Rivaroxaban found noninferior to enoxaparin in acutely ill

Alexander T. Cohen, M.D., from King's College Hospital in London, and colleagues randomly assigned 8,101 patients (40 years of age and older) with reduced mobility and an acute medical illness requiring hospitalization to receive subcutaneous enoxaparin (40 mg once daily) for 10 days and oral placebo for 35 days, or subcutaneous placebo for 10 days and oral rivaroxaban (10 mg once daily) for 35 days.

At day 10, the researchers found that 2.7 percent of the rivaroxaban group and 2.7 percent of the enoxaparin group experienced asymptomatic proximal or symptomatic venous thromboembolism (relative risk, 0.97; P = 0.003 for non-inferiority). At day 35, 4.4 percent of the rivaroxaban group and 5.7 percent of the enoxaparin group experienced this outcome (relative risk, 0.77; P = 0.02). Major or clinically relevant non-major bleeding occurred in a significantly greater percentage of the rivaroxaban group both at day 10 (2.8 versus 1.2 percent) and at day 35 (4.1 versus 1.7 percent).

"The efficacy of standard-duration rivaroxaban was similar to that of enoxaparin, whereas the efficacy of extended-duration rivaroxaban was superior to that of enoxaparin," Cohen and colleagues conclude. "However, rivaroxaban was associated with an increased risk of clinically relevant bleeding."

The study was funded by Bayer, manufacturer of rivaroxaban, and Janssen, marketer of rivaroxaban; several authors disclosed financial ties to pharmaceutical companies, including Bayer and Janssen.

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Journal reference: New England Journal of Medicine

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