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Vascular Disorders
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my personal edition > vascular disorders > news
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DGNews
Research Suggests Nesiritide Improves Postoperative Renal Function and Potentially Enhances Survival After Coronary Artery Bypass Grafting
DETROIT, MI -- February 5, 2007 -- Natrecor® (nesiritide), a compound developed by Scios, Inc., may be beneficial in the prevention of renal dysfunction after coronary artery bypass grafting requiring cardiopulmonary bypass, suggests "Effects of Perioperative Nesiritide in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery: The NAPA Trial."
The study will be published in the February 13 issue of the Journal of the American College of Cardiology.
Patients in the study were experiencing heart failure and had limited treatment options. Those taking Natrecor® (nesiritide) had improved outcomes, including shorter hospital stays and a statistically significant decrease in mortality rate after 180 days than patients receiving the placebo, determined the Scios-sponsored study.
"We discovered a statistically significant number of patients who received Natrecor® and recovered better than those who received the placebo," said principal investigator Robert M. Mentzer, Jr., MD, FACC. Dr. Mentzer is dean of the medical school at Wayne State University, senior advisor to the president for medical affairs and is a professor in the Division of Cardiothoracic Surgery, Department of Surgery. He added, "Patients on nesiritide had significantly greater urine output within 24 hours after surgery and overall better preservation of kidney functioning during hospitalization as well as two weeks after surgery."
The prospective, multi-center, double-blind Phase 2 NAPA (Nesiritide Administered Peri-Anesthesia in Patients Undergoing Cardiac Surgery) trial of 279 randomized patients was designed to determine the role Natrecor® (nesiritide) may play in the management of patients with left ventricular dysfunction undergoing coronary artery bypass grafting (CABG) that required cardiopulmonary bypass.
"These kidney, safety and mortality findings from the NAPA trial are encouraging as they suggest that nesiritide may provide important clinical benefit to heart failure patients undergoing CABG surgery with cardiopulmonary bypass," said Roger Mills, MD, vice president, medical affairs at Scios. "We are assessing the design of a Phase 3 trial in cardiac surgery patients to further study this investigational use of nesiritide and will be submitting these data to the FDA."
Dr. Mentzer conducted the research and authored the paper with Mehmet C. Oz, MD, F.A.C.C., Division of Cardiothoracic Surgery, College of Physicians and Surgeons, Columbia University; Robert N. Sladen, MD, FCCM, Department of Anesthesiology, College of Physicians and Surgeons, Columbia University; Allen H. Graeve, MD, FACS, Multicare Cardiothoracic Surgical Associates, Tacoma General Hospital; Robert F. Hebeler, Jr., MD, Department of Surgery, Baylor University Medical Center; John M. Luber, Jr., MD, FACS, Franciscan Health System Research Center, Tacoma; and Nicholas G. Smedira, MD, FACC, Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic.
About Natrecor® (nesiritide)
Natrecor®, added to standard therapy, is the only approved treatment for Acutely Decompensated Heart Failure (ADHF) that has shown improvement in difficulty breathing and reduction of elevated wedge pressures in the lungs in controlled clinical trials. Natrecor® has been studied in 15 clinical trials involving 1,407 patients treated with the drug, and has been used to treat thousands of acutely decompensated heart failure patients.
Natrecor® is indicated for the intravenous treatment of patients with ADHF who have difficulty breathing at rest or with minimal activity. In this population, the use of Natrecor® reduced pulmonary capillary wedge pressure and improved patient reported difficulty in breathing. For full prescribing information, visit www.natrecor.com.
SOURCE: Wayne State University School of Medicine
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