An experimental drug has shown a striking efficacy in prolonging the lives of people with heart failure and could replace what has been the bedrock treatment for more than 20 years, researchers said Saturday.
The drug, which is being developed by the Swiss company Novartis, reduced both the risk of dying from cardiovascular causes and the risk of being hospitalized for worsening heart failure by about 20 percent in a large clinical trial.
"I think that when physicians see these data, they will find it compelling, and what we will see is a paradigm shift," said Dr. Milton Packer, a professor of clinical sciences at the University of Texas Southwestern Medical Center in Dallas and one of the two principal investigators in the study.
The results were presented at the European Society of Cardiology conference in Barcelona, Spain, on Saturday and were published by the New England Journal of Medicine.
Heart failure is a disease in which the heart cannot pump enough blood to the body's organs, resulting in shortness of breath, fatigue and retention of fluids. Some 5 million to 6 million Americans, and an estimated 26 million people globally, have heart failure, and it is the leading cause of hospitalization in the United States and Europe, according to a recent paper in the Journal of the American College of Cardiology.
Some doctors not involved in the study agreed that the results were compelling.
"They are not just positive, they are remarkably positive and positive in every dimension," said Dr. Clyde Yancy, chief of the cardiology division at the Northwestern University Feinberg School of Medicine. "Patients with heart failure are eager, if not desperate to have better options."
Novartis executives say the company will file for approval of the drug, known by the code name LCZ696, in the United States by the end of the year and in Europe in early 2015. That means the drug could get to patients as early as next year.
The study involved nearly 8,500 people in 47 countries and was the largest experiment ever done in heart failure. Independent monitors stopped the study in April, seven months earlier than planned, when it was clear the drug was better than an older one that is standard now.