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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.

Methods

Crude risk of death at 30 days was compared by calculating a risk ratio with a 95% confidence interval . . . [Full Text of this Article]

Keith D. Aaronson, MD, MS
University of Michigan
Ann Arbor

Jonathan Sackner-Bernstein, MD
jonathansb@yahoo.com
Clinilabs Inc
New York, NY

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