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New advances in stroke prevention in atrial fibrillation: ximelagatran and direct thrombin inhibition

Olsson, Bertil LU (2004) In European Heart Journal Supplements 6(B). p.20-24
Abstract
Ximelagatran is the first oral agent in a new class of direct thrombin inhibitors and is under investigation for the prevention and treatment of a range of thromboembolic disorders. Atrial. fibrillation (AF) is associated with a markedly increased risk of stroke and, while study results have consistently demonstrated that anticoagulant therapy with warfarin reduces this risk, there are substantial unmet needs in the management of AF-associated thrombotic risk. In particular, warfarin has unpredictable activity leading to the risk of bleeding complications and the need for routine anticoagulant monitoring. Ximelagatran has a range of potential benefits over warfarin in the prevention of AF-associated stroke, including predictable... (More)
Ximelagatran is the first oral agent in a new class of direct thrombin inhibitors and is under investigation for the prevention and treatment of a range of thromboembolic disorders. Atrial. fibrillation (AF) is associated with a markedly increased risk of stroke and, while study results have consistently demonstrated that anticoagulant therapy with warfarin reduces this risk, there are substantial unmet needs in the management of AF-associated thrombotic risk. In particular, warfarin has unpredictable activity leading to the risk of bleeding complications and the need for routine anticoagulant monitoring. Ximelagatran has a range of potential benefits over warfarin in the prevention of AF-associated stroke, including predictable anticoagulant activity that is not affected by food and a tow potential for drug-drug interactions. Consequently, the risk of bleeding complications may be,reduced and there is a fixed-dose regimen with no requirement for routine anticoagulant monitoring. The SPORTIF (Stroke Prevention using an ORal Thrombin Inhibitor in atrial. Fibrillation) series of studies is investigating the extent to which these potential advantages translate into clinical benefits. SPORTIF III is a Phase III study of the efficacy and safety of ximelagatran compared with warfarin in the prevention of stroke in 3407 patients with AF. The results demonstrate that ximelagatran has effectiveness non-inferior to well-controlled warfarin in the prevention of stroke and is associated with a lower risk of bleeding complications. With its predictable anticoagulant effect and the enhanced convenience offered by a fixed-dose regimen and with no requirement for routine coagulation monitoring, these results indicate that ximelagatran promises clinical benefits over warfarin that could improve the management of stroke risk in patients with AF. (C) 2004 The European Society of Cardiology. Published by Elsevier Ltd. All rights reserved. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
ximetagatran, antagonists, oral vitamin K, stroke prevention, oral direct thrombin inhibitors, non-valvular atrial fibrillation, SPORTIF III
in
European Heart Journal Supplements
volume
6
issue
B
pages
20 - 24
publisher
Oxford University Press
external identifiers
  • wos:000220835500005
  • scopus:1942488996
ISSN
1520-765X
DOI
10.1016/j.ehjsup.2004.01.014
language
English
LU publication?
yes
id
7a5cb176-3dd6-4533-aa00-9996e245456b (old id 281661)
alternative location
http://eurheartjsupp.oxfordjournals.org/cgi/content/abstract/6/suppl_B/B20
date added to LUP
2007-10-29 11:18:03
date last changed
2017-07-30 04:29:34
@article{7a5cb176-3dd6-4533-aa00-9996e245456b,
  abstract     = {Ximelagatran is the first oral agent in a new class of direct thrombin inhibitors and is under investigation for the prevention and treatment of a range of thromboembolic disorders. Atrial. fibrillation (AF) is associated with a markedly increased risk of stroke and, while study results have consistently demonstrated that anticoagulant therapy with warfarin reduces this risk, there are substantial unmet needs in the management of AF-associated thrombotic risk. In particular, warfarin has unpredictable activity leading to the risk of bleeding complications and the need for routine anticoagulant monitoring. Ximelagatran has a range of potential benefits over warfarin in the prevention of AF-associated stroke, including predictable anticoagulant activity that is not affected by food and a tow potential for drug-drug interactions. Consequently, the risk of bleeding complications may be,reduced and there is a fixed-dose regimen with no requirement for routine anticoagulant monitoring. The SPORTIF (Stroke Prevention using an ORal Thrombin Inhibitor in atrial. Fibrillation) series of studies is investigating the extent to which these potential advantages translate into clinical benefits. SPORTIF III is a Phase III study of the efficacy and safety of ximelagatran compared with warfarin in the prevention of stroke in 3407 patients with AF. The results demonstrate that ximelagatran has effectiveness non-inferior to well-controlled warfarin in the prevention of stroke and is associated with a lower risk of bleeding complications. With its predictable anticoagulant effect and the enhanced convenience offered by a fixed-dose regimen and with no requirement for routine coagulation monitoring, these results indicate that ximelagatran promises clinical benefits over warfarin that could improve the management of stroke risk in patients with AF. (C) 2004 The European Society of Cardiology. Published by Elsevier Ltd. All rights reserved.},
  author       = {Olsson, Bertil},
  issn         = {1520-765X},
  keyword      = {ximetagatran,antagonists,oral vitamin K,stroke prevention,oral direct thrombin inhibitors,non-valvular atrial fibrillation,SPORTIF III},
  language     = {eng},
  number       = {B},
  pages        = {20--24},
  publisher    = {Oxford University Press},
  series       = {European Heart Journal Supplements},
  title        = {New advances in stroke prevention in atrial fibrillation: ximelagatran and direct thrombin inhibition},
  url          = {http://dx.doi.org/10.1016/j.ehjsup.2004.01.014},
  volume       = {6},
  year         = {2004},
}