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September 27, 2006

Risk of Death Associated With Nesiritide in Patients With Acutely Decompensated Heart Failure

JAMA. 2006;296(12):1461-1466. doi:10.1001/jama.296.12.1465

To the Editor: A pooled analysis of all randomized clinical trials assessing nesiritide in patients with acutely decompensated heart failure found a nonstatistically significant association between use of nesiritide and increased risk of death within 30 days.1 The analysis included the Nesiritide Study Group Efficacy Trial (NSGET),2 the Vasodilation in the Management of Acute Congestive Heart Failure (VMAC) study,3 and the Prospective Randomized Outcomes Study of Acutely Decompensated Congestive Heart Failure Treated Initially in Outpatients With Natrecor (PROACTION).4 Scios Inc subsequently identified 2 additional deaths within 30 days of treatment in PROACTION, both in patients randomized to nesiritide.5 We repeated the original analysis and included these 2 deaths. We also performed an analysis limited to the VMAC study and PROACTION, the trials that used the currently recommended starting dose of nesiritide.

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