Nesiritide increases risk of death in decompensated HF

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Nesiritide increases risk of death in decompensated HF Nesiritide appears to increase the risk of death within 30 days of its use, even at the recommended starting dose, in patients with acutely decompensated heart failure (HF), according to US-based researchers. To determine the risk of death within 30 days of nesiritide use, they performed a revised analysis of a meta-analysis of the VMAC study, NSGET and PROACTION* involving patients with acutely decompensated HF who were randomised to receive nesiritide (n = 485) or control therapy (377); two additional deaths from PROACTION were included.** A subanalysis was performed limited to the VMAC study and PROACTION that used the currently recommended starting dose of nesiritide. At 30 days, the crude mortality rate was higher in the nesiritide group than in the control group (7.6% vs 4.0%). When restricted to the VMAC study and PROACTION, the mortality rate was 7.8% and 3.9% in the nesiritide and control groups, respectively. The risk of death in the nesiritide group was significantly higher than in the control group (study-adjusted relative risk [RR] 1.86; 95% CI 1.05, 3.27); the corresponding studyadjusted hazard ratio (HR) was 1.93 (95% CI 1.06, 3.52). When restricted to the VMAC study and PROACTION, the study-adjusted RR (1.93; 1.05, 3.54) and a studyadjusted HR (2.00; 1.05; 3.83) for death remained significantly increased in the nesiritide group than in the control group. See also Reactions 1049 p4; 800996284 * the Vasodilation in the Management of Acute Congestive Heart Failure (VMAC), the Nesiritide Study Group Efficacy Trial (NSGET) and the Prospective Randomized Outcomes Study of Acutely Decompensated Congestive Heart Failure Treated Initially in Outpatients With Natrecor (PROACTION) ** Scios Inc subsequently identified two additional deaths that occurred within 30 days of treatment in nesiritide recipients. Aaronson KD, et al. Risk of death associated with nesiritide in patients with acutely decompensated heart failure. JAMA: the Journal of the American Medical 801034286 Association 296: 1465-1466, No. 12, 27 Sep 2006

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Reactions 7 Oct 2006 No. 1122