Doctors raise concern about heart drug Nesiritide

Mar 22 2005

Doctors raise concern about heart drug. The heart drug Nesiritide (Natrecor) is an FDA-approved drug for the treatment of decompensated heart failure, the most common reason for hospitalization for those over 65 years of age. Decompensated heart failure results in nearly one million hospitalizations annually, Nesiritide is used for nearly 10% of heart failure-related hospitalizations.

Now doctors at North Shore University Hospital in New York and the University of Michigan are concerned that nesiritide worsens kidney function when used as a treatment of acutely decompensated heart failure and are concerned about the safety of the drug, because previous 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. Nesiritide is produced by Scios Inc., a unit of Johnson and Johnson.

In a study published in Circulation, the official journal of the American Heart Association, Jonathan Sackner-Bernstein, MD, the study's principal investigator and director of clinical research at the Heart Failure and Cardiomyopathy Centre at North Shore University Hospital in Manhasset, NY, says 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. His data is based on analysis of randomized, controlled trials 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. Keith Aaronson, MD, associate professor in the Division of Cardiovascular Medicine at the University of Michigan, and a co-investigator of the Circulation study says almost all the hospitalizations occurred because patients were short of breath from retaining too much fluid.

Many doctors have embraced nesiritide in the belief that fluid can be removed and symptoms improved more quickly without risk; they are all looking for ways to make heart failure patients feel better and discharged from the hospital as quickly as possible. According to the data, that is not the case. Although it is not understood how Nesiritide leads to worsening kidney function in patients with decompensated heart failure, it is of concern in that it is associated with a higher risk of death.

Dr.Sackner-Bernstein suggests the findings show there is a need for appropriately sized clinical trials to establish the safety of nesiritide in relation to its benefits on symptoms as the long-term safety of nesiritide has not been established. According to the American Heart Association's annual report for 2005, acutely decompensated heart failure is the cause of nearly 1,000,000 hospitalizations annually, with these hospitalizations costing Medicare $3.6 billion in 1999.