Nesiritide and heart failure

Nesiritide can no longer be recommended for use in congestive heart failure based on the findings of a new study. The drug is a recombinant B-type naturetic peptide (BNP) that was approved in 2001 for use in patients with acute heart failure. The approval was based on small studies showing a reduction in pulmonary capillary wedge pressure and improvement in dyspnea 3 hours after administration. However, subsequent data raised questions about the drug's safety, especially with regard to worsening renal function and even increased mortality. Based on the recommendations of an independent panel, the manufacturer performed a placebo-controlled randomized trial of more than 7000 patients hospitalized with acute heart failure to assess the drug's safety and efficacy. Patients with heart failure were randomized to receive nesiritide or placebo for 24-168 hours in addition to standard care. The drug was modestly effective at reducing symptoms of dyspnea at 6 and 24 hours. More significantly, however, the rate of rehospitalization for heart failure or death from any cause within 30 days was no different. Nesiritide was not associated with a worsening of renal function but was associated with worsening hypotension. The authors conclude that on the basis of these results, "nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure" (N Engl J Med 2011;365:32-43).