Landmark Study Shows Novartis Experimental Drug Far Superior to ACE Inhibitor Enalapril in Reducing Risk of Death Associated with Heart Failure

According to a Novartis press release, on August 30, 2014, at the European Society of Cardiology congress in Barcelona, and published simultaneously in the New England Journal of Medicine, the company revealed that its investigational heart failure medicine, LCZ696, was superior to ACE inhibitor enalapril on key endpoints in the largest heart failure study ever done. In PARADIGM-HF patients with heart failure with reduced ejection fraction (HF-REF) who were given LCZ696 were more likely to be alive and less likely to have been hospitalized for sudden deterioration of their heart failure than those given the ACE inhibitor enalapril. Patients received LCZ696 or enalapril on top of the current best treatment. The magnitude of benefit with LCZ696 against enalapril in HF-REF patients was highly statistically significant and clinically important. In the study, the benefit of LCZ696 was seen early, was sustained, and was consistent across subgroups. LCZ696 reduced the risk of death from cardiovascular (CV) causes by 20% (p=0.00004), reduced heart failure hospitalizations by 21% (p=0.00004), reduced the risk of all-cause mortality by 16% (p=0.0005). Overall, there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or heart failure hospitalization (p=0.0000002). "By demonstrating a very significant reduction in cardiovascular deaths while improving quality of life, Novartis's new heart failure medicine, LCZ696, represents one of the most important cardiology advances of the last decade," said Dr. David Epstein, Division Head, Novartis Pharmaceuticals.
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