Assignment: a phase III, double-blind, randomised controlled trial.Retrieved

Assignment: 01

There is a requirement of new treatment for severely sick patients who don’t sufficiently react to marketed vasopressors, stated by Rinaldo Bellomo, M.D., Professor of Intensive Care Medicine at the University of Melbourne and Director of Intensive Care Research at Austin Health.
In ATHOS-3 (The Angiotensin II for the Treatment of High-Output Shock), angiotensin II was appeared to elevate blood pressure without a significant increase in the rate of adverse events when compared to placebo in resistant patient population. 
The impact of angiotensin II brought about declined utilization of other vasopressors. Upon approval, angiotensin II, in conjugation with other vasopressors, may enable clinicians for utilization of the all three major physiologic systems which regulates blood pressure.

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General Description:

Generic Name:

(Synthetic human) angiotensin II

Brand Name:

GIAPREZA

Manufacturer:

La Jolla Pharmaceutical Company

NDA Number:

209360

Strength(Dose): 

2.5 mg/mL & 5mg/2mL

Dosage form:

Sterile solution

Route of Administration:

Injection (Infusion)

Marketing Status:

Prescription

Date of Approval:

December 21, 2017

Indication for Use: 
GIAPREZA is used to elevate blood pressure in adults with septic and/or other distributive shocks. It acts as “vasoconstrictor”.

Mechanism of Action:
A blood pressure is raised by Angiotensin II by acting as a vasoconstriction and also increases the release of aldosterone. This action on the wall of the vessel is mediated by binding to G-protein coupled angiotensin II receptor type I on the vascular smooth muscle cell which causes stimulation of Ca2+/calmodulin dependent phosphorylation of myosin and it causes contraction of smooth muscles.

References:

Results of ATHOS-3 Phase 3 Study of LJPC-501 Published in The New England Journal of Medicine. Retrieved on January 24, 2018, from https://www.drugs.com/clinical_trials/results-athos-3-phase-3-study-ljpc-501-published-new-england-journal-medicine-17517.html
[email protected]: FDA Approved Drug Products. Retrieved on January 24, 2018, from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process=209360
Angiotensin II for the Treatment of High-Output Shock 3 (ATHOS-3): protocol for a phase III, double-blind, randomised controlled trial.Retrieved on January 24, 2018, from https://www.ncbi.nlm.nih.gov/pubmed/28215131
The Angiotensin II for the treatment of high-output Shock-3 Trial (Athos-3).Retrieved on January 24, 2018, from http://www.j-pcs.org/article.asp?issn=2395-5414;year=2017;volume=3;issue=2;spage=103;epage=105;aulast=Ghati
ANGIOTENSIN II FOR THE TREATMENT OF VASODILATORY SHOCK.Retrieved on January 24, 2018, from http://www.esicm-old.org/news-article/ARTICLE-REVIEW-angiotensin-ii-for-vasodilatory-shock-JUNE-2017
FDA approves drug to increase blood pressure in adults with septic or distributive shock.Retrieved on January 24, 2018, from https://www.news-medical.net/news/20171221/FDA-approves-drug-to-increase-blood-pressure-in-adults-with-septic-or-distributive-shock.aspx
ATHOS-3: A New Vasopressor For Treatment of Vasodilatory Shock?Retrieved on January 24, 2018, from http://rebelem.com/athos-3-a-new-vasopressor-for-treatment-of-vasodilatory-shock/

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