EMPHASIS-HF
Trial question
What is the role of eplerenone in patients with chronic systolic HF and mild symptoms?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
22.0% female
78.0% male
N = 2737
2737 patients (610 female, 2127 male).
Inclusion criteria: patients with NYHA class II HF and an ejection fraction of no more than 35%.
Key exclusion criteria: acute MI, NYHA class III or IV HF, serum potassium level > 5.0 mmol/L, an eGFR < 30 mL/min/1.73 m² of body-surface area, or need for a potassium-sparing diuretic.
Interventions
N=1364 eplerenone (up to 50 mg daily plus recommended therapy).
N=1373 placebo (matching placebo plus recommended therapy).
Primary outcome
CV death or hospitalization for heart failure
18.3%
25.9%
25.9 %
19.4 %
12.9 %
6.5 %
0.0 %
Eplerenone
Placebo
Significant
decrease ▼
NNT = 13
Significant decrease in CV death or hospitalization for HF (18.3% vs. 25.9%; HR 0.63, 95% CI 0.54 to 0.74).
Secondary outcomes
Significant decrease in death from any cause (12.5% vs. 15.5%; HR 0.76, 95% CI 0.62 to 0.93).
Significant decrease in death due to cardiovascular causes (10.8% vs. 13.5%; HR 0.76, 95% CI 0.61 to 0.94).
Significant decrease in hospitalizations for HF (12% vs. 18.4%; HR 0.58, 95% CI 0.47 to 0.7).
Safety outcomes
Significant differences in adverse event leading to discontinuation of study drug (13.8% vs. 16.2%, p = 0.09) and hyperkalemia > 5.5 mmol/L (11.8% vs. 7.2%,p < 0.001).
Conclusion
In patients with NYHA class II HF and an ejection fraction of no more than 35%, eplerenone was superior to placebo with respect to CV death or hospitalization for HF.
Reference
Zannad F, McMurray JJ, Krum H et al. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11-21.
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