Extended use of dabigatran, warfarin, or placebo in venous thromboembolism

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F13%3A00103183" target="_blank" >RIV/00843989:_____/13:00103183 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1056/NEJMoa1113697" target="_blank" >http://dx.doi.org/10.1056/NEJMoa1113697</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1056/NEJMoa1113697" target="_blank" >10.1056/NEJMoa1113697</a>

Result language
angličtina
Original language name
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism
Original language description
BACKGROUND: Dabigatran, which is administered in a fixed dose and does not require laboratory monitoring, may be suitable for extended treatment of venous thromboembolism. METHODS: In two double-blind, randomized trials, we compared dabigatran at a doseof 150 mg twice daily with warfarin (active-control study) or with placebo (placebo-control study) in patients with venous thromboembolism who had completed at least 3 initial months of therapy. RESULTS: In the active-control study, recurrent venous thromboembolism occurred in 26 of 1430 patients in the dabigatran group (1.8%) and 18 of 1426 patients in the warfarin group (1.3%) (hazard ratio with dabigatran, 1.44; 95% confidence interval [CI], 0.78 to 2.64; P=0.01 for noninferiority). Major bleeding occurred in 13 patients in the dabigatran group (0.9%) and 25 patients in the warfarin group (1.8%) (hazard ratio, 0.52; 95% CI, 0.27 to 1.02). Major or clinically relevant bleeding was less frequent with dabigatran (hazard ratio, 0.54; 95%
Czech name
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Czech description
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Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FA - Cardiovascular diseases including cardio-surgery
OECD FORD branch
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Publication year
2013
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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