PARADIGM-HF stopped early after primary endpoint met
Novartis has announced the early closure of PARADIGM-HF, a trial designed to assess the use of a first-in-class treatment for chronic HF in patients with reduced ejection fraction. The trial was stopped after it met the primary composite endpoint, CV-related death or first-incidence of HF-related hospitalization, with strong evidence of efficacy, according to a press release.
Discontinuation of the trial follows the unanimous recommendation of the data monitoring committee and prior interim analyses indicating a favorable safety profile for LCZ696.
The randomized, double blind, phase 3 study was initiated in December 2009. Researchers enrolled more than 8,400 patients, making it the largest HF clinical trial ever undertaken, according to the release. Patients were assigned the angiotensin receptor neprilysin inhibitor LCZ696 or the ACE inhibitor enalapril.
Patients assigned LCZ696 also had longer hospitalization-free survival compared with patients assigned enalapril, according to the release.
“The results of PARADIGM-HF are truly impressive,” Milton Packer, MD, professor and chair of the department of clinical services at University of Texas Southwestern Medical Center, stated in the release. “The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic HF. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic HF.”
Results from PARADIGM-HF will be submitted for presentation at a future medical conference, and Novartis will begin seeking approval for marketing from health authorities worldwide, according to the release.