PARADIGM-HF Study Halted Early For Large Benefit
The Data Monitoring Committee (DMC) has unanimously recommended early closure of the PARADIGM-HF study, indicating patients with chronic heart failure with reduced ejection fraction (HF-REF) who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril, according to a statement from Novartis.
Initiated in December 2009, PARADIGM-HF is a randomized, double-blind, Phase III outcome study evaluating the efficacy and safety profile of LCZ696 versus enalapril in 8,436 patients with HF-REF. The primary outcome is a composite of time to first occurrence of either cardiovascular death or heart failure hospitalization. In addition, the trial is designed to be able to detect a significant difference in cardiovascular death.
According to Novartis, the results of the study will now be submitted to a major medical conference for presentation and the company will initiate discussions with global health authorities regarding approval for marketing.
"The results of PARADIGM-HF are truly impressive" said Milton Packer, MD, FACC, professor and chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center, and one of the two Principal Investigators. "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 evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure."
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