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Statements

Subject Item
n2:RIV%2F00843989%3A_____%2F13%3AE0103854%21RIV14-MZ0-00843989
rdf:type
n7:Vysledek skos:Concept
dcterms:description
Background:Whether the oral factor Xa inhibitor edoxaban can be an alternative to warfarin in patients with venous thromboembolism is unclear. Methods:In a randomized, double-blind, noninferiority study, we randomly assigned patients with acute venous thromboembolism, who had initially received heparin, to receive edoxaban at a dose of 60 mg once daily, or 30 mg once daily (e.g., in the case of patients with creatinine clearance of 30 to 50 ml per minute or a body weight below 60 kg), or to receive warfarin. Patients received the study drug for 3 to 12 months. The primary efficacy outcome was recurrent symptomatic venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding.Results:A total of 4921 patients presented with deep-vein thrombosis, and 3319 with a pulmonary embolism. Among patients receiving warfarin, the time in the therapeutic range was 63.5%. Edoxaban was noninferior to warfarin with respect to the primary efficacy outcome, which occurred in 130 patients in the edoxaban group (3.2%) and 146 patients in the warfarin group (3.5%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.70 to 1.13; P<0.001 for noninferiority). The safety outcome occurred in 349 patients (8.5%) in the edoxaban group and 423 patients (10.3%) in the warfarin group (hazard ratio, 0.81; 95% CI, 0.71 to 0.94; P=0.004 for superiority). The rates of other adverse events were similar in the two groups. A total of 938 patients with pulmonary embolism had right ventricular dysfunction, as assessed by measurement of N-terminal pro-brain natriuretic peptide levels; the rate of recurrent venous thromboembolism in this subgroup was 3.3% in the edoxaban group and 6.2% in the warfarin group (hazard ratio, 0.52; 95% CI, 0.28 to 0.98). Conclusions:Edoxaban administered once daily after initial treatment with heparin was noninferior to high-quality standard therapy and caused significantly less bleeding in a broad spectrum of patients with venous thr... Background:Whether the oral factor Xa inhibitor edoxaban can be an alternative to warfarin in patients with venous thromboembolism is unclear. Methods:In a randomized, double-blind, noninferiority study, we randomly assigned patients with acute venous thromboembolism, who had initially received heparin, to receive edoxaban at a dose of 60 mg once daily, or 30 mg once daily (e.g., in the case of patients with creatinine clearance of 30 to 50 ml per minute or a body weight below 60 kg), or to receive warfarin. Patients received the study drug for 3 to 12 months. The primary efficacy outcome was recurrent symptomatic venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding.Results:A total of 4921 patients presented with deep-vein thrombosis, and 3319 with a pulmonary embolism. Among patients receiving warfarin, the time in the therapeutic range was 63.5%. Edoxaban was noninferior to warfarin with respect to the primary efficacy outcome, which occurred in 130 patients in the edoxaban group (3.2%) and 146 patients in the warfarin group (3.5%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.70 to 1.13; P<0.001 for noninferiority). The safety outcome occurred in 349 patients (8.5%) in the edoxaban group and 423 patients (10.3%) in the warfarin group (hazard ratio, 0.81; 95% CI, 0.71 to 0.94; P=0.004 for superiority). The rates of other adverse events were similar in the two groups. A total of 938 patients with pulmonary embolism had right ventricular dysfunction, as assessed by measurement of N-terminal pro-brain natriuretic peptide levels; the rate of recurrent venous thromboembolism in this subgroup was 3.3% in the edoxaban group and 6.2% in the warfarin group (hazard ratio, 0.52; 95% CI, 0.28 to 0.98). Conclusions:Edoxaban administered once daily after initial treatment with heparin was noninferior to high-quality standard therapy and caused significantly less bleeding in a broad spectrum of patients with venous thr...
dcterms:title
Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism
skos:prefLabel
Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism
skos:notation
RIV/00843989:_____/13:E0103854!RIV14-MZ0-00843989
n7:predkladatel
n13:ico%3A00843989
n3:aktivita
n16:N
n3:aktivity
N
n3:cisloPeriodika
n. 15
n3:dodaniDat
n12:2014
n3:domaciTvurceVysledku
n15:5761522
n3:druhVysledku
n18:J
n3:duvernostUdaju
n14:S
n3:entitaPredkladatele
n17:predkladatel
n3:idSjednocenehoVysledku
71227
n3:idVysledku
RIV/00843989:_____/13:E0103854
n3:jazykVysledku
n9:eng
n3:klicovaSlova
acute pulmonary embolism; factor XA inhibitor; atrial fibrillation; stroke prevention; clinical trials; epidemiology; angiography
n3:klicoveSlovo
n4:clinical%20trials n4:atrial%20fibrillation n4:angiography n4:stroke%20prevention n4:epidemiology n4:factor%20XA%20inhibitor n4:acute%20pulmonary%20embolism
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[04F26DF82441]
n3:nazevZdroje
New England Journal of Medicine
n3:obor
n5:FA
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
680
n3:rokUplatneniVysledku
n12:2013
n3:svazekPeriodika
369
n3:tvurceVysledku
Shi, M. Segers, A. Büller, H. R. Raskob, G. E. Grosso, M. A. Mercuri, M. Middeldorp, S. Prins, M. H. Matoška, Petr Schwocho, L. Décousus, H. Wells, P. Verhamme, P. Schellong, S.
n3:wos
000325431500008
s:issn
0028-4793
s:numberOfPages
10
n11:doi
10.1056/NEJMoa1306638