42566081** * DOI: [ 10.1007/s40199-026-00637-7 ](https://doi.org/10.1007/s40199-026-00637-7) Item in Clipboard Meta-Analysis # Are SGLT2 inhibitors really associated with increased urinary tract infection risk? A trial-level meta-analysis across type 2 diabetes, heart failure, and chronic kidney disease Andrea Matteucci et al. Daru. 2026. Show details Display options Display options Format Abstract PubMed PMID Daru Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Daru%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Daru%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42566081/) . 2026 Aug 7;34(2):56. doi: 10.1007/s40199-026-00637-7. ### Authors [Andrea Matteucci](https://pubmed.ncbi.nlm.nih.gov/?term=Matteucci+A&cauthor_id=42566081)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#short-view-affiliation-1 "Ospedale San Filippo Neri, Rome, Italy. andrea.matteucci2@gmail.com."), [Stefania Angela Di Fusco](https://pubmed.ncbi.nlm.nih.gov/?term=Di+Fusco+SA&cauthor_id=42566081)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#short-view-affiliation-2 "Ospedale San Filippo Neri, Rome, Italy."), [Michela Bonanni](https://pubmed.ncbi.nlm.nih.gov/?term=Bonanni+M&cauthor_id=42566081)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#short-view-affiliation-3 "University of Rome Tor Vergata, Rome, Italy."), [Lorenzo Castello](https://pubmed.ncbi.nlm.nih.gov/?term=Castello+L&cauthor_id=42566081)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#short-view-affiliation-2 "Ospedale San Filippo Neri, Rome, Italy."), [Stefano Aquilani](https://pubmed.ncbi.nlm.nih.gov/?term=Aquilani+S&cauthor_id=42566081)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#short-view-affiliation-2 "Ospedale San Filippo Neri, Rome, Italy."), [Silvio Fedele](https://pubmed.ncbi.nlm.nih.gov/?term=Fedele+S&cauthor_id=42566081)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#short-view-affiliation-4 "Ospedale Sandro Pertini, Rome, Italy."), [Federico Nardi](https://pubmed.ncbi.nlm.nih.gov/?term=Nardi+F&cauthor_id=42566081)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#short-view-affiliation-5 "Santo Spirito Hospital, Casale Monferrato, Italy."), [Furio Colivicchi](https://pubmed.ncbi.nlm.nih.gov/?term=Colivicchi+F&cauthor_id=42566081)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42566081/#short-view-affiliation-2 "Ospedale San Filippo Neri, Rome, Italy.") ### Affiliations * 1 Ospedale San Filippo Neri, Rome, Italy. andrea.matteucci2@gmail.com. * 2 Ospedale San Filippo Neri, Rome, Italy. * 3 University of Rome Tor Vergata, Rome, Italy. * 4 Ospedale Sandro Pertini, Rome, Italy. * 5 Santo Spirito Hospital, Casale Monferrato, Italy. * PMID: **42566081** * DOI: [ 10.1007/s40199-026-00637-7 ](https://doi.org/10.1007/s40199-026-00637-7) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Background:** Sodium-glucose cotransporter 2 (SGLT2) inhibitors are established therapies across the cardiovascular-renal continuum. Although the excess risk of external genital infection is well recognized, the association between SGLT2 inhibition and urinary tract infection (UTI), particularly serious/complicated urinary infection, remains uncertain. **Methods:** We conducted a systematic review and meta-analysis of randomized placebo-controlled trials of empagliflozin, dapagliflozin, canagliflozin, ertugliflozin, and bexagliflozin in adults with type 2 diabetes, chronic kidney disease, or heart failure. Co-primary urinary safety outcomes were any UTI and serious/complicated urinary infection, the latter defined using directly reported serious UTI endpoints or the closest reported severe urinary phenotype. Sensitivity analysis, subgroup analyses by drug and population, leave-one-out analyses, and exploratory meta-regression were performed. **Results:** A total of 14 studies were included. For the primary any-UTI analysis, 11 studies contributed data, comprising 62,542 participants and 4,685 events. SGLT2 inhibitors were associated with a pooled RR of 1.14 (95% CI 0.99-1.32; P = 0.073), with substantial heterogeneity (I²=76.0%). In the prespecified sensitivity analysis excluding reconstructed CANVAS estimates, 10 studies comprising 52,400 participants and 4,019 events yielded a pooled RR of 1.08 (95% CI 1.00-1.18; P = 0.060), with lower heterogeneity (I²=23.3%). For the serious/complicated urinary infection analysis, 7 studies comprising 34,396 participants and 339 events were available. The pooled RR was 0.99 (95% CI 0.78-1.27; P = 0.960), with no detectable heterogeneity (I²=0.0%). No significant subgroup differences were observed by individual SGLT2 inhibitor or by clinical population. **Conclusions:** SGLT2 inhibitors were not associated with a statistically significant increase in any UTI or serious/complicated UTI. These findings support a distinction between lower-grade urinary events and clinically severe urinary infection, and suggest that urinary safety concerns should not be considered equivalent to the established excess risk of external genital infection. **Keywords:** Chronic kidney disease; Heart failure; Meta-analysis; SGLT2 inhibitors; Severe urinary infection; Type 2 diabetes; Urinary tract infection. © 2026. The Author(s), under exclusive licence to Tehran University of Medical Sciences. