Bayer reports ‘superiority’ or rivaroxaban over enoxaparin

Bayer has announced late-breaking phase III clinical trial results showing the enhanced efficacy of Xarelto (rivaroxaban) as a preventative treatment for venous thromboembolism when compared to administration with enoxaparin in patients undergoing knee replacement surgery.

Presenting these results at the annual congress of the International Society on Thrombosis and Haemostasis, the company reported that patients receiving rivaroxaban had a 49 per cent relative risk reduction in the primary endpoint of the trial compared to those treated with enoxaparin.

The composite primary endpoint of the trial was deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality.

Furthermore, rivaroxaban exhibited a 62 per cent reduction in the secondary endpoint of developing major venous thromboembolism.

Dr Kemal Malik, head of global development at Bayer, said: “Based on the data we have generated, rivaroxaban shows great promise that it could set a new standard of care in thromboembolic disease as a new benchmark for balancing safety and efficacy in anticoagulation.”

He added that the company hoped that ongoing clinical trials will show the safety and efficacy of the compound while displaying its potential for use in both hospitals and the home without the need for patient monitoring.

In September 2006, following the publication phase II clinical trials of rivaroxaban, Bayer claimed the drug has the potential to provide a safer and more predictable anticoagulation therapy than that currently available.