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news.Johnson & Johnson has reported that results from a Phase III trial showed that administration of the oral, once-daily, investigational anticoagulant rivaroxaban was statistically superior to once-daily subcutaneous administration of enoxaparin, the current standard of care in preventing venous thromboembolism in patients following hip replacement surgery.
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Data from the Record1 study show that rivaroxaban demonstrated a 70% relative risk reduction (RRR) in total venous thromboembolism (VTE) when compared with enoxaparin, and an 88% RRR in major VTE. Rivaroxaban demonstrated a similar rate of both major bleeding (0.3% and 0.1%, respectively) and non-major bleeding (5.8% and 5.8%) compared to enoxaparin.
The Record1 (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial evaluated the safety and efficacy of rivaroxaban with enoxaparin in patients undergoing total hip replacement surgery. The duration of thromboprophylaxis in both treatment groups was five weeks. The primary endpoint was total VTE (composite of deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality) and the main secondary endpoint was major VTE (composite of proximal deep vein thrombosis, non-fatal pulmonary embolism and VTE-related death).
Rivaroxaban is a novel, oral, once-daily direct Factor Xa inhibitor in advanced clinical development for a range of patients who could benefit from the prevention and/or treatment of blood clots. Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development and Bayer HealthCare.