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From rxpgnews.com CTVS
Patients in the study were experiencing heart failure and had limited treatment options. Those taking Natrecor(R) 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 study sponsored by Scios Inc. "We discovered a statistically significant number of patients who received Natrecor(R) and recovered better than those who received the placebo," said principal investigator Robert M. Mentzer, Jr., M.D., F.A.C.C. 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(R) (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, M.D., 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 F.D.A." All rights reserved by RxPG Medical Solutions Private Limited ( www.rxpgnews.com ) |
