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Results from a pre-specified pooled analysis of the RECORD clinical trial program confirmed that the novel oral anticoagulant Xarelto (rivaroxaban), taken as one tablet, once-daily, was superior to enoxaparin-based treatment regimens for the prevention of venous thromboembolism (VTE) after total knee or hip replacement surgery by more than 50%, with low rates of major bleeding that were not statistically different from the comparator.
Pooled results from the four RECORD trials, involving more than 12,500 patients, were presented at the 50th annual meeting of the American Society of Hematology (ASH) in San Francisco, USA.
RECORD is the largest clinical trial program ever conducted of an oral anticoagulant in the prevention of VTE after such surgeries.
“Swelling in the leg and shortness of breath are symptoms that can herald venous thromboembolism, which, in turn, can result in long-term complications or death,” said Dr. A.G.G. Turpie, Professor of Medicine, McMaster University, Canada, and Principal Investigator for the RECORD program. “As a physician, one of my goals is to reduce patients’ risk of complications, and these data show that Xarelto has the ability to reduce the composite of symptomatic VTE and all cause mortality by half when compared to enoxaparin.”
These findings confirm the results of the four individual RECORD studies, which demonstrated the superior efficacy of rivaroxaban for preventing total VTE both in head-to-head comparisons with enoxaparin, as well as when comparing extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin.
RECORD4 study demonstrates Xarelto is the only oral anticoagulant to show clinical benefit in head-to-head comparison against US approved regimen of enoxaparin.