title: Nesiritide for acute decompensated heart failure: does the benefit justify the risk?
abstract: Nesiritide is US Food and Drug Administration-approved for the treatment of patients with acutely decompensated heart failure who suffer from symptoms at rest or with minimal exertion. Its approval was based on a clinical development program that focused on surrogates and short-term effects on symptoms rather than clinical outcomes. The association between its use and subsequent risk of death raises the question of whether the endpoints assessed in the clinical development program were adequate, and provides the opportunity to evaluate the process of weighing risks with benefits. We conclude that with nesiritide, the risks of therapy outweigh the benefits demonstrated to date.
authors.affiliation: Clinilabs, Inc., 423 West 55th Street, 4th Floor, New York, NY 10019, USA. jsb@clinilabs.com
authors.forename: Jonathan
authors.initials: J
authors.lastname: Sackner-Bernstein
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
mesh_terms: D000208:Acute Disease; D000818:Animals; D015415:Biomarkers; D002986:Clinical Trials as Topic; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D045283:Natriuretic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D020097:Natriuretic Peptide, Brain / Q000009:adverse effects* / Q000627:therapeutic use; D051437:Renal Insufficiency / Q000139:chemically induced*; D012307:Risk Factors
chemical_list: D015415:Biomarkers; D045283:Natriuretic Agents; D020097:Natriuretic Peptide, Brain