Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders

Pär I Johansson, Sisse R OstrowskiCapital Region Blood Bank, Section for Transfusion Medicine, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkBackground: Recombinant activated factor VII (rFVIIa, NovoSeven®) was introduced in 1996 for the treatment of hemophili...

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Main Authors: Pär I Johansson, Sisse R Ostrowski
Format: Article
Language:English
Published: Dove Medical Press 2010-06-01
Series:Drug Design, Development and Therapy
Online Access:http://www.dovepress.com/evidence-supporting-the-use-of-recombinant-activated-factor-vii-in-con-a4697
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author Pär I Johansson
Sisse R Ostrowski
author_facet Pär I Johansson
Sisse R Ostrowski
author_sort Pär I Johansson
collection DOAJ
description Pär I Johansson, Sisse R OstrowskiCapital Region Blood Bank, Section for Transfusion Medicine, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkBackground: Recombinant activated factor VII (rFVIIa, NovoSeven®) was introduced in 1996 for the treatment of hemophilic patients with antibodies against coagulation factor VIII or IX.Objective: To review the evidence supporting the use of rFVIIa for the treatment of patients with congenital bleeding disorders.Patients and methods: English-language databases were searched in September 2009 for reports of randomized controlled trials (RCTs) evaluating the ability of rFVIIa to restore hemostasis in patients with congenital bleeding disorders.Results: Eight RCTs involving 256 hemophilic patients with antibodies against coagulation factors, also known as inhibitors, were identified. The evidence supporting the use of rFVIIa in these patients was weak with regard to dose, clinical setting, mode of administration, efficacy, and adverse events, given the limited sample size of each RCT and the heterogeneity of the studies.Conclusion: The authors suggest that rFVIIa therapy in hemophilic patients with inhibitors should be based on the individual’s ability to generate thrombin and form a clot, and not on the patient’s weight alone. Therefore, assays for thrombin generation, such as whole-blood thromboelastography, have the potential to significantly improve the treatment of these patients.Keywords: hemophilia, inhibitors, coagulation factor VIII, coagulation factor IX, rFVIIa, NovoSeven, FEIBA, hemostasis, RCT
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spelling doaj.art-3b082c4261c84a7098f821ae9898af4f2022-12-21T21:21:21ZengDove Medical PressDrug Design, Development and Therapy1177-88812010-06-012010default107116Evidence supporting the use of recombinant activated factor VII in congenital bleeding disordersPär I JohanssonSisse R OstrowskiPär I Johansson, Sisse R OstrowskiCapital Region Blood Bank, Section for Transfusion Medicine, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkBackground: Recombinant activated factor VII (rFVIIa, NovoSeven®) was introduced in 1996 for the treatment of hemophilic patients with antibodies against coagulation factor VIII or IX.Objective: To review the evidence supporting the use of rFVIIa for the treatment of patients with congenital bleeding disorders.Patients and methods: English-language databases were searched in September 2009 for reports of randomized controlled trials (RCTs) evaluating the ability of rFVIIa to restore hemostasis in patients with congenital bleeding disorders.Results: Eight RCTs involving 256 hemophilic patients with antibodies against coagulation factors, also known as inhibitors, were identified. The evidence supporting the use of rFVIIa in these patients was weak with regard to dose, clinical setting, mode of administration, efficacy, and adverse events, given the limited sample size of each RCT and the heterogeneity of the studies.Conclusion: The authors suggest that rFVIIa therapy in hemophilic patients with inhibitors should be based on the individual’s ability to generate thrombin and form a clot, and not on the patient’s weight alone. Therefore, assays for thrombin generation, such as whole-blood thromboelastography, have the potential to significantly improve the treatment of these patients.Keywords: hemophilia, inhibitors, coagulation factor VIII, coagulation factor IX, rFVIIa, NovoSeven, FEIBA, hemostasis, RCThttp://www.dovepress.com/evidence-supporting-the-use-of-recombinant-activated-factor-vii-in-con-a4697
spellingShingle Pär I Johansson
Sisse R Ostrowski
Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders
Drug Design, Development and Therapy
title Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders
title_full Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders
title_fullStr Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders
title_full_unstemmed Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders
title_short Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders
title_sort evidence supporting the use of recombinant activated factor vii in congenital bleeding disorders
url http://www.dovepress.com/evidence-supporting-the-use-of-recombinant-activated-factor-vii-in-con-a4697
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