New antithrombotic drugs and European approval processes

Considering dabigatran and non-valvular atrial fi brillation in a European population taking vitamin K antagonists (about 60% of patients with atrial fi brillation),5 it could be estimated that the reduction in relative risk (25%) with the use of dabigatran could have prevented 30 000 strokes since...

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Bibliographic Details
Published in:The Lancet (British edition) 2011-08, Vol.378 (9792), p.662-663
Main Authors: Marijon, Eloi, Fauchier, Laurent, Heuzey, Jean-Yves Le
Format: Article
Language:English
Subjects:
Anticoagulants
Anticoagulants - therapeutic use
Benzimidazoles - adverse effects
Benzimidazoles - therapeutic use
beta-Alanine - adverse effects
beta-Alanine - analogs & derivatives
beta-Alanine - therapeutic use
Dabigatran
Drug Approval
Drug therapy
Europe
FDA approval
Fibrinolytic Agents - adverse effects
Fibrinolytic Agents - therapeutic use
Humanities and Social Sciences
Humans
Internal Medicine
Morpholines - adverse effects
Morpholines - therapeutic use
Pyrazoles - adverse effects
Pyrazoles - therapeutic use
Pyridones - adverse effects
Pyridones - therapeutic use
Rivaroxaban
Thiophenes - adverse effects
Thiophenes - therapeutic use
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Summary:Considering dabigatran and non-valvular atrial fi brillation in a European population taking vitamin K antagonists (about 60% of patients with atrial fi brillation),5 it could be estimated that the reduction in relative risk (25%) with the use of dabigatran could have prevented 30 000 strokes since the results of the RE-LY study were presented.1 Moreover, we can put forward the hypothesis that about half the eligible patients who were not actually prescribed vitamin K antagonists might benefi t from this new therapy.
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(11)61327-5