达格列净在接受盐皮质激素受体拮抗剂治疗的射血分数降低心衰（HFrEF）患者中的应用：DAPA-HF 分析。
Dapagliflozin in HFrEF Patients Treated With Mineralocorticoid Receptor Antagonists: An Analysis of DAPA-HF.
机构信息
Department of Medicine, Hangzhou Normal University, Hangzhou, China; BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.
BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom; Department of Cardiology, Rigshospitalet University Hospital, Copenhagen, Denmark.
出版信息
JACC Heart Fail. 2021 Apr;9(4):254-264. doi: 10.1016/j.jchf.2020.11.009. Epub 2021 Feb 3.
OBJECTIVES
The purpose of this study was to assess the efficacy and safety of dapagliflozin in patients taking or not taking an mineralocorticoid receptor antagonist (MRA) at baseline in the DAPA-HF (Dapagliflozin And Prevention of Adverse outcomes in Heart Failure) trial.
BACKGROUND
MRAs and sodium glucose co-transporter 2 inhibitors each have diuretic activity, lower blood pressure, and reduce glomerular filtration rate (GFR). Therefore, it is important to investigate the safety, as well as efficacy, of their combination.
METHODS
A total of 4,744 patients with heart failure with reduced ejection fraction (HFrEF) were randomized to placebo or dapagliflozin 10 mg daily. The efficacy of dapagliflozin on the primary composite outcome (cardiovascular death or episode of worsening heart failure) and its components was examined according to MRA use, as were predefined safety outcomes.
RESULTS
A total of 3,370 patients (71%) were treated with an MRA and they were younger (65 vs. 69 years of age), less often from North America (9% vs. 26%), had worse New York Heart Association functional class (35% vs. 25% in class III/IV), lower left ventricular ejection fraction (30.7% vs. 31.9%) and systolic blood pressure (120.3 vs. 125.5 mm Hg), but higher estimated GFR (67.1 vs. 62.6 ml/min/1.73 m), than patients not taking an MRA. The benefit of dapagliflozin compared with placebo was similar in patients taking or not taking an MRA: hazard ratio: 0.74 (95% confidence interval [CI]: 0.63 to 0.87) versus 0.74 (95% CI: 0.57 to 0.95), respectively, for the primary endpoint (p value for interaction = 0.97); similar findings were observed for secondary endpoints. In both MRA subgroups, safety outcomes were similar in patients randomized to dapagliflozin or placebo.
CONCLUSIONS
Dapagliflozin was similarly efficacious and safe in patients with HFrEF taking or not taking an MRA, supporting the use of both drugs together. (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure [DAPA-HF]; NCT03036124).
目的
本研究旨在评估达格列净在基线时服用或未服用盐皮质激素受体拮抗剂（MRA）的心力衰竭患者中的疗效和安全性。
背景
MRA 和钠-葡萄糖共转运蛋白 2 抑制剂均具有利尿作用、降低血压和降低肾小球滤过率（GFR）。因此，重要的是要研究它们联合使用的安全性和疗效。
方法
共有 4744 名射血分数降低的心力衰竭（HFrEF）患者被随机分配至安慰剂或每日 10mg 达格列净组。根据 MRA 使用情况，检查达格列净对主要复合终点（心血管死亡或心力衰竭恶化事件）及其组成部分的疗效，以及预先设定的安全性结局。
结果
共有 3370 名患者（71%）接受 MRA 治疗，他们年龄更小（65 岁 vs. 69 岁），较少来自北美（9% vs. 26%），纽约心脏协会心功能分级更差（35% vs. 25%在 III/IV 级），左心室射血分数更低（30.7% vs. 31.9%）和收缩压更低（120.3 毫米汞柱 vs. 125.5 毫米汞柱），但估算肾小球滤过率更高（67.1 毫升/分钟/1.73 平方米 vs. 62.6 毫升/分钟/1.73 平方米），与未服用 MRA 的患者相比。与安慰剂相比，达格列净的获益在服用或不服用 MRA 的患者中相似：风险比：0.74（95%置信区间[CI]：0.63 至 0.87）与 0.74（95%CI：0.57 至 0.95），分别为主要终点（p 值交互作用=0.97）；次要终点也观察到类似的发现。在 MRA 亚组中，与安慰剂相比，随机分配至达格列净或安慰剂的患者安全性结局相似。
结论
在服用或不服用 MRA 的 HFrEF 患者中，达格列净同样有效且安全，支持这两种药物联合使用。（评估达格列净对慢性心力衰竭患者恶化心力衰竭或心血管死亡发生率影响的研究 [DAPA-HF]；NCT03036124）。
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