"Eplerenone in Patients with Left Ventricular Dysfunction after Myocardial Infarction".The New England Journal of Medicine. 2003. 348(14):1309-1321.PubMed•Full text•PDF
Contents
1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcomes
8.2 Secondary Outcomes
9 Funding
10 Further Reading
Clinical Question
Among patients with heart failure and left ventricular dysfunction post-acute myocardial infarction, does eplerenone improve survival and decrease morbidity?
Bottom Line
Among patients with heart failure and left ventricular dysfunction post-acute myocardial infarction, eplerenone in addition to optimal medical therapy was found to decrease mortality and morbidity.
Major Points
Guidelines
Modern guidelines reflect the results of this trial and include aldosterone antagonists like eplerenone as part of the therapy for patients with systolic heart failure, particularly after acute myocardial infarction with left ventricular dysfunction.
Design
- Multicenter, international, double-blind, placebo-controlled trial
- N=6,642 patients with recent myocardial infarction and left ventricular dysfunction
- Interventions:
- Eplerenone (25 mg per day, titrated to 50 mg per day; n=3,313)
- Placebo (n=3,319)
- Setting: 674 centers in 37 countries
- Enrollment: December 27, 1999, to December 31, 2001
- Mean follow-up: 16 months
- Analysis: Intention-to-treat
- Primary outcomes: Time to all-cause mortality and time to cardiovascular death or first hospitalization for cardiovascular events
Population
- Inclusion criteria: Documented acute myocardial infarction, left ventricular dysfunction (ejection fraction ≤40%), and heart failure symptoms (or diabetes without heart failure symptoms)
- Exclusion criteria: Use of potassium-sparing diuretics, serum creatinine >2.5 mg/dL, serum potassium >5.0 mmol/L
- Baseline characteristics: Majority of patients were on ACE inhibitors or ARBs, beta-blockers, aspirin, and diuretics
Interventions
Patients randomly assigned to eplerenone or matching placebo in addition to standard therapy for post-myocardial infarction.
Outcomes
Primary Outcomes
- All-cause mortality: 14.4% in the eplerenone group vs. 16.7% in the placebo group (RR 0.85; P=0.008)
- Cardiovascular death or hospitalization: 26.7% in the eplerenone group vs. 30.0% in the placebo group (RR 0.87; P=0.002)
Secondary Outcomes
- Cardiovascular mortality: 12.3% in the eplerenone group vs. 14.6% in the placebo group (RR 0.83; P=0.005)
- All-cause mortality or hospitalization: reduced in the eplerenone group (RR 0.92; P=0.02)
Funding
Supported by a grant from Pharmacia.
Further Reading
For further detailed information, references and links can be found at the PubMed index_gpt and the full article text can be accessed from the New England Journal of Medicine.