July 7th, 2011

ASCEND-HF: No Harm or Benefit with Nesiritide

With the publication of the final results of the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial in the New England Journal of Medicine, the once intense controversy over the use — or misuse — of the drug nesiritide in patients with acute decompensated heart failure has finally been resolved. The results, which were first presented last November at the AHA, demonstrate unequivocally that the drug was neither harmful nor beneficial.

CM O’Connor and colleagues randomized 7,141 patients with acute HF to either nesiritide or placebo. The primary endpoin t– the rate of rehospitalization or death within 30 days — occurred in 9.4% of patients in the nesiritide group versus 10.1% of patients in the placebo group (CI −2.1 to 0.7, p=0.31).

The investigators concluded that “on the basis of these results, nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure.” Noting the early widespread use of the drug despite the lack of evidence, the authors wrote that “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.”

In an accompanying editorial, Eric Topol writes about the “lost decade” from the time of FDA approval of nesiritide to the publication of the trial, in which “well more than $1 billion was wasted on purchasing the drug.”

After the presentation last November of the initial trial results, Eugene Braunwald told CardioExchange: “I don’t see much of a future for nesiritide.”

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