In a head-to-head comparison, an experimental drug was more effective than standard treatment at preventing deaths and hospitalizations in heart failure patients.
According to the study authors, the trial was stopped early because of the marked benefit of the new drug, dubbed LCZ696.
In the trial, 26.5 percent of those getting the standard medication, enalapril (Vasotec), either died or were hospitalized due to heart failure, compared with 21.8 percent of those on the new drug. Enalapril belongs to a class of blood pressure-lowering medications known as ACE inhibitors.
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"LCZ696 could become the new gold standard, replacing ACE inhibitors," said lead researcher John McMurray, M.D., a professor of cardiology at the British Heart Foundation Cardiovascular Research Center at the University of Glasgow, in Scotland.
LCZ696 combines two blood pressure drugs -- an angiotensin II receptor blocker (ARB) and the neprilysin inhibitor known as sacubitril.
"We found that LCZ696 was superior to the gold-standard ACE inhibitor for heart failure -- an ACE inhibitor being the absolute cornerstone of treatment for this problem," he said.
Not only did LCZ696 beat enalapril, but it did that even when added to other treatments, Dr. McMurray noted.
"The new treatment was very well tolerated, with no significant safety concerns," he added.
The report was published online Aug. 30 in the New England Journal of Medicine, to coincide with a presentation at the European Society of Cardiology annual meeting in Barcelona. The trial was funded by Novartis, the maker of LCZ696.
Mariell Jessup, M.D., a professor of medicine at the University of Pennsylvania's Perelman School of Medicine, said, "There is new hope for heart failure."
She added, "We have not had a new drug for heart failure for many years. LCZ696 is a unique compound that may represent a new approach."
Doctors have relied on ACE inhibitors for over two decades, she said. According to Jessup, who wrote an accompanying editorial, "Newer drugs that work via alternate pathways may [show] benefit beyond the medical therapy that is used today."
For the study, over 8,400 patients with heart failure were randomly chosen to receive LCZ696 or enalapril.
Over an average of 27 months of follow-up, LCZ696 reduced the risk of hospitalization for heart failure by 21 percent, compared to enalapril, the findings showed.
Moreover, among the 1,251 people who died from heart disease during the trial, 558 were taking LCZ696 (13.3 percent) and 693 were taking enalapril (16.5 percent), the researchers noted.
Gregg Fonarow, M.D., a professor of cardiology at the University of California, Los Angeles, commented, "The results of this study are terrific news for patients with heart failure, and represent landmark findings."
If approved by the U.S. Food and Drug Administration, this new medication should help doctors improve outcomes for the millions of men and women with chronic heart failure worldwide, he said.
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