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news.Johnson & Johnson Pharmaceutical R&D has reported positive results from a pivotal Phase III clinical trial which demonstrate that rivaroxaban, an oral, once-daily, investigational anticoagulant medication, was superior in preventing venous blood clots in patients who underwent total knee replacement surgery.
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The head-to-head study compared rivaroxaban with the US-approved dosing regimen for enoxaparin, the current standard of care, for the prevention of venous thromboembolism (VTE) following total knee replacement (TKR) surgery in 3,148 patients. Rivaroxaban (10mg once-daily) was orally administered six-eight hours post surgery, compared to enoxaparin (30mg twice-daily), which was initiated by subcutaneous injection 12-24 hours post surgery.
The Record4 data show that rivaroxaban (10mg once-daily) provided TKR surgery patients a statistically significant 31% relative risk reduction (RRR) in total VTE events – defined in the study as the composite of all deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality – compared to enoxaparin (30mg twice-daily) (6.9% and 10.1%, respectively, p=0.012).
Rates of major bleeding, the main safety endpoint, were low in both treatment groups, yet numerically greater in rivaroxaban-treated patients. This difference was not statistically significant from the rate of major bleeding in enoxaparin-treated patients (0.7% and 0.3% respectively; p=0.110).
Record4 is the third of three, direct, head-to-head comparisons within the Record program to demonstrate the superior efficacy of rivaroxaban over enoxaparin with a similar adverse event profile. The full Record data set will be used to support the new drug application for rivaroxaban to the FDA, which is planned for submission in the third quarter 2008.
AGG Turpie, principal investigator for the Record program, said: “The success of this trial strengthens my belief that direct Factor Xa inhibition with rivaroxaban has the potential to revolutionize the way we prevent the formation of dangerous blood clots.”