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恩格列净治疗慢性肾病可有效改善患者预后
作者:小柯机器人 发布时间:2022/11/13 20:02:53

英国牛津大学William G. Herrington团队研究了恩格列净治疗慢性肾脏病患者的疗效与安全性。2022年11月5日出版的《新英格兰医学杂志》发表了这项成果。

恩格列净对有疾病进展风险的慢性肾病患者的影响尚不清楚。该试验旨在评估恩格列净在广泛范围内治疗这类患者的效果。

研究组招募了估计肾小球滤过率(eGFR)至少为20但小于45mL/min/1.73m2体表面积的慢性肾病患者,或eGFR至少为45但小于90mL/min/1.73m2、尿白蛋白/肌酐比(白蛋白以mg计,肌酐以g计)至少为200的慢性肾脏疾病患者。患者被随机分配接受恩格列净(10 mg,每日一次)或匹配的安慰剂治疗。主要结局是肾病进展(定义为终末期肾病,eGFR持续下降10mL/min/1.73m2,eGFR较基线持续下降≥40%,或肾脏原因死亡)或心血管原因死亡。

共有6609名患者接受了随机分组。在中位数为2.0年的随访中,恩格列净组3304例患者中有432例(13.1%)发生肾脏疾病进展或心血管原因死亡,安慰剂组3305例患者中有558例(16.9%),危险比为0.72,组间差异显著。结果在患有或不患有糖尿病的患者之间以及根据eGFR范围定义的亚组之间是一致的。

恩格列净组全因住院率低于安慰剂组(危险比为0.86;组间差异显著),但在心力衰竭住院治疗或心血管原因死亡(恩格列净组为4.0%,安慰剂组为4.6%)或全因死亡(分别为4.5%和5.1%)的综合结局方面,组间无显著差异。两组严重不良事件的发生率相似。

研究结果表明,在许多有疾病进展风险的慢性肾脏病患者中,与安慰剂相比,恩格列净治疗导致肾脏疾病进展或心血管原因死亡的风险更低。

附:英文原文

Title: Empagliflozin in Patients with Chronic Kidney Disease | NEJM

Author: The EMPA-KIDNEY Collaborative Group

Issue&Volume: 2022-11-05

Abstract:

Background

The effects of empagliflozin in patients with chronic kidney disease who are at risk for disease progression are not well understood. The EMPA-KIDNEY trial was designed to assess the effects of treatment with empagliflozin in a broad range of such patients.

Methods

We enrolled patients with chronic kidney disease who had an estimated glomerular filtration rate (eGFR) of at least 20 but less than 45 ml per minute per 1.73 m2 of body-surface area, or who had an eGFR of at least 45 but less than 90 ml per minute per 1.73 m2 with a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of at least 200. Patients were randomly assigned to receive empagliflozin (10 mg once daily) or matching placebo. The primary outcome was a composite of progression of kidney disease (defined as end-stage kidney disease, a sustained decrease in eGFR to <10 ml per minute per 1.73 m2, a sustained decrease in eGFR of ≥40% from baseline, or death from renal causes) or death from cardiovascular causes.

Results

A total of 6609 patients underwent randomization. During a median of 2.0 years of follow-up, progression of kidney disease or death from cardiovascular causes occurred in 432 of 3304 patients (13.1%) in the empagliflozin group and in 558 of 3305 patients (16.9%) in the placebo group (hazard ratio, 0.72; 95% confidence interval [CI], 0.64 to 0.82; P<0.001). Results were consistent among patients with or without diabetes and across subgroups defined according to eGFR ranges. The rate of hospitalization from any cause was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.86; 95% CI, 0.78 to 0.95; P=0.003), but there were no significant between-group differences with respect to the composite outcome of hospitalization for heart failure or death from cardiovascular causes (which occurred in 4.0% in the empagliflozin group and 4.6% in the placebo group) or death from any cause (in 4.5% and 5.1%, respectively). The rates of serious adverse events were similar in the two groups.

Conclusions

Among a wide range of patients with chronic kidney disease who were at risk for disease progression, empagliflozin therapy led to a lower risk of progression of kidney disease or death from cardiovascular causes than placebo.

DOI: 10.1056/NEJMoa2204233

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2204233

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home