INSERM, Centre d'Investigation Clinique 9501 and Unité 961, and the Department of Cardiology, Nancy University, Nancy, France.
N Engl J Med. 2011 Jan 6;364(1):11-21. doi: 10.1056/NEJMoa1009492. Epub 2010 Nov 14.
Mineralocorticoid antagonists improve survival among patients with chronic, severe systolic heart failure and heart failure after myocardial infarction. We evaluated the effects of eplerenone in patients with chronic systolic heart failure and mild symptoms.
In this randomized, double-blind trial, we randomly assigned 2737 patients with New York Heart Association class II heart failure and an ejection fraction of no more than 35% to receive eplerenone (up to 50 mg daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure.
The trial was stopped prematurely, according to prespecified rules, after a median follow-up period of 21 months. The primary outcome occurred in 18.3% of patients in the eplerenone group as compared with 25.9% in the placebo group (hazard ratio, 0.63; 95% confidence interval [CI], 0.54 to 0.74; P<0.001). A total of 12.5% of patients receiving eplerenone and 15.5% of those receiving placebo died (hazard ratio, 0.76; 95% CI, 0.62 to 0.93; P=0.008); 10.8% and 13.5%, respectively, died of cardiovascular causes (hazard ratio, 0.76; 95% CI, 0.61 to 0.94; P=0.01). Hospitalizations for heart failure and for any cause were also reduced with eplerenone. A serum potassium level exceeding 5.5 mmol per liter occurred in 11.8% of patients in the eplerenone group and 7.2% of those in the placebo group (P<0.001).
Eplerenone, as compared with placebo, reduced both the risk of death and the risk of hospitalization among patients with systolic heart failure and mild symptoms. (Funded by Pfizer; ClinicalTrials.gov number, NCT00232180.).
醛固酮拮抗剂可改善慢性重度收缩性心力衰竭和心肌梗死后心力衰竭患者的生存率。我们评估了依普利酮在慢性收缩性心力衰竭和轻度症状患者中的作用。
在这项随机、双盲试验中，我们将 2737 名纽约心脏协会（NYHA）心功能 II 级且射血分数不超过 35%的患者随机分为依普利酮（最高每日 50mg）或安慰剂组，两组均接受推荐的治疗。主要终点是心血管原因死亡或心力衰竭住院的复合终点。
根据预先设定的规则，在中位随访 21 个月后提前终止了试验。依普利酮组患者的主要终点发生率为 18.3%，安慰剂组为 25.9%（风险比，0.63；95%置信区间[CI]，0.54 至 0.74；P<0.001）。依普利酮组共有 12.5%的患者死亡，安慰剂组为 15.5%（风险比，0.76；95%CI，0.62 至 0.93；P=0.008）；分别有 10.8%和 13.5%的患者死于心血管原因（风险比，0.76；95%CI，0.61 至 0.94；P=0.01）。心力衰竭和任何原因的住院治疗也因依普利酮而减少。依普利酮组血清钾水平超过 5.5mmol/L 的发生率为 11.8%，安慰剂组为 7.2%（P<0.001）。
与安慰剂相比，依普利酮可降低收缩性心力衰竭和轻度症状患者的死亡风险和住院风险。（由辉瑞公司资助；ClinicalTrials.gov 编号，NCT00232180。）
