'Nearly all of these hospitalizations occur because patients are short of breath from retaining too much fluid. Many physicians have embraced nesiritide in the belief that fluid can be removed and symptoms improved more quickly without risk. According to the data, that just isn't so.'

Since several earlier studies have shown that patients whose kidney function worsens during treatment for decompensated heart failure are at higher risk of dying in the subsequent weeks and months, the latest research spikes concerns about the safety of the drug.

Nesiritide is produced by Scios Inc., a unit of Johnson and Johnson.

Common Reason for Hospitalization

Decompensated heart failure is the most common reason for hospitalization among people over age 65, resulting in nearly one million hospitalizations annually.

"Nesiritide was associated with a 40 to 50 percent higher risk of worsening kidney function when used for the treatment of acutely decompensated heart failure," reports Jonathan Sackner-Bernstein, MD, the study's principal investigator. Dr. Sackner-Bernstein is director of clinical research at the Heart Failure and Cardiomyopathy Center at North Shore University Hospital in Manhasset, New York.

"This data is based on analysis of the randomized, controlled trials conducted by Scios, which studied the effects of Nesiritide in over 1,200 patients. Whether using low or high doses, Nesiritide was associated with significant risk of kidney dysfunction," he notes.

Higher Risk of Death

"We're all looking for ways to get our heart-failure patients feeling better and discharged from the hospital as quickly as possible," says Keith Aaronson, MD, associate professor in the Division of Cardiovascular Medicine at the University of Michigan and a co-investigator of the Circulation study.

"Nearly all of these hospitalizations occur because patients are short of breath from retaining too much fluid. Many physicians have embraced nesiritide in the belief that fluid can be removed and symptoms improved more quickly without risk. According to the data, that just isn't so," Dr. Aaronson points out.

"As of yet, we do not understand how Nesiritide leads to worsening kidney function in patients with decompensated heart failure," observes Dr. Sackner-Bernstein.

"But we do know that worsening kidney function is troubling, in that it generally is associated with a higher risk of death. Together, these observations suggest the need for appropriately sized clinical trials to establish the safety of nesiritide relative to its benefits on symptoms," he concludes.