According to the results of a sub-analysis of the EMPHASIS-HF study presented at the European Society of Cardiology Heart Failure Congress, the addition of eplerenone (Inspra®) to standard therapy reduced the incidence of new onset atrial fibrillation or flutter (AF/F) in patients with systolic heart failure and mild symptoms.

The EMPHASIS-HF trial enrolled 2,737 subjects with chronic systolic heart failure (NYHA class II) and mild symptoms. The primary objective was to evaluate the efficacy and safety of eplerenone plus standard heart failure (HF) therapy on the cumulative incidence of cardiovascular (CV) mortality and HF hospitalisation (a composite primary endpoint).  This sub-analysis looked at subjects without a history of AF/F (911 in the eplerenone group and 883 in the placebo group).  In these patients, new onset AF/F occurred in 25 (2.7%) patients in the eplerenone group versus 40 (4.5%) patients in the placebo group (hazard ratio [HR] 0.58; 95% CI 0.35-0.96, p=0.034).  The effect of eplerenone on the primary endpoint (CV mortality or hospitalisation for heart failure) was similar among patients with or without AF/F at baseline (HR 0.60, 95% CI 0.46-0.79 vs. HR 0.70, 95% CI 0.57-0.85, p-value for interaction =0.41).

The main results of the EMPHASIS-HF study were published in the New England Journal of Medicine in November 2011 – please see the NeLM report at the link below for further details.

The article notes that eplerenone is not authorised for use in the patient population studied in the EMPHASIS-HF trial or in patients with atrial fibrillation/flutter in any country.