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.

"When we reported that nesiritide is linked to worsening kidney function, some physicians did not seem convinced that concern was warranted," says Jonathan Sackner-Bernstein, M.D., the study's principal investigator and director of clinical research at the Heart Failure and Cardiomyopathy Center at North Shore University Hospital in Manhasset, NY. He notes that a Scios spokesperson was quoted in the press saying that the kidney effect was already "well-known" and "dose related", and "not associated with worse outcomes."

But, Sackner-Bernstein adds, "This new meta-analysis estimating the risk of death to be increased by 80 percent serves as a compelling argument for a randomized, controlled clinical trial to be performed, to define the risks associated with nesiritide prior to its widespread use. To date, the company has not initiated any trial that will address these concerns about the link between nesiritide therapy a
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Contact: Kara Gavin or Sally Pobojewski
kegavin@umich.edu
734-764-2220
University of Michigan Health System
19-Apr-2005