Positive interim results cause heart failure drug trial to close earlyNews - Apr. 1, 2014
The Data Monitoring Committee has unanimously recommended early closure of the PARADIGM-HF trial after the combined primary endpoint was met in interim analysis. The PARADIGM-HF trial studied the investigational agent LCZ696 (Novartis) in patients with chronic heart failure with reduced ejection fraction (HF-REF). Patients who received LCZ696 lived longer, without being hospitalised for HF, than those who were randomised to standard care with ACE-inhibitor enalapril. As a consequence of these positive results, the trial will now close early.
LCZ696 has multiple mechanisms of action on the neurohormonal systems of the heart. This first-in-class angiotensin receptor neprilysin inhibitor (ARNI), not only reduces the strain on the heart, but it also promotes the heart muscle to recover.
The PARADIGM-HF trial is a randomised, double-blind, phase III outcome study that evaluated the efficacy and safety of LCZ696 (pill) twice daily against enalapril, in almost 8500 patients with HF-REF. The primary outcome is a composite of time to first occurrence of either CV death or HF hospitalisation. Two previous interim analyses have shown LCZ696 to have an acceptable safety profile.
To date, no satisfactory treatment existed for HF patients, which could extend and improve their lives. Since LCZ696 was found to be superior to currently recommended doses of enalapril, LCZ696 may develop into a new cornerstone in the management of chronic HF.
Novartis announces that the results of the PARADIGM-HF will be submitted for presentation to a major medical conference, and it will approach regulatory bodies about approval.