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Pfizer releases EMPHASIS-HF trial pre-specified sub-analysis results

Pfizer's EMPHASIS-HF trial pre-specified sub-analysis results demonstrated that the addition of Inspra (eplerenone) reduces the incidence of new onset atrial fibrillation or flutter (AF/F) in patients suffering from systolic heart failure and mild symptoms, compared with placebo plus standard therapy.

Inspra (eplerenone) is a steroid nucleus-based mineralcorticoid receptor (MR) antagonist with a higher degree of selectivity than spironolactone.

In the Phase 3B, multinational, randomized, double-blind placebo-controlled, parallel-group trial, the effect of eplerenone on the primary endpoint (CV mortality or hospitalization for heart failure) was similar among patients with or without AF/F at baseline.

The sub-analysis evaluated the subjects without a history of AF/F based on the baseline ECG and physical examination (911 in the eplerenone group and 883 in the placebo group).

The trial recruited around 2,737 patients with chronic systolic heart failure (NYHA class II) and mild symptoms.

Sahlgrenska University Hospital Department of Medicine Karl Swedberg said their findings, which suggest that aldosterone antagonism in heart failure might influence atrial fibrosis and remodeling, and therefore the risk of developing atrial fibrillation/flutter, should provide real encouragement for doctors and patients alike.