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Effect of rFVIIa dose and time to treatment on patients with haemophilia and inhibitors: analysis of HemoRec registry data from the Czech Republic

Salaj, P.; Brabec, P.; Penka, M.; Pohlreichova, V.; Smejkal, P.; Cetkovsky, P.; Dusek, L. and Hedner, Ulla LU (2009) In Haemophilia 15(3). p.752-759
Abstract
Identifying haemophilia patients with inhibitors for clinical trials is difficult due to the limited number of patients available. Registries are therefore being established as an additional means of data collection. The aim of this study was to investigate the effect of different recombinant activated factor VII (rFVIIa; NovoSeven((R))) dose ranges and dosing schedules on the incidence of re-bleeding in haemophilia patients with inhibitors. In this retrospective, uncontrolled study, data on the bleeding patterns of adult haemophilia patients with high responding inhibitors were analysed. Only data from the Czech Republic, obtained by the HemoRec registry, were used. This study analysed 'real-life' clinical data and focused on the... (More)
Identifying haemophilia patients with inhibitors for clinical trials is difficult due to the limited number of patients available. Registries are therefore being established as an additional means of data collection. The aim of this study was to investigate the effect of different recombinant activated factor VII (rFVIIa; NovoSeven((R))) dose ranges and dosing schedules on the incidence of re-bleeding in haemophilia patients with inhibitors. In this retrospective, uncontrolled study, data on the bleeding patterns of adult haemophilia patients with high responding inhibitors were analysed. Only data from the Czech Republic, obtained by the HemoRec registry, were used. This study analysed 'real-life' clinical data and focused on the collection of the same parameters in different patients: time from bleeding onset to first injection, effect of first injection, number of re-bleedings, total number of injections and total amount of haemostatic drug used. Fifteen patients met the inclusion criteria and were included into the study (128 bleeding episodes). Patients treated within 2 h of bleeding onset experienced less re-bleeding than patients treated after 2 h of bleeding onset (5.2% vs. 13.7%, respectively). In addition, patients who were treated after 2 h of bleeding onset experienced fewer re-bleedings when high-dose rFVIIa was used (15.8% and 0%; < 120 mu g kg(-1) and > 250 mu g kg(-1), respectively). Initial high-dose rFVIIa was also associated with a decline in total rFVIIa consumption. This registry has provided a unique insight into the bleeding patterns of inhibitor patients, highlighting the importance of early treatment initiation and appropriate starting dose. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
registry, inhibitors, haemophilia, bleeding, dose, rFVIIa
in
Haemophilia
volume
15
issue
3
pages
752 - 759
publisher
Federation of European Neuroscience Societies and Blackwell Publishing Ltd
external identifiers
  • wos:000265409600014
  • scopus:65449145067
ISSN
1351-8216
DOI
10.1111/j.1365-2516.2009.02007.x
language
English
LU publication?
yes
id
483acc0d-ae5f-43cf-9383-1a234d441a60 (old id 1399532)
date added to LUP
2009-06-15 15:18:28
date last changed
2017-12-10 03:52:23
@article{483acc0d-ae5f-43cf-9383-1a234d441a60,
  abstract     = {Identifying haemophilia patients with inhibitors for clinical trials is difficult due to the limited number of patients available. Registries are therefore being established as an additional means of data collection. The aim of this study was to investigate the effect of different recombinant activated factor VII (rFVIIa; NovoSeven((R))) dose ranges and dosing schedules on the incidence of re-bleeding in haemophilia patients with inhibitors. In this retrospective, uncontrolled study, data on the bleeding patterns of adult haemophilia patients with high responding inhibitors were analysed. Only data from the Czech Republic, obtained by the HemoRec registry, were used. This study analysed 'real-life' clinical data and focused on the collection of the same parameters in different patients: time from bleeding onset to first injection, effect of first injection, number of re-bleedings, total number of injections and total amount of haemostatic drug used. Fifteen patients met the inclusion criteria and were included into the study (128 bleeding episodes). Patients treated within 2 h of bleeding onset experienced less re-bleeding than patients treated after 2 h of bleeding onset (5.2% vs. 13.7%, respectively). In addition, patients who were treated after 2 h of bleeding onset experienced fewer re-bleedings when high-dose rFVIIa was used (15.8% and 0%; &lt; 120 mu g kg(-1) and &gt; 250 mu g kg(-1), respectively). Initial high-dose rFVIIa was also associated with a decline in total rFVIIa consumption. This registry has provided a unique insight into the bleeding patterns of inhibitor patients, highlighting the importance of early treatment initiation and appropriate starting dose.},
  author       = {Salaj, P. and Brabec, P. and Penka, M. and Pohlreichova, V. and Smejkal, P. and Cetkovsky, P. and Dusek, L. and Hedner, Ulla},
  issn         = {1351-8216},
  keyword      = {registry,inhibitors,haemophilia,bleeding,dose,rFVIIa},
  language     = {eng},
  number       = {3},
  pages        = {752--759},
  publisher    = {Federation of European Neuroscience Societies and Blackwell Publishing Ltd},
  series       = {Haemophilia},
  title        = {Effect of rFVIIa dose and time to treatment on patients with haemophilia and inhibitors: analysis of HemoRec registry data from the Czech Republic},
  url          = {http://dx.doi.org/10.1111/j.1365-2516.2009.02007.x},
  volume       = {15},
  year         = {2009},
}