In 2010, the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF) study revealed the drug's benefit in a broader population, i.e., patients with chronic systolic heart failure and mild symptoms. There was a 24% reduction in cardiovascular death and a 42% reduction in hospitalization for heart failure in patients who took the drug compared to those who did not.
"These results where overwhelming," Dr. Pitt said, noting that the benefits were so clear that the trials were stopped early in countries where the drug was already on the market.
The study continued for another 10 months in countries where eplerenone was not available, thus providing additional data that Dr. Pitt said reinforces the earlier findings. Furthermore, a new sub-analysis of the study showed reductions in death and hospitalization in five different groups of high-risk patients with chronic heart failure and mild symptoms, including patients older than age 75 and patients who have diabetes. Although there was an increase in the incidence of hyperkalemia among patients in the high-risk groups who took eplerenone, there was no increase in serious hyperkalemia or hyperkalemia that warranted hospitalization. Dr. Pitt will discuss the most recent data and the new sub-analysis at the meeting.
An older study, the Randomized Aldactone Evaluation Study (RALES) published in 1999, showed a benefit in people with severe heart failure and reduced left ventricular ejection fraction who took the aldosterone antagonist spironolactone. (Ejection fraction is the fraction of blood pumped out of a ventricle with each heartbeat.) "Together, these three studiesEPHESUS, EMPHASIS-HF and RALESprovide the basis for why we think aldosterone antagonists are so important," Dr. Pitt said.
Finally, Dr. Pit
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American Physiological Society