Rivaroxaban, designed for the prevention of deep-vein thrombosis after surgery, was recommended for approval by the FDA earlier this year.
According to researchers reporting in The Lancet, composite outcome measures — comprising deep vein thrombosis, nonfatal pulmonary embolism and all-cause mortality — were 6.9 percent with rivaroxaban and 10.1 percent with enoxaparin. Major bleeding events were seen in 0.7 percent of patients taking rivaroxaban versus 0.3 percent in those taking enoxaparin.
Based on these findings, the manufacturers have filed a marketing application for rivaroxaban, according to the report.
Read MedPage Today’s report on the new rivaroxaban trials.
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