The EMphasis-HF study evaluated the efficacy of eplerenone in 2737 patients with NYHA class 2 heart failure, reporting a significant 37% reduction in the composite primary outcome of cardiovascular death and hospitalization for heart failure after a median follow-up of 21 months. Eplerenone also showed a 24% reduction in cardiovascular death and a 42% reduction in hospitalizations for heart failure, with hyperkalemia being the main side effect. Experts expressed excitement for the drug's potential in treating mild heart failure, tempered by concerns about monitoring and side effects.

1. EMPHASIS-HF

2. EMPHASIS-HF
F Zannad (INSERM, Nancy University, France)
American Heart Association 2010 Scientific Sessions
• Background:
Aldosterone blockade—with spironolactone or the newer more selective
eplerenone—has already shown benefits in class 3-4 HF and in post-MI
patients with HF
This study examined eplerenone in patients with mild HF
• Population and treatment:
2737 patients with NYHA class 2 HF and an ejection fraction ≤35%
Randomized to eplerenone (up to 50 mg daily) or placebo in addition to
recommended therapy
• Primary outcome:
The composite of death from CV causes or hospitalization for HF

3. EMPHASIS-HF: Results (efficacy)
• After a median follow-up of 21 months, the trial was stopped early because of a
significant benefit in the eplerenone group
• There was a 37% reduction in the primary end point, a 24% reduction in CV death,
and a 42% reduction in hospitalization for HF
• The main side effect was hyperkalemia, with potassium levels >5.5 mmol/L; 11.8%
with eplerenone vs 7.2% with placebo (p<0.001)
Major results
Outcome Eplerenone Placebo Adjusted hazard ratio p
(n=1364), % (n=1373), % (95% CI)
Primary end point 18.3 25.9 0.63 (0.54–0.74) <0.001
CV death 10.8 13.5 0.76 (0.61–0.94) 0.01
HF hospitalization 12.0 18.4 0.58 (0.47–0.70) <0.001
Hospitalization for hyperkalemia 0.3 0.2 1.15 (0.25–5.31) 0.85

4. EMPHASIS-HF: Commentary*
"We were overwhelmed by the results. We expected them to be good, but we were
surprised by how good they were."
- Dr Bertram Pitt (co–principal investigator)
"I am enthusiastic about expansion of the population for these drugs to include
patients with mild heart failure, but my enthusiasm is tempered by the hyperkalemia
issue."
- Dr Clyde Yancy
"You can't just put a patient on this drug and say see you in two months. It requires
close monitoring that will increase the workload . . . but I would still say it is worth
the effort."
- Dr Mariel Jessup
*All comments from EMPHASIS-HF: Eplerenone shows large benefits in milder heart failure
(http://www.theheart.org/article/1147165.do)

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