{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T17:43:22Z","timestamp":1773251002299,"version":"3.50.1"},"reference-count":15,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,11,20]],"date-time":"2019-11-20T00:00:00Z","timestamp":1574208000000},"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":[[2020,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Fournier's gangrene (FG) is a rare, life\u2010threatening necrotizing fasciitis of the perineum. The US Food and Drug Administration (FDA) released a Drug Safety Communication regarding the risk of FG associated with sodium\u2010glucose co\u2010transporter\u20102 inhibitors (SGLT2i), relying on the FDA Adverse Event Reporting System. To verify this association, we performed a meta\u2010analysis of all randomized controlled trials enrolling patients with type 2 diabetes, comparing SGLT2i with placebo or different therapies, collecting cases of FG reported as a serious adverse event. Risk of abscess, cellulitis and erysipela were secondary outcomes. We retrieved 84 trials enrolling 42\u2009415 patients in the SGLT2i group and 27\u2009158 patients in comparator groups. No difference was observed between SGLT2i and comparators in the risk of FG (Mantel\u2010Haenzel odds ratio [MH\u2010OR] 0.41 [0.09, 1.82]), abscess (MH\u2010OR 0.94 [0.54, 1.65]), cellulitis (MH\u2010OR 0.90 [0.71, 1.13] or erysipela (MH\u2010OR 0.89 [0.45, 1.77]). The number of events was small, leading to a wide confidence interval that does not allow ruling out an increase in FG or skin and subcutaneous tissue infections.<\/jats:p>","DOI":"10.1111\/dom.13900","type":"journal-article","created":{"date-parts":[[2019,10,21]],"date-time":"2019-10-21T22:09:27Z","timestamp":1571695767000},"page":"272-275","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":43,"title":["Fournier's gangrene and sodium\u2010glucose co\u2010transporter\u20102 inhibitors: A meta\u2010analysis of randomized controlled trials"],"prefix":"10.1111","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6695-3213","authenticated-orcid":false,"given":"Giovanni Antonio","family":"Silverii","sequence":"first","affiliation":[{"name":"University of Florence, Clinical and Experimental Biomedical Sciences Department  Florence Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ilaria","family":"Dicembrini","sequence":"additional","affiliation":[{"name":"University of Florence, Clinical and Experimental Biomedical Sciences Department  Florence Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9349-828X","authenticated-orcid":false,"given":"Matteo","family":"Monami","sequence":"additional","affiliation":[{"name":"Diabetology Careggi Hospital  Florence Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edoardo","family":"Mannucci","sequence":"additional","affiliation":[{"name":"University of Florence, Clinical and Experimental Biomedical Sciences Department  Florence Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,11,20]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/CNQ.0000000000000055"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1159\/000445695"},{"key":"e_1_2_7_4_1","unstructured":"The U.S. Food and Drug Administration(2018). Drug safety communication: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes. Safety Announcement (August 29 2018)."},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/1753-0407.12896"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/dme.13508"},{"key":"e_1_2_7_7_1","unstructured":"Cecilia\u2010ChiW Lim\u2010TioS. Fournier's syndrome: a life threatening complication of SGLT2 inhibition in poorly controlled diabetes mellitus. Joint Annual Scientific Meeting of the Australian Diabetes Educators Association (ADEA) and Australian Diabetes; Aug 24\u2010262016 Gold Coast Queensland. Available at:http:\/\/ads-adea-2016.m.asnevents.com.au\/."},{"key":"e_1_2_7_8_1","first-page":"100","article-title":"Sodium\u2010glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin and Fournier's gangrene: a life threatening severe adverse outcome. Case report","volume":"35","author":"Omer T","year":"2018","journal-title":"Diabet Med"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-017-02733-w"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-151-4-200908180-00135"},{"key":"e_1_2_7_11_1","unstructured":"HCUP US(2018). Trend weights for HCUP NIS data.https:\/\/www.hcupus.ahrq.gov\/db\/nation\/nis\/trendwghts.jsp. Accessed December 25 2018."},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-008-0103-1"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1812389"},{"key":"e_1_2_7_14_1","first-page":"1094","article-title":"Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes","volume":"374","author":"Zinman B","year":"2016","journal-title":"N Engl J Med"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1611925"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.029190"}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dom.13900","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dom.13900","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/pdf\/10.1111\/dom.13900","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T06:42:50Z","timestamp":1761892970000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/10.1111\/dom.13900"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,11,20]]},"references-count":15,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,2]]}},"alternative-id":["10.1111\/dom.13900"],"URL":"https:\/\/doi.org\/10.1111\/dom.13900","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.1111\/DOM.13900\/v1\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v2\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v3\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v3\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v4\/response1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v3\/response1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v1\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v1\/review2","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v1\/review5","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v1\/review3","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v1\/review4","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v4\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v2\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13900\/v2\/response1","asserted-by":"object"}]},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"value":"1462-8902","type":"print"},{"value":"1463-1326","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,11,20]]},"assertion":[{"value":"2019-05-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-10-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-20","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}