Rivaroxaban beats Lovenox: RECORD4 trial

Results from a pivotal Phase III trial presented at the annual meeting of the European Federation of National Associations of Orthopedics & Traumatology, in Nice, France, demonstrate that rivaroxaban, an oral, once-daily, investigational anticoagulant medication, was superior to enoxaparin in preventing venous blood clots in patients who underwent total knee replacement surgery.

The head-to-head study compared the agent with the US-approved dosing regimen for Sanofi-Aventis' Lovenox (enoxaparin), the current standard-of-care. Rivaroxaban is being jointly developed by US health care major Johnson & Johnson and Germany's Bayer HealthCare.

The RECORD4 data show that rivaroxaban (10mg once-daily) provided TKR surgery patients a statistically-significant 31% relative risk reduction in total venous thromboembolism 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 greater in rivaroxaban-treated patients. This difference was not statistically significant from the rate of major bleeding in enoxaparin-treated patients (p=0.110).