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Blood, 15 September 2008, Vol. 112, No. 6, pp. 2242-2247.
Prepublished online as a Blood First Edition Paper on July 11, 2008; DOI 10.1182/blood-2008-05-160143.
 Previous Article | Next Article 
Submitted May 28, 2008
Accepted June 25, 2008
A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor Rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis. The EINSTEIN-DVT Dose-Ranging Study
Harry R Buller*, Anthonie W.A. Lensing, Martin H Prins, Giancarlo Agnelli, Alexander Cohen, Alexander S Gallus, Frank Misselwitz, Gary Raskob, Sebastian Schellong, and Annelise Segers
Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands
Clinical Research Department, BayerHealthCare AG, Wuppertal, Germany
Department of Epidemiology, Care and Public Health Research Institute, University of Maastricht, Maastricht, Netherlands
Institute of Internal and Vascular Medicine, University of Perugia, Perugia, Italy
School of Medicine & Dentistry, Kings College, London, United Kingdom
Department of Hematology, Flinders Medical Center, Bedford Park, Australia
College of Public Health, University of Oklahoma HSC, Oklahoma City, United States
Universitaetsklinikum, Carl Gustav Carus, Dresden, Germany
Clinical Research, International Clinical Trial Organization and Management, Amsterdam, Netherlands
* Corresponding author; email: m.m.veendorp{at}amc.uva.nl.
We performed a randomized, dose-ranging study, double-blind for rivaroxaban doses and open-label for the comparator (low molecular weight heparin followed by vitamin K antagonists) to assess the optimal dose of rivaroxaban for the treatment of deep-vein thrombosis. A total of 543 patients with acute deep-venous thrombosis received rivaroxaban 20, 30 or 40 mg once-daily or comparator. Treatment duration lasted for 84 days. The primary efficacy outcome was the 3-month incidence of the composite of symptomatic venous thromboembolic complications and asymptomatic deterioration in thrombotic burden as assessed by comparison of ultrasound and perfusion lung scanning at day 84 with baseline. The main safety outcome was the composite of major and clinically relevant, non-major bleeding. A total of 449 (83%) of the 543 patients could be included in the per-protocol population. The primary efficacy outcome occurred in 6.1, 5.4 and 6.6% of the rivaroxaban 20, 30, and 40 mg treatment groups, respectively, and in 9.9% receiving standard therapy. The main safety outcome occurred in 5.9, 6.0, and 2.2% of the rivaroxaban 20, 30, and 40 mg treatment groups, respectively, and in 8.8% during standard therapy. These results with simple fixed-dose oral regimens justify phase III evaluations. Clinical Trials.gov Identifier NCT00395772
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