• shareshare
  • link
  • cite
  • add
auto_awesome_motion View all 5 versions
Publication . Article . Other literature type . 2011

Eplerenone in patients with systolic heart failure and mild symptoms

Gilles De Keulenaer; Ines Monte; Zuzana Motovska; Jaromir Hradec; Roman Leischik; Patrick Jourdain; Hans Prozesky; +8 Authors
Open Access

A B S T R AC T BACKGROUND Mineralocorticoid antagonists improve survival among patients with chronic, se- vere systolic heart failure and heart failure after myocardial infarction. We evalu- ated the effects of eplerenone in patients with chronic systolic heart failure and mild symptoms. METHODS 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 car- diovascular causes or hospitalization for heart failure. RESULTS 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 ra- tio, 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). Hospital- izations 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). CONCLUSIONS 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; number, NCT00232180.)

Subjects by Vocabulary

Medical Subject Headings: food and beverages fungi

Microsoft Academic Graph classification: Ejection fraction Spironolactone chemistry.chemical_compound chemistry Cardiology medicine.medical_specialty medicine Eplerenone medicine.drug Heart failure medicine.disease Myocardial infarction Placebo Internal medicine business.industry business Finerenone Hazard ratio


Aged, Cardiovascular Agents, Cardiovascular Diseases, Combined Modality Therapy, Defibrillators, Implantable, Double-Blind Method, Eplerenone, Female, Follow-Up Studies, Heart Failure, Hospitalization, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Mineralocorticoid Receptor Antagonists, Proportional Hazards Models, Spironolactone, PURLs®, LEFT-VENTRICULAR DYSFUNCTION, ACUTE MYOCARDIAL-INFARCTION, MINERALOCORTICOID RECEPTOR, CARDIAC FIBROSIS, TASK-FORCE, ALDOSTERONE, ASSOCIATION, SURVIVAL, TRIAL, General Medicine

Related to Research communities