MUSC part of new treatment discovery for heart failure patients
September 4, 2014
New heart failure medicine touted as best advance in more than a decade
CHARLESTON, SC – Medical University of South Carolina (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., MUSC 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 MUSC cardiologist Terry O’Brien.
“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.
Given the significant results of the PARADIGM trial, NOVARTIS is opening a second five-year study of the same drug in patients with heart failure with preserved ejection fraction (HF-PEF). According to Zile, more than half of these patients will not survive beyond five years, and 50 percent of those hospitalized are likely to be readmitted within six months. Like HF-REF, patients with HF-PEF endure a difficult quality of life and the reduced ability to participate in everyday activities.
“HF-PEF is very common, very lethal, and it causes an unbelievable burden on our patients. To date, zero clinical trials have demonstrated that you can improve morbidity and mortality for them,” Zile said. For the second trial involving this new investigational medicine, called the PARAGON-HF trial, Zile and MUSC are again poised to break new ground, and will be enrolling participants soon. For more information or to learn about enrollment in the PARAGON trial, call 843-792-3738.
To view multimedia information associated with this release from NOVARTIS, click http://www.multivu.com/
About MUSC
Founded in 1824 in Charleston, The Medical University of South Carolina is the oldest medical school in the South. Today, MUSC continues the tradition of excellence in education, research, and patient care. MUSC educates and trains more than 3,000 students and residents, and has nearly 13,000 employees, including approximately 1,500 faculty members. As the largest non-federal employer in Charleston, the university and its affiliates have collective annual budgets in excess of $1.7 billion. MUSC operates a 750-bed medical center, which includes a nationally recognized Children’s Hospital, the Ashley River Tower (cardiovascular, digestive disease, and surgical oncology), Hollings Cancer Center (one of 68 National Cancer Institute designated centers) Level I Trauma Center and Institute of Psychiatry. For more information on academic information or clinical services, visit www.musc.edu. For more information on hospital patient services, visit www.muschealth.com.
