Effect of rFVIIa dose and time to treatment on patients with haemophilia and inhibitors: analysis of HemoRec registry data from the Czech Republic
(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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/1399532
- author
- Salaj, P. ; Brabec, P. ; Penka, M. ; Pohlreichova, V. ; Smejkal, P. ; Cetkovsky, P. ; Dusek, L. and Hedner, Ulla LU
- organization
- publishing date
- 2009
- 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
- Wiley-Blackwell
- external identifiers
-
- wos:000265409600014
- scopus:65449145067
- ISSN
- 1351-8216
- DOI
- 10.1111/j.1365-2516.2009.02007.x
- language
- English
- LU publication?
- yes
- additional info
- The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Emergency medicine/Medicine/Surgery (013240200)
- id
- 483acc0d-ae5f-43cf-9383-1a234d441a60 (old id 1399532)
- date added to LUP
- 2016-04-01 12:23:05
- date last changed
- 2022-07-22 19:47:32
@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%; < 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.}}, 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}}, keywords = {{registry; inhibitors; haemophilia; bleeding; dose; rFVIIa}}, language = {{eng}}, number = {{3}}, pages = {{752--759}}, publisher = {{Wiley-Blackwell}}, 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}}, doi = {{10.1111/j.1365-2516.2009.02007.x}}, volume = {{15}}, year = {{2009}}, }