Bayer's new oral anticoagulant Xarelto (Rivaroxaban) gets European licence

Oct 2 2008

A new drug launched today could help in the fight against what experts and campaigners are calling a 'major patient safety issue' - the prevention of hospital-acquired DVT (deep vein thrombosis).

Xarelto, a once-daily tablet which has been shown to be significantly more effective than the existing standard treatment, injectable enoxaparin-, could help prevent unnecessary deaths from hospital-acquired DVT in patients undergoing elective hip or knee replacement surgery - one of the groups at highest risk.

In the UK 160,000 hip and knee replacement procedures are performed annually. Due to the invasive nature of this surgery and lack of mobility it causes, up to half of these patients would go on to develop a hospital-acquired DVT if preventative treatment (thromboprophylaxis) is not given. However, despite continued calls for more priority to be given to hospital-acquired DVT and for government investment in its prevention to reflect that of hospital-acquired infections (GBP50 million annually), the limitations of commonly used treatments and lack of compulsory patient risk assessment mean that many patients are still being put at risk by not receiving preventative treatment.

In clinical trials, such preventative treatment with new drug Xarelto has shown that patients undergoing elective hip or knee replacement surgery have a significantly lower risk of developing blood clots following their procedure than patients treated with the current mainstay of therapy, enoxaparin (70% and 49% relative risk reductions and 2.6% and 9.2% absolute risk reductions respectively)*, whilst maintaining comparable rates of bleeding.-

Beverley Hunt, Medical Director of Lifeblood: The Thrombosis Charity, comments

"Despite the clear evidence of benefit and the existence of national guidelines, current provision of thromboprophylaxis for hospitalised patients is suboptimal, and hospital-acquired DVTs continue to cause unnecessary suffering and death. As a health professional and campaigner for improved patient care, I hope the introduction of new, effective and convenient anticoagulants such as Xarelto will mean more patients, especially those in high risk groups, will benefit in the future."

The cost to the NHS of treating patients who develop hospital-acquired DVT from all causes is thought to be as high as GBP222.8 million per year, much higher than the cost of treating MRSA (GBP45 million). A further GBP19 million of the NHS' money is spent on litigation from patients and their families who have developed blood clots as a result of a hospital stay or procedure.(8) Despite this evidence suggests that hospital trusts are still failing to implement NICE's recommendations for preventative treatment to be provided to all high risk patients for up to four weeks following surgery.

Professor Ajay Kakkar, Professor of Surgical Sciences, Barts and the London School of Medicine and Dentistry, and Director Thrombosis Research Institute London UK commented "Thrombosis remains a major clinical challenge and today's announcement of the availability of Xarelto provides exciting new opportunities to protect patients from potentially fatal blood clots."

Xarelto is currently undergoing appraisal by NICE, which is expected to publish its recommendations in June 2009.