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Increased Risk of Mortality with Nesiritide for Decompensated Heart Failure 

May 25, 2005

Manhasset, NY- Nesiritide is a recombinant form of human B-type natriuretic peptide (hBNP) that improves symptoms in patients with acutely decompensated heart failure. It was approved by the US Food and Drug Administration (FDA) based on its ability to reduce symptoms of dyspnea and left ventricular filling pressure relative to placebo within 3 hours of administration. A pooled analysis of randomized controlled trials was studied by Jonathan Sackner-Bernstein M.D. et al from Northshore University Hospital in New York and published in the April 20, 2005 issue of The Journal of American Medical Association. The study concluded that nesiritide may be associated with an increased risk of death after treatment for acutely decompensated heart failure. 

Previous studies have shown nesiritide to be associated with a heightened risk of renal failure. To determine if this worsening of renal failure is associated with an increased risk of death, this study pooled available individual patient data from completed randomized controlled trials to determine the safety of nesiritide therapy. Three randomized, double-blind controlled trials used noninotrope-based control therapy and provided at lease 30-day follow- up of the patientís status. The three studies were the Nesiritide Study Group Efficacy Trial (NSGET), Vasodilation in the Management of Acute Congestive heart failure (VMAC) and the Prospective Randomized Outcomes Study of Acutely Decompensated Congestive Heart Failure Treated initially in Outpatients with Natrecor (PROACTION).  

The crude risk of mortality within the first 30 days after randomization was significantly higher for patients in VMAC than for patients in PROACTION (36 [7.2%] of 498 vs. 6 [2.5%] of 237 patients; RR, 2.86; 95% CI 1.22-6.67; P=0.01). The intermediate risk group was NSGET (8 [6.3%] of 127 patients; RR 2.49; 95% CI, 0.88-7.01; P=0.09). The crude 30 day mortality was higher for nesiritide than for control therapy (35 [7.2%] of 485 vs. 15 [4.0%] pf 377; RR, 1.81; 95% CI, 1.01-3.27; P=0.04). Meta-analysis suggested a higher risk with nesiritide therapy (RR 1.74; 95% CI, 0.97-3.12; P=0.059) 

The three trials in these analyses are the only double-bind studies to evaluate the 30- day outcomes associated with nesiritide therapy for patients with acutely decompensated heart failure. The analysis of these studies suggests nesiritide therapy may be associated with meaningful mortality risk. Although there is an association between nesiritide and increased mortality, a more adequately powered prospective trial is necessary for definitive results.  

The possibility of this risk implies that nesiritide may not be an optimal choice as first-line therapy for acutely decompensated heart failure. This study advises to consider reserving use of this agent to situations in which a combination of diuretics and nitroglycerin has proven inadequate.  

Co-authors: Marcin Kowalski, MD, Marshal Fox MD, Keith Aaronson, MD, MS 

 


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