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Statements

Subject Item
n2:RIV%2F00843989%3A_____%2F13%3A00103183%21RIV14-MZ0-00843989
rdf:type
n16:Vysledek skos:Concept
dcterms: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 dose of 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% CI, 0.41 to 0.71). Acute coronary syndromes occurred in 13 patients in the dabigatran group (0.9%) and 3 patients in the warfarin group (0.2%) (P=0.02). In the placebo-control study, recurrent venous thromboembolism occurred in 3 of 681 patients in the dabigatran group (0.4%) and 37 of 662 patients in the placebo group (5.6%) (hazard ratio, 0.08; 95% CI, 0.02 to 0.25; P<0.001). Major bleeding occurred in 2 patients in the dabigatran group (0.3%) and 0 patients in the placebo group. Major or clinically relevant bleeding occurred in 36 patients in the dabigatran group (5.3%) and 12 patients in the placebo group (1.8%) (hazard ratio, 2.92; 95% CI, 1.52 to 5.60). Acute coronary syndromes occurred in 1 patient each in the dabigatran and placebo groups. CONCLUSIONS: Dabigatran was effective in the extended treatment of venous thromboembolism and carried a lower risk of major or clinically relevant bleeding than warfarin but a higher risk than placebo. (Funded by Boehringer Ingelheim; RE-... 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 dose of 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% CI, 0.41 to 0.71). Acute coronary syndromes occurred in 13 patients in the dabigatran group (0.9%) and 3 patients in the warfarin group (0.2%) (P=0.02). In the placebo-control study, recurrent venous thromboembolism occurred in 3 of 681 patients in the dabigatran group (0.4%) and 37 of 662 patients in the placebo group (5.6%) (hazard ratio, 0.08; 95% CI, 0.02 to 0.25; P<0.001). Major bleeding occurred in 2 patients in the dabigatran group (0.3%) and 0 patients in the placebo group. Major or clinically relevant bleeding occurred in 36 patients in the dabigatran group (5.3%) and 12 patients in the placebo group (1.8%) (hazard ratio, 2.92; 95% CI, 1.52 to 5.60). Acute coronary syndromes occurred in 1 patient each in the dabigatran and placebo groups. CONCLUSIONS: Dabigatran was effective in the extended treatment of venous thromboembolism and carried a lower risk of major or clinically relevant bleeding than warfarin but a higher risk than placebo. (Funded by Boehringer Ingelheim; RE-...
dcterms:title
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism Extended use of dabigatran, warfarin, or placebo in venous thromboembolism
skos:prefLabel
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism Extended use of dabigatran, warfarin, or placebo in venous thromboembolism
skos:notation
RIV/00843989:_____/13:00103183!RIV14-MZ0-00843989
n16:predkladatel
n17:ico%3A00843989
n4:aktivita
n13:N
n4:aktivity
N
n4:cisloPeriodika
n. 8
n4:dodaniDat
n11:2014
n4:domaciTvurceVysledku
n7:5761522
n4:druhVysledku
n14:J
n4:duvernostUdaju
n9:S
n4:entitaPredkladatele
n18:predkladatel
n4:idSjednocenehoVysledku
74376
n4:idVysledku
RIV/00843989:_____/13:00103183
n4:jazykVysledku
n15:eng
n4:klicovaSlova
oral anticoagulant therapy; molecular weight heparin; long term; unfractionated heparin; atrial fibrillation; pulmonary embolism; initial treatment; randomized trial; 1st episode; prevention
n4:klicoveSlovo
n6:long%20term n6:atrial%20fibrillation n6:molecular%20weight%20heparin n6:pulmonary%20embolism n6:initial%20treatment n6:oral%20anticoagulant%20therapy n6:1st%20episode n6:unfractionated%20heparin n6:randomized%20trial n6:prevention
n4:kodStatuVydavatele
US - Spojené státy americké
n4:kontrolniKodProRIV
[CD6B33AE30F7]
n4:nazevZdroje
New England Journal of Medicine
n4:obor
n12:FA
n4:pocetDomacichTvurcuVysledku
1
n4:pocetTvurcuVysledku
461
n4:rokUplatneniVysledku
n11:2013
n4:svazekPeriodika
368
n4:tvurceVysledku
Goldhaber, S.Z. Friedman, J. Kakkar, A. K. Kearon, C. Schellong, S. Baanstra, D. Eriksson, H. Schulman, S. Kvamme, A. M. Mismetti, P. Matoška, Petr
n4:wos
000315095800005
s:issn
0028-4793
s:numberOfPages
10
n8:doi
10.1056/NEJMoa1113697