Peripheral artery disease (PAD) is one of the most common cardiovascular complications in patients with type 2 diabetes mellitus (T2DM)1 and is a predictor of cardiovascular death.2 Interventions that reduce cardiovascular complications in this patient population are urgently required. In the EMPA-REG OUTCOME trial, the sodium glucose cotransporter 2 inhibitor empagliflozin reduced the risk of cardiovascular death by 38% (hazard ratio [HR], 0.62; 95% confidence interval [CI] 0.49–0.77]) and hospitalization for heart failure (HHF) by 35% (HR, 0.65; 95% CI, 0.50–0.85) versus placebo when given in addition to standard of care.3 We report analyses of the effects of empagliflozin on cardiovascular outcomes, mortality, and renal outcomes in patients with and without PAD at baseline in the EMPA-REG OUTCOME trial. Patients in EMPA-REG OUTCOME had T2DM (hemoglobin A1c, 7%–10%), established cardiovascular disease, and estimated glomerular filtration rate ≥30 mL·min−1·1.73 m−2 at baseline. PAD at inclusion was defined as the presence of any of the following: limb angioplasty, stenting, or bypass surgery; limb or foot amputation resulting from circulatory insufficiency; evidence of significant peripheral artery stenosis (>50% on angiography, or >50% or hemodynamically significant via noninvasive methods) in ≥1 limb; and ankle brachial index <0.9 in ≥1 ankle. Patients were randomized 1:1:1 to empagliflozin 10 mg, empagliflozin 25 mg, or placebo in addition to standard of care. Cardiovascular outcome events and deaths were prospectively adjudicated by Clinical Events committees. An independent ethics committee or institutional review board approved the clinical protocol at each participating center. Patients provided informed consent before study entry. In subgroups by PAD at baseline (yes/no), we assessed the …

中文翻译：

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依帕列净治疗2型糖尿病和周围动脉疾病患者的心血管结果和安全性

周围动脉疾病（PAD）是2型糖尿病（T2DM）1患者中最常见的心血管并发症之一，并且是心血管疾病死亡的预测指标。2迫切需要减少该患者人群心血管并发症的干预措施。在EMPA-REG OUTCOME试验中，钠葡萄糖共转运蛋白2抑制剂依帕格列净将心血管死亡的风险降低了38％（危险比[HR]，0.62； 95％置信区间[CI] 0.49-0.77]），并因心力衰竭住院（3）（HHF）与安慰剂相比，除标准治疗外给予安慰剂35％（HR，0.65; 95％CI，0.50–0.85）。3我们报告了依帕列净对患者心血管结局，死亡率和肾脏结局的影响分析在EMPA-REG OUTCOME试验中，在基线时使用PAD和不使用PAD。EMPA-REG结果的患者患有T2DM（血红蛋白A1c，7％–10％），确诊为心血管疾病，估计基线时肾小球滤过率≥30 mL·min-1·1.73 m-2。包括在内的PAD被定义为存在以下任何一种：肢体血管成形术，支架置入术或搭桥手术；循环不足引起的肢体或足部截肢；≥1条肢体有明显的外周动脉狭窄的证据（在血管造影术中> 50％，或通过无创方法> 50％或血液动力学显着）；踝肱指数<0.9且≥1。除护理标准外，将患者按1：1 1：1的比例随机分配至恩帕格列净10 mg，恩帕列净25 mg或安慰剂。临床事件委员会对心血管结局事件和死亡进行了前瞻性裁决。独立的伦理委员会或机构审查委员会批准了每个参与中心的临床方案。患者在进入研究前已获得知情同意。在基线时按PAD进行的亚组（是/否）中，我们评估了……