Heart Failure Drug May Raise Death Risk
TUESDAY, April 19, 2005 (HealthDay News) -- A team of physician-researchers has heightened its warning about a drug given to 10 percent of the 1 million Americans hospitalized each year with congestive heart failure.
A report issued last month said the drug nesiritide (Natrecor) increased risks for major kidney problems in those patients.
And in this new study, "we show that it is associated with an increased risk of death in acute heart failure," said Dr. Keith Aaronson, an associate professor of cardiovascular medicine at the University of Michigan, and co-author of a report in the April 20 issue of the Journal of the American Medical Association. Aaronson was also an investigator on the first report.
A review of data from three separate trials found the chance of dying in the month after treatment was 80 percent higher for the 485 patients given nesiritide than the 377 given other drugs, the latest report found.
That finding is admittedly not the last word on the drug, said Dr. Jonathan Sackner- Bernstein, director of clinical research at the Heart Failure and Cardiomyopathy Center of North Shore Hospital in Manhasset, N.Y. He is also a co-author on both reports. But it does show that a controlled trial of nesiritide is urgently needed, he added.
"This is a meta-analysis [review], which can't be used as proof of harm or proof of benefit," Sackner-Bernstein said. "The way that people should look at the data is not that nesiritide should never be used. But it should be used only as a drug of last resort until a study is done showing that it is safe."
Heart failure, a progressive decline of the heart's ability to pump blood, affects an estimated 5 million Americans, with more than 500,000 new cases diagnosed each year. Symptoms include shortness of breath, especially when exercising, fluid retention and a swelling of the feet and ankles.
The usual first-line therapy is diuretics, drugs that flush water from the body, with nitroglycerine used as an alternative. Nesiritide is given to strengthen heart function.
"It is given to make people feel better and lower pressure in the heart," Sackner-Bernstein said. "But the drug has not been studied to show what its long-term safety is."
Nesiritide is often used as first-line therapy, but "we certainly feel strongly that physicians should only use this drug when standard treatments have failed," Aaronson said.
The drug gained approval from the U.S. Food and Drug Administration on the basis of studies indicating that it might be helpful for some patients, Sackner-Bernstein said.
Better treatments for patients hospitalized with congestive heart failure certainly are needed, since the mortality rate is high, Aaronson said. "But at this point, nesiritide does not appear to be a better treatment," he said. "The burden of proof is on the maker of the drug to show that the drug is safe and effective."
A statement by Mark Wolfe, director of publicity for Johnson & Johnson, parent company of Scios Inc., which markets Natrecor, said, "Natrecor is highly effective for patients with acutely decompensated heart failure, a life-threatening condition for which there are limited treatment options. We take any question about the safety of Natrecor seriously. At the same time, a review of Scios' full data set does not show a statistically significant difference in mortality. With patient safety as our top priority, an external review of our existing data and a full clinical development program is underway."
The review is being conducted by a panel headed by Dr. Eugene Braunwald. Wolfe said that any decision on a controlled trial would depend on the recommendations made by that panel.
There has been talk of a controlled trial in Europe, Sackner-Bernstein said, "but such talk has been going on since 2003. Hopefully, the study will be done, and in that case I will applaud it."
More information
The American Heart Association provides a detailed explanation of heart failure.
