Pei Hui, Wang Wei, Zhao Di, Wang Lei, Su Guo-Hai, Zhao Zhuo
Shandong University Department of Cardiology, Shandong Provincial Chest Hospital Affiliated Hospital of Shandong Academy of Medical Sciences Department of Cardiology, Jinan Central Hospital Affiliated with Shandong University, Shandong, China.
Medicine (Baltimore). 2018 Apr;97(16):e0254. doi: 10.1097/MD.0000000000010254.
The non-steroidal mineralocorticoid receptor antagonist finerenone (BAY 94-8862) has been used to treat chronic heart failure (CHF) with reduced ejection fraction (HFrEF). However, conflicting results were reported for its efficacy and safety. The study aimed to compare the efficacy and safety of finerenone versus spironolactone or eplerenone in patients with chronic heart failure.
Electronic databases including MEDLINE, EMBASE, and CENTRAL were searched from inception to December 2017 for randomized controlled trials assessing finerenone treatment in patients with chronic heart failure. Data concerning the study's design, patients' characteristics, and outcomes were extracted. Risk ratio (RR) and mean differences (MD) were calculated using either fixed or random effects models.
Three trials with 1520 CHF patients were included in the systematic review. In terms of anti-ventricular remodeling, we calculated the effective number of cases with a 30% reduction in NT-proBNP. Finerenone was equivalent to the existing steroidal mineralocorticoid antagonist (P < .05). However, the efficacy of finerenone appeared to be dose-dependent. At a dose of 10 mg/d finerenone was found to be marginally better than that of steroidal mineralocorticoid receptor antagonists (MRAs) (RR = 1.18, 95% confidence interval [CI] 0.88, 1.57, P > .05). The incidence of treatment-related adverse events (TEAEs) of finerenone at 10 mg/d was significantly lower than 25 to 50 mg/d of steroidal MRAs (RR = 0.81, 95% CI = 0.66-0.99, P = .04). Moreover, the serum potassium levels in the finerenone 10 mg/d group were lower than those in the 25 to 50 mg/d steroidal MRAs group (MD = -0.14, 95% CI -0.30-0.02, P = .09), whereas the estimated glomerular filtration rate (eGFR) was higher in finerenone versus steroidal MRAs treated patients (MD = 2.07, 95% CI -0.04-4.17, P = .05).
Finerenone reduced NT-proBNP level, urinary albumin/creatinine ratio (UACR), and other biochemical indicators, in a dose-dependent manner. In terms of anti-ventricular remodeling in patient with chronic heart failure, finerenone at 10 mg/d is as effective as 20 to 50 mg/d of steroidal MRAs. However, finerenone is much safer to patients with chronic kidney disease.
非甾体类盐皮质激素受体拮抗剂非奈利酮（BAY 94-8862）已被用于治疗射血分数降低的慢性心力衰竭（CHF）。然而，关于其疗效和安全性的报道结果相互矛盾。本研究旨在比较非奈利酮与螺内酯或依普利酮在慢性心力衰竭患者中的疗效和安全性。
检索包括MEDLINE、EMBASE和CENTRAL在内的电子数据库，从建库至2017年12月，查找评估非奈利酮治疗慢性心力衰竭患者的随机对照试验。提取有关研究设计、患者特征和结局的数据。使用固定效应模型或随机效应模型计算风险比（RR）和均值差（MD）。
系统评价纳入了3项涉及1520例CHF患者的试验。在抗心室重构方面，我们计算了NT-proBNP降低30%的有效病例数。非奈利酮与现有的甾体类盐皮质激素拮抗剂相当（P<0.05）。然而，非奈利酮的疗效似乎呈剂量依赖性。在10mg/d的剂量下，发现非奈利酮略优于甾体类盐皮质激素受体拮抗剂（MRAs）（RR=1.18，95%置信区间[CI]0.88，1.57，P>0.05）。10mg/d的非奈利酮治疗相关不良事件（TEAE）的发生率显著低于25至50mg/d的甾体类MRAs（RR=0.81，95%CI=0.66-0.99，P=0.04）。此外，10mg/d非奈利酮组的血清钾水平低于25至50mg/d甾体类MRAs组（MD=-0.14，95%CI -0.30-0.02，P=0.09），而在接受非奈利酮治疗的患者中，估算肾小球滤过率（eGFR）高于接受甾体类MRAs治疗的患者（MD=2.07，95%CI -0.04-4.17，P=0.05）。
非奈利酮以剂量依赖的方式降低NT-proBNP水平、尿白蛋白/肌酐比值（UACR）和其他生化指标。在慢性心力衰竭患者的抗心室重构方面，10mg/d的非奈利酮与20至50mg/d的甾体类MRAs效果相当。然而，非奈利酮对慢性肾病患者更安全。
