{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T20:27:23Z","timestamp":1783974443341,"version":"3.55.0"},"reference-count":60,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2023,5,10]],"date-time":"2023-05-10T00:00:00Z","timestamp":1683676800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To assess whether the sodium\u2010glucose cotransporter\u20102 (SGLT2) inhibitor canagliflozin affects risk of non\u2010genital skin and soft tissue infections (SSTIs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>We performed a post hoc pooled individual participant analysis of the CANVAS Program and CREDENCE trials that randomized people with type 2 diabetes at high cardiovascular risk and\/or with chronic kidney disease to either canagliflozin or placebo. Investigator\u2010reported adverse events were assessed by two blinded authors following predetermined criteria for non\u2010genital SSTIs. Risks of non\u2010genital SSTIs, overall and within prespecified subgroups, and risk of non\u2010genital fungal SSTIs, were analysed using Cox regression models. Factors associated with non\u2010genital SSTIs were assessed using multivariable Cox regression models.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Overall, 903 of 14\u2009531 participants (6%) experienced non\u2010genital SSTIs over a median follow\u2010up of 26\u2009months. No difference was observed in non\u2010genital SSTI rates between canagliflozin and placebo (24.0 events\/1000 person\u2010years vs. 23.9 events\/1000 person\u2010years, respectively; hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.85\u20101.11;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.70), with consistent results across subgroups (all\n                      <jats:italic>P<\/jats:italic>\n                      interaction\u2009&gt;\u20090.05). The risk of recurrent events and non\u2010genital fungal infection also did not differ significantly between canagliflozin and placebo (HR 1.06, 95% CI 0.94\u20101.19 [\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.32] and HR 1.18, 95% CI 0.88\u20101.60 [\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.27], respectively). Baseline factors independently associated with non\u2010genital SSTIs were younger age, male sex, higher body mass index, higher glycated haemoglobin, lower estimated glomerular filtration rate (eGFR), established peripheral vascular disease, and history of neuropathy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Canagliflozin did not affect risk of non\u2010genital SSTIs or non\u2010genital fungal SSTIs compared with placebo. These findings suggest that any SGLT2 inhibitor\u2010mediated change in skin microenvironment is unlikely to have meaningful clinical consequences.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.15091","type":"journal-article","created":{"date-parts":[[2023,5,10]],"date-time":"2023-05-10T23:07:52Z","timestamp":1683760072000},"page":"2151-2162","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["<scp>The sodium\u2010glucose cotransporter\u20102<\/scp>\n                    inhibitor canagliflozin does not increase risk of non\u2010genital skin and soft tissue infections in people with type 2 diabetes mellitus: A pooled post hoc analysis from the\n                    <scp>CANVAS<\/scp>\n                    Program and\n                    <scp>CREDENCE<\/scp>\n                    randomized double\u2010blind trials"],"prefix":"10.1111","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0300-1282","authenticated-orcid":false,"given":"Amy","family":"Kang","sequence":"first","affiliation":[{"name":"The George Institute for Global Health University of New South Wales  Sydney New South Wales Australia"},{"name":"University of New South Wales  Sydney New South Wales Australia"},{"name":"Department of Nephrology Prince of Wales Hospital  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1838-3348","authenticated-orcid":false,"given":"Brendan","family":"Smyth","sequence":"additional","affiliation":[{"name":"The George Institute for Global Health University of New South Wales  Sydney New South Wales Australia"},{"name":"NHMRC Clinical Trials Centre University of Sydney  Sydney New South Wales Australia"},{"name":"Department of Renal Medicine St George Hospital  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9276-8380","authenticated-orcid":false,"given":"Brendon L.","family":"Neuen","sequence":"additional","affiliation":[{"name":"The George Institute for Global Health University of New South Wales  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3126-3730","authenticated-orcid":false,"given":"Hiddo J. 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