Use of nesiritide doesn't help or hinder, study shows

July 22, 2011

Nesiritide cannot be recommended in the broad population of patients with acute decompensated heart failure, according to the results of a recent study published in the New England Journal of Medicine.

Nesiritide cannot be recommended in the broad population of patients with acute decompensated heart failure, according to the results of a recent study published in the New England Journal of Medicine.

The Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF) trial was designed to evaluate the safety and efficacy of the drug. Primary end points included the change in dyspnea at 6 and 24 hours, as measured on a 7-point Likert scale, as well as the composite end point of rehospitalization for heart failure or death within 30 days, and renal dysfunction. The trial was conducted from May 2007 through August 2010 at 398 centers throughout the world.

More than 7,000 patients who were hospitalized with acute heart failure were randomly assigned to receive either nesiritide or placebo for 24 to 168 hours in addition to standard care.

According to the results, the observed effect of nesiritide on dyspnea in this trial was small and not significant. Patients in the nesiritide group more frequently reported an improvement in dyspnea at 6 hours (44.5% vs 42.1%, P=.03) and 24 hours (68.2% vs 66.1%, P=.007). And the drug neither increased nor decreased the rate of death and rehospitalization. The rate of rehospitalization for heart failure or death from any cause within 30 days was 9.4% in the nesiritide group versus 10.1% in the placebo group.

The authors mentioned that nesiritide was quickly approved and adopted in 2001 because of its perceived benefit in relieving dyspnea and congestion; however its use noticeably decreased after a published meta-analyses reported a detrimental effect on survival and renal function. “Our study showed that neither belief was accurate. The results of this trial highlight the urgent need for rigorously designed trials with adequate power to provide reliable estimates that can replace incomplete or inadequate evidence as a basis for therapeutic decisions,” the authors concluded.