Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Oral rivaroxaban for the treatment of symptomatic pulmonary embolism
New England Journal of Medicine, Volume 366, No. 14, Year 2012
Notification
URL copied to clipboard!
Description
BACKGROUND: A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. This approach may also simplify the treatment of pulmonary embolism. METHODS: In a randomized, open-label, event-driven, noninferiority trial involving 4832 patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding. RESULTS: Rivaroxaban was noninferior to standard therapy (noninferiority margin, 2.0; P = 0.003) for the primary efficacy outcome, with 50 events in the rivaroxaban group (2.1%) versus 44 events in the standard-therapy group (1.8%) (hazard ratio, 1.12; 95% confidence interval [CI], 0.75 to 1.68). The principal safety outcome occurred in 10.3% of patients in the rivaroxaban group and 11.4% of those in the standardtherapy group (hazard ratio, 0.90; 95% CI, 0.76 to 1.07; P = 0.23). Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P = 0.003). Rates of other adverse events were similar in the two groups. CONCLUSIONS: A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile. (Funded by Bayer HealthCare and Janssen Pharmaceuticals; EINSTEIN-PE ClinicalTrials.gov number, NCT00439777.). Copyright © 2012 Massachusetts Medical Society.
Authors & Co-Authors
Büller, Harry R.
Netherlands, Amsterdam
Universiteit Van Amsterdam
Prins, Martin H.
Netherlands, Maastricht
Maastricht Universitair Medisch Centrum+
Lensing, Anthonie W.A.
Germany, Berlin
Bayer Pharma ag
Décousus, Hervè A.
France, Saint-etienne
Université Jean Monnet Saint Etienne
Jacobson, Barry Frank
South Africa, Johannesburg
Charlotte Maxeke Johannesburg Academic Hospital
Minar, Erich
Austria, Vienna
Medizinische Universität Wien
Chlumský, Jaromír
Czech Republic, Prague
Fakultní Nemocnice V Motole
Verhamme, Peter B.
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Wells, Philip Stephen
Canada, Ottawa
L'hôpital D'ottawa
Agnelli, Giancarlo
Italy, Perugia
Università Degli Studi Di Perugia
Cohen, Alexander Thomas
United Kingdom, London
King's College Hospital
Berkowitz, Scott D.
United States, Whippany
Bayer Corporation, Usa
Bounameaux, Henri Ruti
Switzerland, Geneva
Hôpitaux Universitaires de Genève
Davidson, Bruce L.
United States, Seattle
University of Washington School of Medicine
Misselwitz, Frank
Germany, Berlin
Bayer Pharma ag
Gallus, Alexander Stephen
Australia, Adelaide
Flinders University
Raskob, Gary E.
United States, Oklahoma City
University of Oklahoma Health Sciences Center
Schellong, Sebastian M.
Germany, Dresden
Krankenhaus Dresden-friedrichstadt
Segers, Annelise
Netherlands, Amsterdam
Academic Research Organization
Statistics
Citations: 1,700
Authors: 19
Affiliations: 18
Identifiers
Doi:
10.1056/NEJMoa1113572
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Environmental
Health System And Policy