A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines

In an earlier study, eplerenone was shown to improve survival in patients who had heart
failure immediately following a heart attack. However, it is not known how patients with
established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of
sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus
standard heart failure medicines is being compared to placebo plus standard heart failure
medicines in terms of an additional ability to prolong life and prevent re-hospitalizations
for worsening heart failure in these patients.

The Data Safety Monitoring Committee (DSMC) observed during its conduct of the
protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of
eplerenone had met the pre-specified stopping rules in the protocol. As a result of the
discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended
that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration
that it would be unethical not to offer this treatment to patients, the ESC recommended that
all the patients in the trial should be transferred to open-label eplerenone. The Open Label
Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for
the indication studied in this patient population.

On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered
to be the most appropriate way to ensure that all the subjects who participated in the
double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone