MUSC part of new treatment for heart failure patientsTweet
MUSC researchers played a vital role in the landmark Paradigm-HF clinical trial, recently published in the New England Journal of Medicine, which revealed Novartis’ investigational heart failure medicine (LCZ696) was superior to ACE-inhibitor enalapril in the largest heart failure study ever done. photo by Anne Thompson, Digital Imaging
MUSC researchers played a vital role in the landmark Paradigm-HF clinical trial, recently announced at the European Society of Cardiology congress in Barcelona, Spain (published simultaneously in the New England Journal of Medicine), which revealed Novartis’ investigational heart failure medicine (LCZ696) was superior to ACE-inhibitor enalapril in the largest heart failure study ever done.
Michael Zile, M.D., professor and Charles Ezra Daniel endowed chair for cardiology, was part of the international steering committee and helped design, implement and evaluate the study alongside numerous center principal investigators, such as cardiologist Terry O’Brien, M.D.
“I have been a cardiologist for 30 years, and this is the most important pharmaceutical clinical trial that I’ve ever been associated with or fortunate enough to participate in,” Zile said. “This will change the fundamental guidelines for therapy in heart failure patients. This medication substantially improves survival and quality of life, and proves that the care we provide is not only state-of-the-art, but also pushes the known boundaries of discovery, ultimately resulting in new, more effective ways to treat our patients.”
This new heart medication cut cardiovascular deaths by 20 percent for patients with heart failure with reduced ejection fractions (HF-REF) versus ACE-inhibitor in the landmark Paradigm-HF trial. Patients who were given LCZ696 were more likely to be alive and less likely to have been hospitalized for sudden deterioration of their heart failure than those given ACE-inhibitor enalapril. Patients received LCZ696 or enalapril in addition to the current standard of care. More than 5 million people suffer from heart failure in the United States, facing a high risk of death and poor quality of life despite currently available medicines.
In the study, the benefit of LCZ696 was seen early, resulting in an early closure of the study from the National Institutes of Health. LCZ696 reduced the risk of death from cardiovascular causes by 20 percent; reduced heart failure hospitalizations by 21 percent; and reduced the risk of all-cause mortality by 16 percent.
LCZ696 reduces the strain on the failing heart by enhancing protective systems of the heart while simultaneously suppressing the harmful effects of overactive systems in these patients’ hearts. Despite existing therapies, the mortality rate remains very high with up to 50 percent of patients dying within five years of a diagnosis of heart failure.
Approximately half of patients with heart failure have HF-REF. Analysis of the safety data from Paradigm-HF showed side effects were manageable in the study and included elevated serum potassium levels, symptomatic hypotension and cough.
Novartis plans to file a new drug application with the FDA by the end of 2014.
To view Novartis multi-media information, visit http://tinyurl.com/kw9a5o6.
September 12, 2014