NATRECOR SUMMARY
Natrecor® (nesiritide) is a sterile, purified preparation of a new drug class, human B-type natriuretic peptide (hBNP), and is manufactured from E. coli using recombinant DNA technology. Nesiritide has a molecular weight of 3464 g/mol and an empirical formula of C143H244N50O42S4. Nesiritide has the same 32 amino acid sequence as the endogenous peptide, which is produced by the ventricular myocardium.
Natrecor (nesiritide) is indicated for the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity. In this population, the use of Natrecor reduced pulmonary capillary wedge pressure and improved dyspnea.
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NEWS HIGHLIGHTS
Published Studies Related to Natrecor (Nesiritide)
The ASCEND-HF trial: an acute study of clinical effectiveness of nesiritide and
decompensated heart failure. [2012]
Nesiritide has been approved by the US FDA for the treatment of acute
decompensated heart failure since 2001. Subsequently, two meta-analyses
questioned its impact on mortality and association with worsening renal function... In this article, the important findings and lessons learned from this
landmark study are reviewed and potential evolving roles for nesiritide and
natriuretic peptides in the future of heart failure therapy are proposed.
Mode of death and hospitalization from the Second Follow-up Serial Infusions of Nesiritide (FUSION II) trial and comparison of clinical events committee adjudicated versus investigator reported outcomes. [2011.11.15]
The aim of this study was to evaluate the mode of death and hospitalizations in advanced heart failure (HF) patients with renal dysfunction and to examine the rate of concordance between events reported by the clinical events committee and site investigators (using case report forms) in the Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial...
Effect of nesiritide in patients with acute decompensated heart failure. [2011.07.07]
BACKGROUND: Nesiritide is approved in the United States for early relief of dyspnea in patients with acute heart failure. Previous meta-analyses have raised questions regarding renal toxicity and the mortality associated with this agent... CONCLUSIONS: Nesiritide was not associated with an increase or a decrease in the rate of death and rehospitalization and had a small, nonsignificant effect on dyspnea when used in combination with other therapies. It was not associated with a worsening of renal function, but it was associated with an increase in rates of hypotension. On the basis of these results, nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure. (Funded by Scios; ClinicalTrials.gov number, NCT00475852.).
Modulation of novel cardiorenal and inflammatory biomarkers by intravenous nitroglycerin and nesiritide in acute decompensated heart failure: an exploratory study. [2011.07]
CONCLUSIONS: The differential modulation effects of cystatin-C and interleukin-6 but not other inflammatory markers, in response to NES compared with NTG therapy, may provide important implications for vasodilator therapy. Further studies are warranted to confirm these findings. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00842023.
Acute study of clinical effectiveness of nesiritide in decompensated heart
failure: nesiritide redux. [2011]
Nesiritide, a synthetic drug form of human B-type natriuretic peptide, is
approved for the early treatment of dyspnea in acute decompensated heart failure. Meta-analyses suggested a risk of worsening renal insufficiency and mortality
with its use... We recommend the continued use of nesiritide in acute decompensated heart
failure as an individualized case-based therapy to those patients who meet
criteria for treatment and are expected to receive benefit from its use.
Clinical Trials Related to Natrecor (Nesiritide)
Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction [Recruiting]
Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery [Recruiting]
The staged surgical pathway to treat children with single ventricle heart defects culminates
with the Fontan operation. In this procedure, systemic venous return is rerouted directly to
the pulmonary arteries, which serves to separate the systemic and pulmonary circulations.
Although mortality following the Fontan operation is now uncommon, early postoperative
morbidity including prolonged postoperative chest tube drainage and hospitalization remains
significant. The efficacy of empiric inotropic, vasodilator and neurohumoral-inhibitory
therapies in the perioperative period is unknown and practice varies widely between centers.
The investigators will propose a single-center, randomized, double-blind, phase II clinical
trial in children undergoing Fontan surgery. The investigators plan to compare the effects
of perioperative nesiritide, milrinone and placebo infusions on the early postoperative
clinical course and neurohumoral profile. The investigators hypothesize that, when compared
to the milrinone and placebo groups, the nesiritide group will have more days alive and out
of the hospital within the first 30 days after surgery.
Double Blind Randomized Placebo Controlled Trial of Natrecor in Acute Decompensated Heart Failure With Normal EF [Not yet recruiting]
Heart failure (HF) is a disease that is caused by a reduced heart muscle function. Reduced
heart muscle function can occur as a consequence of reduced pumping activity from a weak
heart muscle or because of a stiff heart muscle. This study is looking at the effectiveness
of Natrecor (nesiritide) in patients that require hospitalization due to worsening heart
failure as a result of a stiff or thickened heart muscle. Natrecor is a man-made version of
a protein that my body makes on its own and has been approved for the treatment of patients
requiring hospital admission for heart failure and have shortness of breath at rest or with
minimal activity.
Natrecor has shown to lower the pressures in the heart and decreases the congestion in the
lungs. This study is being done to see if the addition of a Natrecor to standard medical
therapy for HF will improve symptoms faster or more completely than giving only the standard
treatment for CHF.
The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure [Recruiting]
Renal Optimization Strategies Evaluation in Acute Heart Failure [Recruiting]
The purpose of this study is to determine the benefits and safety of intravenous
administration of low dose nesiritide or low dose dopamine in patients with congestive heart
failure and kidney dysfunction.
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