Document Detail


Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile.
MedLine Citation:
PMID:  16734808     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In recent years, the hemostatic agent recombinant factor VIIa (rFVIIa) has emerged as a potentially new therapeutic agent for management of coagulopathy in patients with cirrhosis or following severe traumatic injury, a complex problem for clinicians in which standard treatment strategies are not always effective. As with other hemostatic agents, a primary safety concern of rFVIIa therapy is the theoretical possibility that systemic administration could confer an increased risk of thrombotic complications. So far, clinical experience indicates rFVIIa to be a safe treatment for currently approved indications within hemophilia. Little information is available, however, for patient populations outside this clinical setting. STUDY DESIGN AND METHODS: This article reviews critical safety data obtained from 13 Novo Nordisk-sponsored clinical trials of rFVIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury. RESULTS: Thrombotic adverse events were reported for 5.3 percent (23/430) of placebo-treated patients and 6.0 percent (45/748) of patients on active treatment. No significant difference was found between placebo-treated and rFVIIa-treated patients with respect to the incidence of thrombotic AEs, either on an individual trial basis or for these trial populations combined (p=0.57). CONCLUSION: An important determinant for the safety profile reported here is likely to be the specific mechanism of action of rFVIIa, shown in experimental studies to be localized to the site of vascular injury where tissue factor is exposed.
Authors:
Jerrold H Levy; Abe Fingerhut; Thomas Brott; Irene H Langbakke; Elisabeth Erhardtsen; Robert J Porte
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Transfusion     Volume:  46     ISSN:  0041-1132     ISO Abbreviation:  Transfusion     Publication Date:  2006 Jun 
Date Detail:
Created Date:  2006-05-31     Completed Date:  2006-07-18     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  0417360     Medline TA:  Transfusion     Country:  United States    
Other Details:
Languages:  eng     Pagination:  919-33     Citation Subset:  IM    
Affiliation:
Department of Anesthesiology, Emory University Hospital, Atlanta, Georgia, USA.
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MeSH Terms
Descriptor/Qualifier:
Anticoagulants / adverse effects*
Blood Coagulation Disorders / drug therapy*,  etiology
Clinical Trials as Topic
Factor VII / adverse effects,  therapeutic use*
Factor VIIa
Fibrosis / blood,  complications*
Humans
Recombinant Proteins / adverse effects,  therapeutic use
Retrospective Studies
Thrombosis / etiology
Wounds and Injuries / blood,  complications*
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Recombinant Proteins; 0/recombinant FVIIa; 9001-25-6/Factor VII; EC 3.4.21.21/Factor VIIa

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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