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.
|
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)
Natrecor for Pulmonary Hypertension in Lung Transplants [Completed]
This study seeks to demonstrate that Natrecor® (nesiritide) is safe and effective and has a
favorable hemodynamic profile in lung transplant recipients that will allow for the
avoidance of inhaled nitric oxide (iNO) use. It is estimated that the use of nesiritide
will decrease the otherwise historically mandated use of iNO by 50%, as compared to the
necessity of iNO use by matched historical controls.
Natriuretic Peptide System as Therapy in Human Preclinical Left Ventricle Dysfunction [Completed]
In congestive heart failure, cardiac output is low, blood pressure is high, and the body
becomes congested with fluid. In normal people, when there is high blood pressure, the heart
muscle cells secrete a hormone that excretes sodium and water in the urine, reducing blood
pressure. The action of this hormone is called the natriuretic response. The purpose of this
study is to determine if nesiritide can improve an impaired natriuretic response in subjects
with asymptomatic systolic heart failure or asymptomatic diastolic heart failure.
Double Blind Randomized Placebo Controlled Trial of Natrecor in Acute Decompensated Heart Failure With Normal EF [Withdrawn]
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.
Natrecor in Pulmonary Hypertension [Terminated]
The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is
effective in lowering the pressure in your lungs.
The primary objective of this study is to establish that Nesiritide (Natrecor) is effective
in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean
pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in
pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of
toxicity, and surgeon's willingness to proceed with operation.
Use of Nesiritide in the Management of Acute Diastolic Heart Failure [Terminated]
Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV)
filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of
patients admitted with acute diastolic heart failure.
Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in
Doppler diastolic filling parameters in patients with diastolic heart failure.
|
