Rivaroxaban found noninferior to enoxaparin in acutely ill

February 7, 2013
Rivaroxaban found noninferior to enoxaparin in acutely ill
In acutely ill hospitalized patients, standard-duration rivaroxaban has similar efficacy as enoxaparin in reducing the risk of venous thromboembolism, while extended-duration rivaroxaban has superior efficacy, according to a study published in the Feb. 7 issue of the New England Journal of Medicine.

(HealthDay)—In acutely ill hospitalized patients, standard-duration rivaroxaban has similar efficacy as enoxaparin in reducing the risk of venous thromboembolism, while extended-duration rivaroxaban has superior efficacy, according to a study published in the Feb. 7 issue of the New England Journal of Medicine.

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 requiring hospitalization to receive subcutaneous (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 (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 to pharmaceutical companies, including Bayer and Janssen.

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