Analysis of data from FDA, manufacturer prompts call for new nesiritide study
A drug that helps heart failure patients survive a crisis may actually increase their risk of dying in the first month after they leave the hospital, according to a new study that will be published April 20 in the Journal of the American Medical Association. In fact, the analysis shows, patients treated with the intravenous drug nesiritide were 80 percent more likely to die in the next month than patients who received traditional drugs for acute heart failure symptoms, such as diuretics and vasodilators. The study analyzed clinical trial data obtained from the manufacturer of the drug, which is marketed as Natrecor, and from the U.S. Food & Drug Administration. All the clinical trials were conducted by the manufacturer, Scios, a unit of Johnson & Johnson.
The study’s authors, from North Shore University Hospital in New York and the University of Michigan Cardiovascular Center, also published findings in March showing that nesiritide is associated with a much higher risk of kidney dysfunction.
Kara Gavin | EurekAlert!
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