Pfizer said that the Emphasis-HF trial demonstrated a 37% relative risk reduction for the eplerenone group compared to placebo in the primary composite endpoint of death from CV causes or HF hospitalisation.
There were also prominent reductions in other secondary endpoints of all-cause mortality (24%), CV mortality (24%), all-cause hospitalisation (23%) and HF hospitalisation (42%).
Emphasis-HF Steering Committee co-chair Faiez Zannad said that it was encouraging to see a clinical trial deliver results that are sufficiently strong to meet strict pre-defined stopping criteria.
Emphasis-HF trial primary objective 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 hospitalisation.
Reportedly, patients enrolled in the study had New York Heart Association (NYHA) Class II chronic systolic heart failure with mild symptoms.
Pfizer stated that 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 in the primary endpoint was evident.