A huge clinical trial testing a novel compound from Novartis Novartis for continual heart failure has been stopped early for efficacy. In a press release Novartis mentioned the Data Monitoring Committee had advisable early closure of the PARADIGM-HF trial because the trial had demonstrated a important reduction in the mixed main endpoint of cardiovascular death and heart failure hospitalization.
PARADIGM-HF randomized sufferers with heart failure and lowered left ventricular ejection fraction to both the ACE ACE inhibitor enalapril or LCZ696, an Angiotensin Receptor Neprilysin Inhibitor (ARNI) that is the first in its class. Almost 8,500 sufferers were studied in the trial, which Novartis mentioned produced it the greatest-ever trial in heart failure.
“The outcomes of PARADIGM-HF are genuinely impressive” said heart failure specialist Milton Packer, a Principal Investigator of the trial. “The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling proof that supports LCZ696 as a new cornerstone in the management of persistent heart failure.”
Novartis mentioned the trial findings will be presented at a health care conference in the potential and that the company will seek to obtain approval for the drug with regulators.
The announcement follows by only a couple of days the rejection of a diverse Novartis heart failure compound, serelaxin, by an FDA advisory panel.