Positive results in study of LCZ 696 for Heart Failure - Novartis

Data from a Phase III trial shows that LCZ 696, from Novartis, 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 LCZ 696 were more likely to be alive and less likely to have been hospitalized for sudden deterioration of their heart failure than those given ACE-inhibitor enalapril. Patients received LCZ696 or enalapril on top of current best treatment. The magnitude of benefit with LCZ 696 against enalapril in HF-REF patients was highly statistically significant and clinically important. In the study, the benefit of LCZ 696 was seen early, was sustained and was consistent across subgroups.

The drug:

• reduced the risk of death from cardiovascular (CV) causes by 20%
• reduced heart failure hospitalizations by 21%
• reduced the risk of all-cause mortality by 16%

Overall there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or heart failure hospitalization. Analysis of the safety data from PARADIGM-HF showed side effects were manageable in the study. Fewer patients on LCZ 696 discontinued study medication for any adverse event compared to those on enalapril (10.7% vs. 12.3%, respectively). The LCZ 696 group had more hypotension and non-serious angioedema but less renal impairment, hyperkalemia and cough than the enalapril group. See: "Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure." McMurray JJV, Packer M, Desai AS, et al. N Engl J Med. 2014. doi: 10.1056/NEJMoa1409077.