8/11/2014 6:24:14 AM
Novartis AG To Tout Heart Failure Data At European Society of Cardiology Congress 2014
August 11, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Novartis AG (NVS) will present very promising data at the European Society of Cardiology (ESC) Congress 2014 on its investigation heart failure medication LCZ696. LCZ696 is described as a twice-a-day tablet for heart failure that “acts in a unique multimodal way to enhance the protective neurohormonal system of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).” It is an Angiotensin Receptor Neprilysin Inhibitor (ARNI).
At the Congress, on Sunday August 31st, Novartis will present 7 abstracts (2 oral presentations and 5 posters) describing the research to-date on LCZ696. The medication was part of the PARADIGM-HF study which evaluated the efficacy of LCZ696 compared to enalapril. It was a randomized, double-blind, Phase III outcome study. Enalapril (marketed as Vasotec in the U.S. and Enaladex in some other countries, and Enacard for veterinary use) is an angiotensin-converting-enzyme (ACE) inhibitor used to treat hypertension, diabetic nephropathy, and some types of chronic heart failure.
In March 2014, the PARADIGM-HF trial was ended early because of significant positive results. The Data Monitoring Committee (DMC) unanimously recommended early closure because patients who received LCZ696 lived longer without hospitalization for heart failure than those who received enalapril. In a press release, Dr. Milton Packer, Professor and Chair of the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, USA, one of two Principal Investigators, said, “The results of PARADIGM-HF are truly impressive. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure.”
The PARADIGM-HF study evaluated 8,436 patients with heart failure. In Europe and the U.S., more than 20 million individuals live with the disease, which is associated with high morbidity and mortality, frequent hospitalization and poor quality of life. The ESC presentations will include safety data from the studies indicating the effectiveness of the drug and manageability of the side effects.
Read more recent phase III news.
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