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Drug Evaluation

Nesiritide for the treatment of decompensated heart failure

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Pages 803-813 | Published online: 10 Jan 2014

References

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  • Natrecor®, Prescribing Information for nesiritide. Scios Inc., CA, USA (2001).
  • •Standard prescribing information monograph.
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  • •Isolated the hemodynarnic effects of nesiritide by replacing urinary fluid losses.
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  • ••Early study documenting the multiplephysiologic effects of B-type natriuretic peptide (BNP) in patients with chronic heart failure.
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  • •Demonstrates the utility of BNP in the diagnosis of chronic heart failure.
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  • ••Excellent review of thepharmacodynamics and clinical effects of BNP.
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  • •Small study demonstrating increased coronary blood flow with nesiritide.
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  • •Analysis of the Prospective Randomized Evaluation of Cardiac Ectopy with DobutaminE or Natrecor Therapy (PRECEDENT) trial. Demonstrates that nesiritide decreases endothelin-1 levels.
  • Brunner-La Rocca HP, Kaye DM, Woods RL, Hastings J, Esler MD. Effects of intravenous brain natriuretic peptide on regional sympathetic activity in patients with chronic heart failure, compared with healthy control subjects. J. Am. Coll. Cardiol. 37(5), 1221–1227 (2001).
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  • ••The Nesiritide Study Group trial was thefirst Phase III trial of nesiritide proving hemodynamic and clinical benefit versus placebo in patients with decompensated heart failure.
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  • Publication Committee for the VMAC Investigators. Intravenous nesiritide vs. nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial. I Am. Med. Assoc. 287(12), 1531–1540 (2002).
  • ••The Vasodilation in the Management of Acute Chronic heart failure trial compared nesiritide with nitroglycerin and placebo for decompensated congestive heart failure. It is the largest published trial of nesiritide.
  • Mills RM, LeJemtel TH, Horton DP et al. Sustained hemodynamic effects of an infusion of nesiritide (human b-type natriuretic peptide) in heart failure: a randomized, double-blind, placebo-controlled clinical trial. Natrecor Study Group. J. Arn. Coll. Cardia1.34(1), 155–162 (1999).
  • •Phase II trail demonstrated that the effects of nesiritide are dose dependent and can be sustained for 24 h.
  • Chen HH, Grantham JA, Schirger JA et al. Subcutaneous administration of brain natriuretic peptide in experimental heart failure. J. Am. Coll. Cardiol. 36(5), 1706–1712 (2000).
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  • ••First report of the efficacy of subcutaneousadministration of nesiritide.
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  • Silver MA, Horton DP, Ghali JK, Elkayam U. Effect of nesiritide versus dobutamine on short-term outcomes in the treatment of patients with acutely decompensated heart failure. J. Am. Coll. Cardiol. 39(5), 798–803 (2002).
  • Peacock WF IV, Emerman CL, Young J. Nesiritide in congestive heart failure associated with acute coronary syndromes: a pilot study of safety and efficacy. J. Card. Fail. 10(2), 120–125 (2004).
  • Burger AJ, Horton DP, LeJemtel T et al. Effect of nesiritide (B-type natriuretic peptide) and dobutamine on ventricular arrhythmias in the treatment of patients with acutely decompensated congestive heart failure: the PRECEDENT study. Am. Heart J. 144(6), 1102–1108 (2002).
  • ••PRECEDENT study demonstrated a lower rate of ventricular ectopy with nesiritide compared with dobutarnine.
  • Burger AJ, Elkayam U, Neibaur MT et al. Comparison of the occurrence of ventricular arrhythmias in patients with acutely decompensated congestive heart failure receiving dobutamine versus nesiritide therapy. Am. Cardiol 88(1), 35–39 (2001).
  • •Subgroup analysis that demonstrates increased ventricular arrythrnias with dobutarnine than nesiritide.
  • de Lissovoy G, Stier DM, Ciesla G, Munger M, Burger AJ. Economic implications of nesiritide versus dobutamine in the treatment of patients with acutely decompensated congestive heart failure. Am. J Cardiol 92(5) 631–633 (2003).
  • Lewis DA, Gurram NR, Abraham WT, Akers WS. Effect of nesiritide versus milrinone in the treatment of acute decompensated heart failure. Am. J Health Syst. Pharm. 60\(Suppl. 4) S16—S20 (2003). •Retrospective study demonstrates the lower cost and decreased intensive care unit stay with nesiritide versus milrinone.
  • Yancy CW, Saltzberg MT, Berkowitz RL et al Safety and feasibility of using serial infusions of nesiritide for heart failure in an outpatient setting (from the FUSIONI trial). Am. J Cardiol 94(5), 595–601 (2004).
  • ••Follow-Up Serial Infusions Of Nesiritide(FUSION) study demonstrated the feasibility of outpatient administration of nesiritide.
  • Altschul L, Masciello M, Massaro G. Sustained benefits in patients treated with intermittent infusions of nesiritide in an outpatient setting. J. Card. Fail. 9 (Suppl. 1), 5110 (2003).
  • Altschul L, Masciello M, Massaro G. Intermittent outpatient use of nesiritide reduces hospitalizations in patients with advanced congestive heart failure. J. Card. Fail. 9 (Sunni. 1), S109 (2003).
  • Mulki GM, Pisano C, Gallagher C et al. Safety and efficacy of intermitten, short-term, outpatient nesiritide infusions for the treatment of decompensated heart failure. J Card. Fail. 9 (Sunni. 1), S68 (2003).
  • Peacock WE Heart failure management in the emergency department observation unit. Frog. Cardiovasc. Dis. 46(5), 465–485 (2004).
  • Peacock WF, Emerman CE, Young JB, on behalf of the PROACTION study group. Safety and efficacy of nesiritide for the treatment of decompensated heart failure in emergency department observation unit patients. J Am. Coll. Cardiol. 41 (Suppl. A), 336A (2003) (Abstract).
  • ••Abstract reporting the results of theProspective Randomized Outcomes study of Acutely decompensated Chronic heart failure Treated Initially in Outpatients with Natrecor (PROACTION) trial of nesiritide use in the emergency department observation unit.
  • Peacock WE Clinical and economic impact of nesiritide. Am. J Health Syst. Pharm. 60\(Suppl. 4), S21—S26 (2003).
  • Sackner-Bernstein J, Kowalski M, Fox M. Is there risk associated with the use of nesiritide for acute heart failure? J. Arn. Coll. Cardiol 41(Suppl. A), A161 (2003).
  • Schaeffer MW Conway GA, Bell BJ, Giesting RM, Wagoner LE. Nesiritide improves pulmonary artery hypertension in end stage heart failure patients awaiting transplantation. J Card. Fail. 9 (Suppl. 1), S108 (2003).

Websites

  • Information on Natrecor® for healthcare providers from Scios Inc. www.natrecor.com/natrecor-professional_chf (Accessed October 2004)

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