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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Format: | Article |
Language: | English |
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Dove Medical Press
2010-06-01
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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 |
first_indexed | 2024-12-18T04:16:29Z |
format | Article |
id | doaj.art-3b082c4261c84a7098f821ae9898af4f |
institution | Directory Open Access Journal |
issn | 1177-8881 |
language | English |
last_indexed | 2024-12-18T04:16:29Z |
publishDate | 2010-06-01 |
publisher | Dove Medical Press |
record_format | Article |
series | Drug Design, Development and Therapy |
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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