MANHASSET, N.Y., March 21 /PRNewswire/ -- Doctors at North Shore University Hospital in New York and the University of Michigan report that nesiritide worsens kidney function when used as a treatment of acutely decompensated heart failure. This publication in Circulation, the official journal of the American Heart Association, raises concern about the safety of nesiritide, since several prior 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.
Decompensated heart failure results in nearly one million hospitalizations annually, the most common reason for hospitalization among people over age 65.
“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,” reported Jonathan Sackner-Bernstein, MD, 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. “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.”
“We’re all looking for ways to get our heart failure patients feeling better and discharged from the hospital as quickly as possible,” said 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.”
“As of yet, we do not understand how Nesiritide leads to worsening kidney function in patients with decompensated heart failure. 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,” said Dr. Sackner-Bernstein.
About Nesiritide
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. Nesiritide is used for nearly 10% of heart failure-related hospitalizations. Although it promptly improves symptoms of heart failure, the long-term safety of nesiritide has not been established by a prospective, long-term clinical outcomes trial. Nesiritide is manufactured by Scios, a unit of Johnson and Johnson.
About Acutely Decompensated Heart Failure
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. Typically, patients are hospitalized with organ congestion, an indicator that there is excess fluid present. Symptoms can include severe shortness of breath, especially with activity or when lying down. The cornerstone of therapy is the use of diuretics.
North Shore University Hospital; University of Michigan
CONTACT: Elaine Wohl, North Shore-LIJ, +1-516-465-2600; Kara Gavin,University of Michigan, +1-734-764-2220
Web site: http://www.northshorelij.com/