http://www.theheart.org/web_slides/1297743.do Follow-up of high-risk subgroups from the EMPHASIS-HF trial, which examined aldosterone blockade with eplerenone in patients with mild HF

1. EMPHASIS-HF (follow-up of high-risk
subgroups)

2. EMPHASIS-HF (follow-up of high-risk subgroups)
B Pitt (University of Michigan School of Medicine, Ann Arbor)
European Society of Cardiology 2011 Congress
• Follow-up of high-risk subgroups from the EMPHASIS-HF trial, which examined
aldosterone blockade with 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
Results of primary analysis: After a median follow-up of 21 months, the trial
was stopped early because of a significant benefit in the eplerenone group
(primary and secondary outcomes)
HF=heart failure

3. EMPHASIS-HF: Results
• Eplerenone significantly improved the primary end point in high-risk patients
including those with diabetes or renal compromise
Rate of primary end point (HR, 95% CI eplerenone vs placebo) for all subjects
and by high-risk subgroup in EMPHASIS-HF, prespecified analysis
Population Eplerenone Placebo HR (95% CI) p
All subjects 18.3 25.9 0.63 (0.54–0.74) <0.001
Age ≥75 y 23.6 32.7 0.66 (0.49–0.88) 0.004
Diabetes 21.6 35.2 0.54 (0.42–0.70) <0.001
eGFR <60mL/min/1.73m2 24.4 34.5 0.62 (0.49–0.79) 0.001
LVEF <30% 19.3 27.3 0.65 (0.53–0.78) <0.001
SBP <123 mm Hg (trial median) 20.6 29.4 0.63 (0.51–0.79) <0.001
eGFR=estimated glomerular filtration rate; LVEF=left ventricular ejection fraction; SBP=systolic blood
pressure

4. EMPHASIS-HF: Commentary*
"So, overwhelmingly the data are positive . . . to us, the data are pretty
straightforward and pretty compelling for the use of eplerenone in patients with
NYHA class 2 heart failure."
- Dr Bertram Pitt
"For patients with mild heart failure, hospitalization really matters—really matters for
survival, for the progression of the disease, and for quality of life."
- Dr Piotr Ponikowski
*All comments from Eplerenone gains in mild HF cut across high-risk subgroups: EMPHASIS-HF
(http://www.theheart.org/article/1270227.do)

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