BackgroundIn EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) empagliflozin significantly reduced the risk of cardiovascular and kidney outcomes in patients with type 2 diabetes mellitus and established cardiovascular disease. Post hoc, we evaluated empagliflozin on kidney outcomes in patients with or without heart failure (HF).Methods and ResultsIndividuals were randomized to empagliflozin 10 mg, 25 mg, or placebo. Prespecified analyses by baseline HF status included risk of incident or worsening nephropathy and estimated glomerular filtration rate slope analyses. Cox proportional hazards models assessed consistency of treatment effect across subgroups. Safety evaluations included kidney-related adverse events. At baseline, 244 (10.5%) and 462 (9.9%) patients had HF in the placebo and empagliflozin groups, respectively. Overall, the incidence of kidney outcome events was numerically higher in patients with than without HF. In the HF group, empagliflozin reduced risk of incident or worsening nephropathy or cardiovascular death by 43% (hazard ratio, 0.57 [95% CI, 0.42–0.77]) and progression to macroalbuminuria by 50% (hazard ratio, 0.50 [0.33–0.75]). After an initial transient decrease, estimated glomerular filtration rate stabilized over time with empagliflozin but gradually declined with placebo. Kidney effects in patients with HF were consistent with those in the overall study population (all P values for interaction >0.05). Across groups, the incidence rate of kidney-related adverse events/100 patient-years was higher in patients with than without HF; however, overall rates were comparable between groups.ConclusionsThese findings from EMPA-REG OUTCOME support the hypothesis that empagliflozin could reduce the risk of clinically relevant kidney events and may slow progression of chronic kidney disease in individuals with type 2 diabetes mellitus regardless of HF status.Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01131676.

中文翻译：

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Empagliflozin改善有或没有心力衰竭患者的肾脏结局。

背景在EMPA-REG结果（2型糖尿病患者的恩格列净心血管事件事件试验）中，恩帕格列净显着降低了2型糖尿病和已确定的心血管疾病患者发生心血管和肾脏结局的风险。事后，我们评估了依帕格列净对有或没有心力衰竭（HF）患者的肾脏结局的影响。方法和结果将患者随机分为依帕格列净10 mg，25 mg或安慰剂。通过基线HF状态进行的预先分析包括发生肾病或肾病恶化的​​风险，以及估计的肾小球滤过率斜率分析。考克斯比例风险模型评估了各亚组治疗效果的一致性。安全性评估包括与肾脏有关的不良事件。基线时为244（10.5％）和462（9。安慰剂组和依帕列净组分别有9％的患者患有HF。总体而言，有HF的患者的肾结局事件的发生率在数字上高于无HF的患者。在心力衰竭组中，依帕格列净将发生或恶化的肾病或心血管死亡的风险降低了43％（危险比，0.57 [95％CI，0.42-0.77]），并发展为白蛋白尿减少了50％（危险比，0.50 [0.33-0.75] ]）。最初短暂下降后，依帕列净估计肾小球滤过率随时间稳定，但安慰剂逐渐下降。HF患者的肾脏影响与总体研究人群的肾脏影响一致（所有 依帕格列净将发生或恶化的肾病或心血管死亡的风险降低了43％（危险比，0.57 [95％CI，0.42-0.77]），并发展为白蛋白尿减少了50％（危险比，0.50 [0.33-0.75]）。最初的短暂下降后，依帕列净估计肾小球滤过率随时间稳定，但安慰剂逐渐下降。HF患者的肾脏影响与总体研究人群的肾脏影响一致（所有 依帕格列净将发生或恶化的肾病或心血管死亡的风险降低了43％（危险比，0.57 [95％CI，0.42-0.77]），并发展为白蛋白尿减少了50％（危险比，0.50 [0.33-0.75]）。最初短暂下降后，依帕列净估计肾小球滤过率随时间稳定，但安慰剂逐渐下降。HF患者的肾脏影响与总体研究人群的肾脏影响一致（所有相互作用的P值> 0.05）。在所有组中，有HF的患者肾相关不良事件的发生率/ 100患者-年高于没有HF的患者；结论EMPA-REG OUTCOME的这些发现支持了依帕列净可降低临床相关肾脏事件的风险，并可能减慢2型糖尿病患者慢性肾脏疾病进展的假设，而与HF状态无关。临床试验注册网址：https：//www.clinicaltrials.gov。唯一标识符：NCT01131676。