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Bayer's Novel Oral Anticoagulant Xarelto(R) (Rivaroxaban) Gets European Licence

May 29, 2017

Today the UK's 160,000 elective hip and knee replacement patients1 will be eligible to receive Bayer Schering Pharma's new oral anticoagulant, rivaroxaban. This follows European Commission authorisation of its licence for the prevention of venous thromboembolism (deep vein thrombosis (DVT) and pulmonary embolism (PE)), in patients undergoing elective hip or knee replacement surgery.

In its comprehensive RECORD clinical trial programme involving over 12,500 patients, rivaroxaban, a direct Factor Xa inhibitor, taken as a once-daily tablet, demonstrated improved efficacy of up to fifty percent over the existing standard of care: the injectable, low molecular weight heparin enoxaparin. 2-3 Rivaroxaban is the only oral anticoagulant to have demonstrated superior efficacy over enoxaparin, the mainstay of current thromboprophylaxis.2-4

Despite the presence of national guidelines, which recommend extended thromboprophylaxis for all high risk patients for up to four weeks following major orthopaedic surgery,5 the limitations of current commonly used treatment options and lack of mandatory patient risk assessment mean that many patients still do not receive satisfactory pharmaceutical thromboprophylaxis to prevent potentially fatal blood clots following surgery. At particularly high risk, due to the invasive nature of their procedure and lack of mobility it causes, are those undergoing major orthopaedic surgery. Without prophylactic treatment up to 50% of these patients would go on to develop a venous blood clot.6

Results of the RECORD 1 and 3 trials, which compared rivaroxaban with enoxaparin, demonstrated that prophylactic treatment with rivaroxaban was associated with a 70% relative risk reduction (RRR) in the development of venous blood clots in hip replacement patients (2.6% absolute risk reduction) and 49% RRR in knee replacement patients (9.2% absolute risk reduction), whilst demonstrating comparable bleeding and side effect profiles.2,3 With its efficacy advantages and convenient oral administration, which requires no coagulation monitoring, rivaroxaban has the potential to have a significant impact on clinical practice.

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 rivaroxaban provides exciting new opportunities to protect patients from potentially fatal blood clots."

Commenting on the approval of rivaroxaban, Beverley Hunt, Medical Director, Lifeblood The Thrombosis Charity, said: "Hospital-acquired DVT is the number one patient safety issue in UK hospitals. We at Lifeblood are committed to campaigning for mandatory assessment of the risk of hospital-acquired DVT in every adult patient admitted to a UK hospital. The availability of a new anticoagulant which has shown to be more efficacious than the current standard of care, and also makes extended thromboprophylaxis more accessible is an exciting step forward"

The extensive clinical trial programme supporting rivaroxaban makes it the most studied oral direct Factor Xa inhibitor in the world today.

About hospital-acquired DVT

-- Venous blood clots, (also known as venous thromboembolism or VTE) can take the form of either:

- A deep vein thrombosis (DVT) - a blood clot in a deep vein (usually in the leg) that partially or totally blocks the flow of blood7

- A pulmonary embolism (PE) - a blood clot blocking an artery in the lungs7

-- Each year an estimated 25,000 to 32,000 people in the UK die from venous blood clots as a result of a hospital stay or surgical procedure (sometimes referred to as 'hospital-acquired DVT'). This is more people than die from breast cancer, prostate cancer, HIV/AIDS and road traffic accidents combined8

-- Many of these deaths could be prevented8

-- Effective prevention and treatment of hospital-acquired DVT is a major national public health issue8

-- People at risk of hospital-acquired DVT include people undergoing major orthopaedic surgery and those who are hospitalised or immobilised over long periods9,10

-- The majority (74%) of hospital-acquired DVT cause symptoms after the patient has left hospital10

-- Hospital-acquired DVT occur in up to 50% of patients undergoing major orthopaedic surgery who do not receive preventative care6

-- In November 2007, the All Party Parliamentary Thrombosis Group (APPTG) published a report following an audit of acute hospital trusts which found that only 32% of hospital trusts are taking steps to risk assess patients (for hospital-acquired DVT) and bring their practices in line with NICE and government recommendations11 which are as follows:

-- Current NICE recommendations state that:5

- All patients undergoing major surgery should be assessed to identify their individual risk of developing VTE after the procedure

- All patients undergoing major orthopaedic surgery of the lower limbs should receive anticoagulant therapy, LMWH (low molecular weight heparin) for up to 28 days after surgery in combination with pressure stockings, to reduce the risk of VTE

About Xarelto (rivaroxaban)

Xarelto is the first of a new class of oral anticoagulant specifically inhibiting (blocking) Factor Xa, a pivotal step in the coagulation (blood clotting) process4

Unlike low weight molecular heparins such as enoxaparin, which are administered daily by injection, Xarelto is an oral, once-daily tablet which is given six to ten hours after surgery.2 It is licensed for two weeks following elective knee replacement surgery or five weeks following elective hip replacement surgery. An oral tablet such as Xarelto offers a more convenient, patient orientated treatment option than an injection as it enables patients to more easily continue their anticoagulant therapy at home, providing ongoing protection against the continued risk of developing clots. Further, there are no coagulation monitoring requirements with Xarelto, which is an advantage over traditional oral anticoagulants such as Warfarin.

Almost 50,000 people are expected to be enrolled into the overall development programme for Xarelto. Clinical trials are underway evaluating its use in a wide range of conditions.

About Bayer Schering Pharma UK

Bayer Schering Pharma is a leading, worldwide speciality pharmaceutical company. Its research and business activities are focussed on the fields of haematology & cardiology, oncology, diagnostic imaging, primary care, specialised therapeutics and women's healthcare. With innovative products and using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life of patients.



1. The National Joint Registry. (Last accessed 08.09.08)

2. Eriksson BI, Borris LC, Friedman RJ et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthoplasty. N Engl J Med 2008;358:-2765-75

3. Lassen MR, Ageno W, Borris LC et al. Rivaroxaban versus enoxaparin after total knee arthroplasty. N Engl J Med 2008; 358:2776 - 86

4. Turpie A et al. Comparison of rivaroxaban-an oral, direct factor Xa inhibitor-and subcutaneous enoxaparin for thromboprophylaxis after total knee

replacement (RECORD4: a phase 3 study). European Federation of National Associations of Orthopaedics and Traumatology 2008 Annual Meeting; May 29-June, 2008; Nice, France. Abstract F85.

5. NICE Clinical Guideline 46. Quick Reference Guide. Venous Thromboembolism: Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in inpatients undergoing surgery. April 2007

6. Choi BY et al. Venous Thromboembolism Following Total Knee Replacement. J Surg Orthop Adv 2007; 16: 31-5.

7. Lifeblood: The Thrombosis Charity. Ten questions about thrombosis. 2008. (Last accessed on 28.08.08)

8. The Commons Health Committee. 2005. The Prevention of Venous Thromboembolism in Hospitalised Patients.

9. Heit JA. The Epidemiology of Venous Thromboembolism in the Community: Implications for Prevention and Management.J Thromb Thrombolysis 2006; 21: 23-9.

10. Spencer FA et al. Venous Thromboembolism in the Outpatient Setting. Arch Intern Med 2007; 167: 1471-5.

Bayer Schering Pharma UK

View drug information on Warfarin Sodium tablets; Xarelto.