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.

中文翻译：

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Fournier的坏疽和钠葡萄糖共转运蛋白2抑制剂：一项随机对照试验的荟萃分析。

弗尼尔氏坏疽（FG）是一种罕见的会阴坏死性会阴筋膜炎。美国食品药品监督管理局（FDA）依靠FDA不良事件报告系统发布了有关与钠-葡萄糖共转运蛋白2抑制剂（SGLT2i）相关的FG风险的《药物安全通讯》。为了验证这种关联，我们对所有纳入2型糖尿病患者的随机对照试验进行了荟萃分析，将SGLT2i与安慰剂或不同疗法进行了比较，收集了报告为严重不良事件的FG病例。次要结果是脓肿，蜂窝织炎和丹毒的风险。我们检索了84个试验，SGLT2i组招募了42 415名患者，而比较组则招募了27 158名患者。SGLT2i与比较者之间在发生FG的风险方面未观察到差异（Mantel-Haenzel比值比[MH-OR] 0。