Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes.
Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes.
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DOI：
10.1161/circulationaha.120.051898
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发表时间：
2021-02-09
期刊：
影响因子：
37.8
通讯作者：
FIDELIO-DKD Investigators
中科院分区：
文献类型：
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作者：
Filippatos G;Anker SD;Agarwal R;Pitt B;Ruilope LM;Rossing P;Kolkhof P;Schloemer P;Tornus I;Joseph A;Bakris GL;FIDELIO-DKD Investigators
文本中提供了补充数字内容。 FIDELIO-DKD 试验（Finerenone 减少糖尿病肾病肾衰竭和疾病进展）评估了非甾体选择性盐皮质激素受体拮抗剂 Finerenone 对优化肾素-血管紧张素系统阻断的慢性肾病和 2 型糖尿病患者的肾脏和心血管结局的影响。与安慰剂相比，finerenone 降低了综合肾脏和心血管结局。我们报告了 Finerenone 对个体心血管结局以及有或无动脉粥样硬化性心血管疾病 (CVD) 病史的患者的影响。这项随机、双盲、安慰剂对照试验纳入了 2 型糖尿病患者，尿白蛋白与肌酐比值为 30 至 5000 mg/g，估计肾小球滤过率≥25 至 <75 mL/min/1.73 m2，并接受优化的肾素-血管紧张素系统阻断治疗。有射血分数降低的心力衰竭病史的患者被排除在外。患者按照 1:1 的比例随机分配接受 Finerenone 或安慰剂治疗。复合心血管结局包括心血管死亡、心肌梗死、中风或因心力衰竭住院的时间。预先指定的心血管分析包括根据基线 CVD 病史对该复合材料的成分和结果进行分析。 2015年9月至2018年6月期间，对13911名患者进行了筛查，其中5674名患者被随机分组； 45.9% 的患者在基线时患有 CVD。在中位随访 2.6 年（四分位距，2.0-3.4 年）中，与安慰剂相比，finerenone 降低了复合心血管结局的风险（风险比，0.86 [95% CI，0.75-0.99]；P=0.034），患有和不患有 CVD 的患者之间没有显着的相互作用（风险比，0.85 [95% CI，有 CVD 病史的患者为 0.71-1.01；无 CVD 病史的患者风险比为 0.86 [95% CI，0.68-1.08]；交互作用的 P 值为 0.85）。治疗组之间治疗中出现的不良事件的发生率相似，高钾血症相关的永久性治疗终止的发生率较低（CVD 患者中，finerenone 组为 2.3%，安慰剂组为 0.8%；无 CVD 患者中，finerenone 组为 2.2%，安慰剂组为 1.0%）。在患有慢性肾病和 2 型糖尿病的患者中，finerenone 降低了复合心血管结局的发生率，没有证据表明治疗效果因先前存在的 CVD 状态而异。网址：https://www.clinicaltrials.gov；唯一标识符：NCT02540993。
Supplemental Digital Content is available in the text. The FIDELIO-DKD trial (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease) evaluated the effect of the nonsteroidal, selective mineralocorticoid receptor antagonist finerenone on kidney and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes with optimized renin–angiotensin system blockade. Compared with placebo, finerenone reduced the composite kidney and cardiovascular outcomes. We report the effect of finerenone on individual cardiovascular outcomes and in patients with and without history of atherosclerotic cardiovascular disease (CVD). This randomized, double-blind, placebo-controlled trial included patients with type 2 diabetes and urine albumin-to-creatinine ratio 30 to 5000 mg/g and an estimated glomerular filtration rate ≥25 to <75 mL per min per 1.73 m2, treated with optimized renin–angiotensin system blockade. Patients with a history of heart failure with reduced ejection fraction were excluded. Patients were randomized 1:1 to receive finerenone or placebo. The composite cardiovascular outcome included time to cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure. Prespecified cardiovascular analyses included analyses of the components of this composite and outcomes according to CVD history at baseline. Between September 2015 and June 2018, 13 911 patients were screened and 5674 were randomized; 45.9% of patients had CVD at baseline. Over a median follow-up of 2.6 years (interquartile range, 2.0–3.4 years), finerenone reduced the risk of the composite cardiovascular outcome compared with placebo (hazard ratio, 0.86 [95% CI, 0.75–0.99]; P=0.034), with no significant interaction between patients with and without CVD (hazard ratio, 0.85 [95% CI, 0.71–1.01] in patients with a history of CVD; hazard ratio, 0.86 [95% CI, 0.68–1.08] in patients without a history of CVD; P value for interaction, 0.85). The incidence of treatment-emergent adverse events was similar between treatment arms, with a low incidence of hyperkalemia-related permanent treatment discontinuation (2.3% with finerenone versus 0.8% with placebo in patients with CVD and 2.2% with finerenone versus 1.0% with placebo in patients without CVD). Among patients with chronic kidney disease and type 2 diabetes, finerenone reduced incidence of the composite cardiovascular outcome, with no evidence of differences in treatment effect based on preexisting CVD status. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02540993.