Xarelto (Rivaroxaban) as Effective as Standard of Care in Patients with Thrombosis and Pulmonary Embolism
Major bleeding reduced by 46% in phase III analysis (September 20)
A pooled analysis of the phase III EINSTEIN trial program has shown that Xarelto (rivaroxaban, Janssen) is as effective as the standard of care in reducing the risk of deep-vein thrombosis (DVT) and pulmonary embolism (PE) in people with symptomatic DVT or PE, while reducing the incidence of major bleeding by 46%.
The analysis also found that safety and efficacy outcomes for Xarelto were consistent across four subgroups of participants: fragile subjects, those with cancer, subjects with a history of recurrent venous thromboembolism (VTE), and those presenting with a large clot.
The new findings were published in the Thrombosis Journal.
This prespecified pooled analysis included results from the EINSTEIN-DVT and EINSTEIN-PE studies. The analysis included more than 8,000 participants, divided between the DVT (n = 3,449) and PE (n = 4,833) studies, which indicated that the treatment benefit of Xarelto can be expected for subjects with either condition. Results from the pooled analysis were presented at the 54th American Society of Hematology (ASH) Annual Meeting in Atlanta in December 2012.
Xarelto (rivaroxaban) is the most-prescribed oral anticoagulant in the U.S. and is approved for six clinical uses in this country.
Source: PR Newswire; September 20, 2013.