Eplerenone verbetert overleving bij patiënten met mild systolisch hartfalen

N Engl J Med 2010; Advance online publication (PDF).

Eplerenone, in addition to recommended therapy, significantly reduces cardiovascular death and hospitalization for heart failure in patients with systolic heart failure and mild symptoms, results from EMPHASIS-HF indicate.

The Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF) included a total of 2737 patients aged ≥55 years with New York Heart Association functional class II symptoms and an ejection fraction of ≤35%.

The patients, who were receiving recommended therapy, were randomly assigned to receive eplerenone, at an initial dose of 25 mg once-daily, which was increased after 4 weeks to 50 mg provided that the patients' serum potassium levels were ≤5.0 mmol/l, or placebo.
 

Baseline characteristics were well matched in the two groups. Patients in the eplerenone group had an average age of 68.7 years versus 68.6 years for placebo-treated patients. The average left ventricular ejection fraction was 26.2% and 26.1%, respectively, and 32.2% and 34.5% of patients, respectively, had an estimated glomerular filtration rate of <60 ml/min/1.73 m².

The primary endpoint of cardiovascular death or hospitalization for heart failure occurred in 18.3% of patients treated with eplerenone and 25.9% of placebo-treated patients, at an adjusted hazard ratio (HR) of 0.63 (p<0.001). The number needed to treat per year of follow-up to prevent one occurrence of the primary endpoint was 19, whereas that needed to prevent one death was 51.
 

Eplerenone treatment also significantly reduced the risk for death from all causes compared with placebo (12.5% versus 15.5%; HR, 0.76; p<0.008), as well as the risk for death from cardiovascular causes (10.8% versus 13.5%; HR 0.76, p<0.01), hospitalization for heart failure (12.0% versus 18.4%; HR, 0.58; p<0.001), and hospitalization for all causes (29.9% versus 35.8%; HR, 0.77; p<0.001).
 

Serum potassium levels increased above 5.5 mmol/l in 11.8% and 7.2% of eplerenone- and placebo-treated patients, respectively (p<0.001). There were no significant differences in the number of patients who discontinued treatment due to an adverse event (p=0.09).
 

"This treatment is certainly going to change the guidelines for mild heart failure," lead investigator Faiez Zannad (Nancy University Hospital Center, France) told delegates at the American Heart Association Scientific Sessions in Chicago, Illinois, USA.
 

"Now patients with all kinds of severity of systolic heart failure, which is post-myocardial infarction, with mild or severe symptoms, are potentially eligible for some kind of aldosterone blockade and, certainly, for eplerenone."