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Rivaroxaban may offer safe, effective treatment of venous thrombosis
Bauersachs R. N Engl J Med. 2010;363:2499-2510.
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Researchers have reported that rivaroxaban may provide a single-drug approach to the short-term and continued treatment of venous thrombosis and may improve the benefit-to-risk profile of anticoagulation.
The Acute DVT trial, one of three randomized trials of the EINSTEIN program, was an open-label, event-driven, noninferiority study comparing oral rivaroxaban (Xarelto, Bayer; n=1,731) with enoxaparin plus a vitamin K antagonist (n=1,718) for 3, 6 or 12 months in patients with acute, symptomatic deep vein thrombosis. Researchers also carried out a continued treatment trial, which was a randomized, double blind, event-driven superiority study comparing rivaroxaban alone (n=602) with placebo (n=594) for an additional 6 or 12 months in patients who had completed 6 to 12 months of treatment for venous thromboembolism.
Results from the Acute DVT trial indicated noninferiority efficacy for rivaroxaban regarding the primary efficacy outcome of recurrent venous thromboembolism (2.1% vs. 3%; HR=0.68; 95% CI, 0.44-1.04). The principal safety outcome of major bleeding or clinically relevant nonmajor bleeding occurred in 8.1% of the patients in both groups.
According to data from the continued-treatment trial, rivaroxaban had a superior event rate of recurrent venous thromboembolism compared with placebo (1.3% vs. 7.1%; HR=0.18; 95% CI, 0.09-0.39).
This led researchers to conclude that “oral rivaroxaban, at a dose of 15 mg twice daily for the first 3 weeks, followed by 20 mg once daily thereafter, without the need for laboratory monitoring, may provide an effective, safe, single-drug approach to the initial and continued treatment of venous thrombosis.”
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