Rationale, Design, and Baseline Characteristics of ARTS-DN: A Randomized Study to Assess the Safety and Efficacy of Finerenone in Patients with Type 2 Diabetes Mellitus and a Clinical Diagnosis of Diabetic Nephropathy
Rationale, Design, and Baseline Characteristics of ARTS-DN: A Randomized Study to Assess the Safety and Efficacy of Finerenone in Patients with Type 2 Diabetes Mellitus and a Clinical Diagnosis of Diabetic Nephropathy
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DOI：
10.1159/000371497
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发表时间：
2014-01-01
影响因子：
4.2
通讯作者：
Bakris, George L.
中科院分区：
文献类型：
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作者：
Ruilope, Luis M.;Agarwal, Rajiv;Bakris, George L.
背景/目的：非那瑞农可减少心力衰竭、射血分数降低和轻中度(2-3期)慢性肾脏疾病患者的蛋白尿。盐皮质激素受体拮抗剂耐受性研究-糖尿病肾病(ARTS-DN；NCT01874431)是一项多中心、随机、双盲、安慰剂对照、平行分组、2b期研究。ARTS-DN研究了盐皮质激素受体拮抗剂菲诺酮是否在不引起2型糖尿病患者血钾水平重大变化的情况下减少了蛋白尿，并对接受肾素-血管紧张素系统(RAS)抑制剂的糖尿病肾病进行了临床诊断。方法：患者被随机分为口服非那瑞酮1.25-20 mg或安慰剂，每天一次。主要目标是评估接受非那瑞酮治疗的患者在90天的尿白蛋白/肌酐比率与基线的比率，并将其与安慰剂组进行比较。其他探索性分析包括评估血钾水平、有效性和安全性生物标志物以及与健康相关的生活质量与基线的变化。结果：在筛选的1,501名患者中，821名(样本人群)接受了至少一剂非那瑞酮/安慰剂。基线特征包括：男性，77.8%；白人，84.2%；极高蛋白尿(以前的大量蛋白尿)，38.4%；高蛋白尿(以前的微量蛋白尿)，60.3%；估计肾小球滤过率的中位数(范围)，66.3(24.5-130.7)ml/分钟/1.73m(2)；以及收缩压(平均+/-标准差)，138.1+/-14.4 mm Hg。有心血管病史39.6%，有糖尿病神经病变20.0%，有糖尿病视网膜病变19.9%。结论：ARTS-DN是非那瑞酮联合RAS抑制剂治疗2型糖尿病患者的首个2b期试验，是糖尿病肾病的临床诊断。(C)2015年S.Karger AG，巴塞尔
Background/Aims: Finerenone decreases albuminuria in patients having heart failure with reduced ejection fraction and mild-to-moderate (stage 2-3) chronic kidney disease. The MinerAlocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN; NCT01874431) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2b study. ARTS-DN investigated whether the mineralocorticoid receptor antagonist finerenone reduces albuminuria without causing major alterations in serum potassium levels in patients with type 2 diabetes mellitus and a clinical diagnosis of DN who were receiving a renin-angiotensin-system (RAS) inhibitor. Methods: Patients were randomized to oral finerenone 1.25-20 mg or placebo once daily. The primary objectives were to assess the ratio of the urinary albumin-to-creatinine ratio at day 90 to that at baseline in patients receiving finerenone, and to compare it with that in the placebo group. Additional exploratory analyses included evaluating changes from baseline in serum potassium levels, efficacy and safety biomarkers, and health-related quality of life. Results: Of 1,501 patients screened, 821 (the sample population) received at least one dose of finerenone/placebo. Baseline characteristics included: male, 77.8%; white, 84.2%; very high albuminuria (formerly macroalbuminuria), 38.4%; high albuminuria (formerly microalbuminuria), 60.3%; median (range) estimated glomerular filtration rate, 66.3 (24.5-130.7) ml/min/1.73 m(2); and systolic blood pressure (mean +/- standard deviation), 138.1 +/- 14.4 mm Hg. There was a history of cardiovascular disease in 39.6%, diabetic neuropathy in 20.0%, and diabetic retinopathy in 19.9% of patients. Conclusion: ARTS-DN is the first phase 2b trial of finerenone in combination with a RAS inhibitor in patients with type 2 diabetes mellitus and a clinical diagnosis of DN. (C) 2015 S. Karger AG, Basel