J&J heart drug linked to increased death risk

The analysis, from researchers at North Shore University Hospital in New York and the University of Michigan Cardiovascular Center, estimates that patients treated with the intravenous drug nesiritide (Natrecor) were 80% 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’s authors 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,” said Dr Jonathan Sackner-Bernstein, the study’s principal investigator and director of clinical research at the Heart Failure and Cardiomyopathy Center at North Shore University Hospital.

Now, however, Sackner-Bernstein adds, “This new meta-analysis estimating the risk of death to be increased by 80% 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.”

The study authors have acknowledged that their study cannot give definitive proof of harm, but note that these are the only data that evaluate the safety of nesiritide in randomized, double-blind controlled trials, hence the call for a safety trial to be performed.

The findings thus far have led co-investigator Dr Keith Aaronson, associate professor of cardiovascular medicine at the U-M Medical School and medical director of the U-M heart transplant program, to state that he believes the first choice for treatment should be diuretics, which he says are effective and cost much less than nesiritide.

On April 12 Scios released a statement to say that the company will convene an expert panel to evaluate the risks of nesiritide.