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Adding INSPRA® (eplerenone) to Standard Therapy Significantly Reduces the Risk of CV Mortality and Morbidity in Patients With Chronic Heart Failure With Mild Symptoms, Study Shows
Date:11/14/2010

re provide real encouragement for doctors and patients alike."

The primary objective of the EMPHASIS-HF trial was to evaluate the efficacy and safety of eplerenone plus standard HF therapy versus placebo plus standard HF therapy on the cumulative incidence of the composite endpoint of CV death or HF hospitalization.  Patients enrolled in the study had New York Heart Association (NYHA) Class II chronic systolic heart failure with mild symptoms.  

No new safety information emerged as a result of this study.  As anticipated, there was a higher incidence of hyperkalemia (elevated potassium, defined as serum potassium level >5.5mmol/L.) among patients assigned to eplerenone compared to placebo (11.8% vs 7.2%, respectively; p<0.001).  In contrast, the incidence of hypokalemia (low potassium, defined as serum potassium level <3.5mmol/L.) was lower in the eplerenone group compared to placebo (7.5% vs 11.0%, respectively; p=0.002).  

In May 2010, recruitment to the EMPHASIS-HF trial was halted early after the second pre-specified interim analysis showed that the study's pre-defined stopping rules had been met and a significant difference (two-sided P<0.001 in favor of eplerenone) in the primary endpoint was evident.

Eplerenone is not authorised for use in the patient population studied in the EMPHASIS-HF trial in any individual market.

About the EMPHASIS-HF trial

EMPHASIS HF (A6141079) is a phase 3B, multinational (2,737 patients from 272 centres in 29 countries), randomized, double-blind placebo-controlled, parallel-group trial.  It is conducted in a NYHA II chronic systolic heart failure population, which is a distinct population from the EPHESUS study population (patients with left ventricular dysfunction (LVEF less than or equal to 40 %) and clinical evidence of heart failure after recent myocardial infarction).  In Europe, the current approved indication for eplerenone is b
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SOURCE Pfizer Inc.
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