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Fournier's gangrene and sodium‐glucose co‐transporter‐2 inhibitors: A meta‐analysis of randomized controlled trials
Author(s) -
Silverii Giovanni Antonio,
Dicembrini Ilaria,
Monami Matteo,
Mannucci Edoardo
Publication year - 2020
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.13900
Subject(s) - medicine , cellulitis , adverse effect , odds ratio , placebo , fasciitis , randomized controlled trial , confidence interval , surgery , pathology , alternative medicine
Fournier's gangrene (FG) is a rare, life‐threatening 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‐glucose co‐transporter‐2 inhibitors (SGLT2i), relying on the FDA Adverse Event Reporting System. To verify this association, we performed a meta‐analysis 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 42 415 patients in the SGLT2i group and 27 158 patients in comparator groups. No difference was observed between SGLT2i and comparators in the risk of FG (Mantel‐Haenzel odds ratio [MH‐OR] 0.41 [0.09, 1.82]), abscess (MH‐OR 0.94 [0.54, 1.65]), cellulitis (MH‐OR 0.90 [0.71, 1.13] or erysipela (MH‐OR 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.