Phase III study of LCZ 696 meets endpoint for Heart Failure - Novartis
Novartis has presented outline data revealing a reduction in cardiovascular (CV) deaths with LCZ 696 in patients with Heart Failure with reduced ejection fraction (HF-REF). The 8,442 patient Phase III study, PARADIGM-HF, was specifically designed to see if LCZ 696 could increase survival over and above what can be achieved with ACE-inhibitor enalapril in addition to current best treatment in HF-REF patients.
The study met the primary endpoint showing LCZ 696 reduced heart failure hospitalizations along with CV deaths. The primary outcome is a composite of time to first occurrence of either cardiovascular death or heart failure hospitalization, and is the largest heart failure study ever done. Detailed data will be presented in 7 papers at the European Society of Cardiology Congress 2014.