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declarations. Ethical approval: This meta-analysis involves the use of previously published data, and no new data was collected directly from human subjects. As such, ethics approval was not required for this study. Competing interests: The authors declare no competing interests. ## References 1. 1. Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117–28. . - [DOI](https://doi.org/10.1056/nejmoa1504720) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/26378978/) 2. 1. McMurray JJV, Solomon SD, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Bělohlávek J, Böhm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukát A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O’Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjöstrand M, Langkilde AM. DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019;381(21):1995–2008. . Epub 2019 Sep 19. PMID: 31535829. - [DOI](https://doi.org/10.1056/nejmoa1911303) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/31535829/) 3. 1. Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020;383(15):1413–24. . - [DOI](https://doi.org/10.1056/nejmoa2022190) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/32865377/) 4. 1. Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Böhm M, et al. Empagliflozin in heart failure with a preserved ejection fraction. N Engl J Med. 2021;385(16):1451–61. . - [DOI](https://doi.org/10.1056/nejmoa2107038) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/34449189/) 5. 1. Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295–306. . - [DOI](https://doi.org/10.1056/nejmoa1811744) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/30990260/) Show all 34 references ## Publication types * Meta-Analysis Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Meta-Analysis%22%5Bpt%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Meta-Analysis) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42566081/) * Systematic Review Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Systematic+Review%22%5Bpt%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Systematic+Review) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42566081/) ## MeSH terms * Diabetes Mellitus, Type 2* / drug therapy Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Diabetes+Mellitus%2C+Type+2%2Fdrug+therapy%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Diabetes+Mellitus%2C+Type+2) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42566081/) * Heart Failure* / drug therapy Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Heart+Failure%2Fdrug+therapy%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Heart+Failure) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42566081/) * Humans Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Humans%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Humans) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42566081/) * Hypoglycemic Agents* / adverse effects Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Hypoglycemic+Agents%2Fadverse+effects%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Hypoglycemic+Agents) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42566081/) * Hypoglycemic Agents* / therapeutic use Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Hypoglycemic+Agents%2Ftherapeutic+use%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Hypoglycemic+Agents) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42566081/) * Randomized Controlled Trials as Topic Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Randomized+Controlled+Trials+as+Topic%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Randomized+Controlled+Trials+as+Topic) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42566081/) * Renal Insufficiency, Chronic* / drug therapy Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Renal+Insufficiency%2C+Chronic%2Fdrug+therapy%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Renal+Insufficiency%2C+Chronic) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42566081/) * Sodium-Glucose Transporter 2 Inhibitors* / adverse effects Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Sodium-Glucose+Transporter+2+Inhibitors%2Fadverse+effects%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Sodium-Glucose+Transporter+2+Inhibitors) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42566081/) * Urinary Tract Infections* / chemically induced Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Urinary+Tract+Infections%2Fchemically+induced%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Urinary+Trac
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