An experimental drug showed great promise in prolonging the lives of people with heart failure and could become the standard of care for millions of people with the condition, 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 the largest clinical trial ever done involving chronic heart failure.
Researchers released the results of the study at the European Society of Cardiology congress in Barcelona, Spain this weekend. The study results were published Saturday by The New England Journal of Medicine.
“We’ve been waiting for over a decade for a new drug on heart failure,” said Dr. Mariell Jessup, a former American Heart Association president and a professor of medicine at the University of Pennsylvania.
The drug “may well represent a new threshold of hope” for patients, she wrote in a commentary in the journal. It may help “a wide spectrum of patients, even those who are currently receiving the best possible therapy.”
“This is a new day” for patients, agreed Dr. Clyde Yancy, cardiology chief at Northwestern University in Chicago and a former American Heart Association president. Dr. Yancy was not involved in the study.
Novartis had announced in March that the PARADIGM-HF trial was ending early because the drug, called LCZ696, had performed so much better than the more commonly used enalapril, an ACE inhibitor sold as Vasotec.
But until Saturday when the study’s results were released, it was not known exactly how much better.
The study involved nearly 8,500 people in 47 countries and was paid for, designed and partly run by Novartis. Independent monitors stopped the study seven months earlier than planned when it was clear the drug was better than an older one that is standard now.
During the 27-month study, the Novartis drug cut the chances of dying of heart-related causes by 20 percent and for any reason by 16 percent, compared to the older drug. It also reduced the risk of being hospitalized for heart failure by 21 percent.
“We are really excited,” said one study leader, Dr. Milton Packer of UT Southwestern Medical Center in Dallas. The benefit “exceeded our original expectations.”
Heart failure is the top reason older people are hospitalized, and a leading cause of death. It develops when the heart muscle weakens over time and can no longer pump effectively, often because of damage from a heart attack. Fluid can back up into the lungs and leave people gasping for breath.
Some six million Americans, and an estimated 24 million people globally, have heart failure, and it is the leading cause of hospitalization in the United States and Europe. Many patients die within a few years of diagnosis.
In the study, 26.5 percent on the older drug, enalapril, died of heart-related causes or were hospitalized for heart failure versus less than 22 percent of those on the Novartis drug. Quality of life also was better with the experimental drug.
“We now have a way of stabilizing and managing their disease which is better than what we could offer them before,” Packer said.
It’s uncertain exactly when the drug will reach market, but it may be as early as next year.
Novartis executives say the company will file for approval of the drug in the United States by the end of the year and in Europe in the first quarter of 2015.
The new drug is a twice-a-day pill combination of two medicines that block the effects of substances that harm the heart while also preserving ones that help protect it. One of the medicines also dilates blood vessels and allows the heart to pump more effectively.
The new drug seemed reassuring because safety concerns doomed a couple of other promising-looking treatments over the last decade. There were more cases of too-low blood pressure and non-serious swelling beneath the skin with the Novartis drug, but more kidney problems, excess potassium in the blood and cough with the older drug. More people on the older treatment dropped out of the study than those on the new one.
About 32 people would need to be treated with the new drug to prevent one death from heart-related causes.
“That’s a favorable number,” said Dr. Joseph G. Rogers, a Duke University cardiologist with no role in the study. He said the benefits were big enough that “I would switch people over” as soon as the drug is available.
The Associated Press contributed to this report.
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