A Phase IIIb trial has confirmed that adding Pfizer’s Inspra™ (eplerenone) to standard therapy for heart failure significantly reduces the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure and mild symptoms. Although the aldosterone antagonist is has previously been approved for two specific indications in the U.S., it has yet to be cleared for the indication evaluated in the reported Emphasis-HF study. Rather, the current FDA sanction includes use of the drug in the treatment of hypertension and for improving the survival of stable patients with left ventricular systolic dysfunction (LVSD) and clinical evidence of congestive heart failure after acute myocardial infarction. The drug is in addition approved in the EU for use in patients with LVSD.
Positive results from the Emphasis-HF trail have been expected, however. The study included 2,737 patients in 29 countries. In May further recruitment was halted early after interim data showed significant enough benefits to meet predefined stopping rules.
Final data from the trial has now confirmed that in comparison with treatment using standard therapy alone, the use of standard therapy plus Inspra reduced the relative risk of the death from cardiovascular causes or heart failure hospitalization by 37%. Secondary endpoints were also met. Among Inspra-treated cohorts, all-cause mortality was down 24%, CV mortality by 24%, and heart failure hospitalization by 42%.