J Am Soc Nephrol:恩格列净能“保护”2型糖尿病患者肾功能?

2018-11-20 吴星 环球医学网

EMPA-REG OUTCOME研究中,恩格列净成为首个在以心血管结局为主要终点的临床试验中显示可降低心血管死亡风险的2型糖尿病治疗药物。2018年11月,发表在《J Am Soc Nephrol》的EMPA-REG OUTCOME研究的坡度分析考查了,恩格列净对2型糖尿病患者肾功能的影响。

EMPA-REG OUTCOME研究中,恩格列净成为首个在以血管结局为主要终点的临床试验中显示可降低血管死亡风险的2型糖尿病治疗药物。2018年11月,发表在《J Am Soc Nephrol》的EMPA-REG OUTCOME研究的坡度分析考查了,恩格列净对2型糖尿病患者肾功能的影响。

背景:EMPA-REG OUTCOME研究显示,恩格列净延缓了合并心血管疾病的2型糖尿病患者CKD的进展。通过预先规定的的统计学方法,研究人员通过分析eGFR变化的斜率评估了肾功能的治疗差异。

方法:7020名参与者在标准治疗的基础上,按照1:1:1的比例随机分配到恩格列净10mg/d、恩格列净25mg/d或安慰剂组中。研究人员使用预先定义的研究周期的随机截距/随机系数模型计算了eGFR的斜率:包括治疗初始(自基线到第4周)、慢性维持治疗(第4周到治疗结束值)、治疗后(治疗结束值到随访)阶段。

结果:与安慰剂相比,恩格列净与所有周期个体eGFR斜率的均匀变化相关。治疗初始时,调整后的平均斜率(每周eGFR的变化,mL/min/1.73m2)随着恩格列净而降低(恩格列净:-0.77;95% CI,-0.83~-0.71;安慰剂:0.01;95% CI,-0.08~0.10;P<0.001)。然而,慢性维持治疗期年平均斜率(mL/min/1.73m2/年)不随恩格列净而降低(恩格列净:0.23;95% CI,0.05~0.40;安慰剂:-1.46;95% CI,-1.74~-1.17;P<0.001)。停药后,仅在恩格列净组发生调整后平均eGFR斜率(mL/min/1.73m2/周)增加,平均eGFR返回基线水平(恩格列净:0.56;95% CI,0.49~0.62;安慰剂:-0.02;95% CI,-0.12~0.08;P<0.001)。具有较高CKD风险亚组患者结果一致。

结论:与肾小球内压力降低相关的恩格列净血流动力学影响有助于长期保护肾功能。

原始出处:
Wanner C1, Heerspink HJL2, Zinman B3, et al.Empagliflozin and Kidney Function Decline in Patients with Type 2 Diabetes: A Slope Analysis from the EMPA-REG OUTCOME Trial.J Am Soc Nephrol. 2018 Nov;29(11):2755-2769. doi: 10.1681/ASN.2018010103. Epub 2018 Oct 12.

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    2019-02-19 yese
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    2018-11-20 misszhang

    谢谢MedSci提供最新的资讯

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