In a press release last week, Novartis announced that the Data Monitoring Committee unanimously recommended an early closure of the PARADIGM-HF study testing the Angiotensin Receptor Neprilysin Inhibitor (ARNI), LCZ696. This treatment is a pill that taken twice daily for heart failure, and it acts by blocking receptors exerting harmful effects while promoting protective mechanisms. Researchers are optimistic that this new drug could potentially offer an advance over other therapies for heart failure.
Tim Wright, the Global Head of Development for Novartis, released a statement on the closure of the trials. “Novartis recognizes the huge global need for treatments that extend and improve the lives of people with heart failure and we believe LCZ696's unique mechanism of action could be transformative,” said Wright. “This result is a demonstration of our commitment to developing innovative medicines that have an impact on the most important outcomes like cardiovascular mortality.”
The results of the PARADIGM-HF study will now be sent to a major medical conference for presentation, and Novartis will move toward getting marketing approval from various health regulatory bodies. Dr. Milton Packer of the University of Texas Southwestern Medical Center was one of the study's principal investigators. He called the results 'impressive.' “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,” said Packer.
According to Larry Husten of Forbes, the AHA estimates that 5 million people in the U.S. now have heart failure, and this number will continue to increase as the elderly population grows and as more people survive heart attacks. In an interview with Forbes, Clyde Yancy, a leading heart failure expert who was removed from the Novartis trial, said that a treatment that can outperform ACE inhibitor therapy in heart failure. Yancy says, “As good as ACE inhibitors have been in heart failure perhaps there is something that is better, and better is what we need. We won’t be able to fully arbitrate these results until they’re seen, but given the increasing morbidity of heart failure, the increasing cost of care, and the increasing cost to human life, having something better than an ACE inhibitor really does qualify as a breakthrough.”