Nesiritide

From Wikipedia, the free encyclopedia
  (Redirected from Natrecor)
Jump to navigation Jump to search
Nesiritide
Nesiritide.svg
Clinical data
AHFS/Drugs.comMonograph
Routes of
administration
IV only
ATC code
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
ChEMBL
Chemical and physical data
FormulaC143H244N50O42S4
Molar mass3464 g/mol
3D model (JSmol)
 ☒N☑Y (what is this?)  (verify)

Nesiritide (Natrecor) is the recombinant form of the 32 amino acid human B-type natriuretic peptide, which is normally produced by the ventricular myocardium. Nesiritide works to facilitate cardiovascular fluid homeostasis through counterregulation of the renin–angiotensin–aldosterone system, stimulating cyclic guanosine monophosphate, leading to smooth muscle cell relaxation.

Nesiritide was believed initially to be beneficial for acute decompensated congestive heart failure. It received approval from the United States' Food and Drug Administration for this purpose in 2001 after initial non-approval. In July 2011 the results of the largest study so far for nesiritide was published in The New England Journal of Medicine. The study failed to show a difference between nesiritide and placebo on mortality or re-hospitalizations.[1]

Administration[edit]

Nesiritide is only administered intravenously, usually by bolus, followed by IV infusion. For most adults and the elderly, a normal dosage is 2 mg/kg followed by a continuous IV infusion of 0.01 mg/kg/min. This may be increased every three hours for a maximum of 0.03 mg/kg/min.

Controversy[edit]

In 2005, after several academic papers published by Jonathan Sackner-Bernstein[2][3][4] on the efficacy and side effects of Nesiritide, Johnson & Johnson met with the FDA and altered its stated plans for the drug and agreed to revise its labeling.[5][6]

Heart doctors at the Cleveland Clinic then voted unanimously not to permit the prescription of the drug to its patients.[7] Johnson and Johnson convened a panel of experts whose advice included the recommendation to conduct the large scale clinical trial that was subsequently published in 2011.[8] Following this, the United States Department of Justice announced an inquiry into the marketing of the drug[9] that led to a fine against the Scios unit of J&J.[10]

Side effects[edit]

Common side effects include:

More rare side effects include:

References[edit]

  1. ^ O'Connor (2011). "Effect of nesiritide in patients with acute decompensated heart failure". New England Journal of Medicine. 365 (32): 32–43. doi:10.1056/NEJMoa1100171. PMID 21732835.
  2. ^ http://circ.ahajournals.org/content/111/12/1487.short
  3. ^ Sackner-Bernstein, Jonathan D.; Kowalski, Marcin; Fox, Marshal; Aaronson, Keith (2005-04-20). "Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials". JAMA. 293 (15): 1900–1905. doi:10.1001/jama.293.15.1900. ISSN 1538-3598. PMID 15840865.
  4. ^ Aaronson, Keith D.; Sackner-Bernstein, Jonathan (2006-09-27). "Risk of death associated with nesiritide in patients with acutely decompensated heart failure". JAMA. 296 (12): 1465–1466. doi:10.1001/jama.296.12.1465. ISSN 1538-3598. PMID 17003394.
  5. ^ https://www.nytimes.com/2005/05/17/business/the-marketing-and-success-of-natrecor.html?_r=0
  6. ^ https://query.nytimes.com/gst/fullpage.html?res=9D0CE4D81630F937A35756C0A9639C8B63
  7. ^ https://query.nytimes.com/gst/fullpage.html?res=9D0CE4D81630F937A35756C0A9639C8B63
  8. ^ https://www.forbes.com/2005/06/14/johnson-and-johnson-pharmaceuticals-safety-cx_mh_0614jnj.html#69beb7877a1f
  9. ^ https://www.nytimes.com/2005/07/21/business/us-looking-at-marketing-by-johnson-johnson.html
  10. ^ https://www.justice.gov/opa/pr/johnson-johnson-subsidiary-scios-pleads-guilty-misbranding-heart-failure-drug-natrecor
  11. ^ https://online.epocrates.com/noFrame/showPage.do?method=drugs&MonographId=2511&ActiveSectionId=5

Science or Fiction: Use of Nesiritide as a First-Line Agent? John A. Noviasky, Pharm.D., Michael Kelberman, M.D., Karen M. Whalen, B.S., Roy Guharoy, Pharm.D., William Darko, Pharm.D.[1]

External links[edit]