ASH: Oral Venous Thrombosis Agent Effective and Safe

Rivaroxaban may provide a simple, fixed-dose approach for short-term and continued treatment

MONDAY, Dec. 6 (HealthDay News) -- Rivaroxaban, an oral factor Xa inhibitor, may provide clinical practitioners with a simple, fixed-dosed regimen for the short-term and continued treatment of deep-vein thrombosis (DVT), according to a study published online Dec. 4 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the American Society of Hematology, held from Dec. 4 to 7 in Orlando, Fla.

In an open-label, event-driven, noninferiority study, Rupert Bauersachs, M.D., of the Klinikum Darmstadt in Germany, and colleagues randomized 3,449 patients with acute, symptomatic DVT to oral rivaroxaban alone (15 mg twice daily for three weeks, followed by 20 mg once daily) or subcutaneous enoxaparin followed by a vitamin K antagonist (either warfarin or acenocoumarol) for three, six, or 12 months. In parallel, the investigators conducted a double-blind, event-driven superiority study and randomized patients who had completed six to 12 months of treatment for venous thromboembolism to rivaroxaban alone (20 mg once daily) or placebo for an additional six to 12 months.

With respect to the primary outcome -- recurrent venous thromboembolism -- the investigators found that rivaroxaban had noninferior efficacy compared with the enoxaparin-vitamin K antagonist group (hazard ratio, 0.68). Major bleeding or clinically relevant nonmajor bleeding occurred in 8.1 percent of patients in each group. In the continued-treatment study, patients receiving rivaroxaban experienced eight events and those who received placebo experienced 42 events (hazard ratio, 0.18). The difference in nonfatal major bleeding events between the two groups was not statistically significant.

"In conclusion, oral rivaroxaban, at a dose of 15 mg twice daily for the first three 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," the authors write.

The study was funded by Bayer Schering Pharma and Ortho-McNeil; several authors disclosed financial ties to these and other pharmaceutical companies.

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