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Oral anticoagulant demonstrates statistically significant results in latest phase III trial

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NICE — Results from a recent phase III clinical trial demonstrate that rivaroxaban (Johnson & Johnson/Bayer), an oral, once-daily, investigational anticoagulant medication, performed better than enoxaparin (Sanofi-Aventis) for preventing venous blood clots in patients who underwent total knee replacement surgery.

Data from the RECORD4 (Regulation of Coagulation in Major Orthopedic Surgery Reducing the Risk of Deep Venous Thrombosis and Pulmonary Embolism) clinical trial were presented at the 9th European Federation of National Associations of Orthopaedics and Traumatology Congress, here.

RECORD4 compared rivaroxaban to enoxaparin for the prevention of venous thromboembolism (VTE) following total knee replacement (TKR) surgery in 3,148 patients. Rivaroxaban (10 mg taken once daily) was orally administered 6-8 hours postsurgery. Enoxaparin (30 mg administered twice daily) was initiated by subcutaneous injection 12-24 hours postsurgery, according to the abstract.

RECORD4 data show that rivaroxaban provided TKR surgery patients a statistically significant 31% relative risk reduction in total events - defined in the study as the composite of all DVT, nonfatal pulmonary embolism and all-cause mortality - compared to enoxaparin, said principal investigator A.G.G. Turpie, MD, of Hamilton, Ontario.

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), he said.

Major VTE and symptomatic VTE occurred less frequently with rivaroxaban, but the differences did not reach statistical significance.

RECORD4 is part of the RECORD program, which involved more than 12,500 total hip or knee replacement surgery patients, and is the first RECORD trial to evaluate rivaroxaban against enoxaparin 30 mg twice-daily, which is the FDA-approved dosing regimen for enoxaparin in knee replacement surgery, according to a Johnson & Johnson press release. The RECORD1, 2 and 3 studies compared rivaroxaban against enoxaparin dosed once daily at 40 mg.

"The superior efficacy and similar adverse event profile of rivaroxaban demonstrated in RECORD4 are in line with the outstanding results of the earlier RECORD studies," Turpie said in the press release. "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."

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 of 2008.

For more information:

• Turpie A, Bauer K, Davidson B, et al. Comparison of rivaroxaban – an oral, direct factor Xa inhibitor – and subcutaneous enoxaparin for thromboprophylaxis after total knee replacement (RECORD4: a phase III study). Paper F85. Presented at the 9th European Federation of National Associations of Orthopaedics and Traumatology Congress. May 29-June 1, 2008. Nice.