Dapagliflozin in Patients with Chronic Kidney Disease
Dapagliflozin in Patients with Chronic Kidney Disease
复制标题
DOI：
10.1056/nejmoa2024816
复制
发表时间：
2020-10-08
影响因子：
158.5
通讯作者：
Wheeler, David C.
中科院分区：
文献类型：
--
作者：
Heerspink, Hiddo J. L.;Stefansson, Bergur V.;Wheeler, David C.
慢性肾脏病患者有很高的肾脏和心血管不良后果的风险。达格列净在慢性肾脏疾病患者中的作用，伴或不伴2型糖尿病，方法：我们随机分配了4304名参与者，他们的肾小球滤过率（GFR）估计值为25 - 75 ml/min/1.73 m2体表面积，尿白蛋白/肌酐比值（白蛋白以毫克测量，肌酸酐以克测量）200至5000的剂量接受达格列净（10 mg，每日一次）或安慰剂。主要结局是估计的GFR持续下降至少50%、终末期肾病或肾脏或心血管原因死亡的复合结果。结果独立数据监测委员会建议因疗效而停止试验。在中位数为2.4年的时间内，达格列净组2152例受试者中有197例（9.2%）发生主要结局事件，安慰剂组2152例受试者中有312例（14.5%）发生主要结局事件（风险比，0.61; 95%置信区间[CI]，0.51 - 0.72; P
BACKGROUNDPatients with chronic kidney disease have a high risk of adverse kidney and cardiovascular outcomes. The effect of dapagliflozin in patients with chronic kidney disease, with or without type 2 diabetes, is not known.METHODSWe randomly assigned 4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m(2) of body-surface area and a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin (10 mg once daily) or placebo. The primary outcome was a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes.RESULTSThe independent data monitoring committee recommended stopping the trial because of efficacy. Over a median of 2.4 years, a primary outcome event occurred in 197 of 2152 participants (9.2%) in the dapagliflozin group and 312 of 2152 participants (14.5%) in the placebo group (hazard ratio, 0.61; 95% confidence interval [CI], 0.51 to 0.72; P