Natrecor nesiritide: Phase III
In SCIO's 498-patient U.S. Phase III Vasodilation in the Management of Acute CHF (VMAC) study, Natrecor gave a significant improvement in pulmonary capillary wedge pressure (PCWP) at 3 hours, the primary end point, compared to placebo or intravenous nitroglycerin (p<0.05 for both). In addition, Natrecor-treated patients showed a significant improvement in dyspnea (breathing difficulty) compared to patients on placebo (p=0.034), but not compared to those on nitroglycerin. Natrecor also significantly improved pulmonary arterial pressure (PAP) at 3 hours versus nitroglycerin (p<0.05). No difference in estimated 30-day survival was seen between the Natrecor and nitroglycerin groups.
In VMAC, Natrecor was given as a starting dose of a 2 ug/kg bolus and a 0.01 ug/kg/min infusion for a median of 24 hours. A total of 46 percent of VMAC patients had a previous heart attack. Significantly fewer adverse events were seen with Natrecor versus nitroglycerin during the first 24 hours, with 51 percent of Natrecor patients experiencing an adverse event compared to 68 percent of nitroglycerin patients (p<0.001). However, symptomatic hypotension occurred at the same rate in the Natrecor and nitroglycerin groups. ...