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In the European Union Xarelto® is indicated for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. The active compound of Xarelto®, rivaroxaban, is being studied in a number of other indications.
The Press Resources page is designed to give you online access to timely and relevant information about Xarelto®. In this section you will find information and resources for journalists, including current and archived press releases as well as a collection of background information and images related to Xarelto®.
About Xarelto®
Xarelto® is indicated for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.1
Xarelto® belongs to a group of medicines called anticoagulants. It works by blocking the blood clotting Factor Xa and thereby reduces the tendency of the blood to form clots.1
Venous blood clots originate in the blood vessels that transport the blood back into the heart and from there to the lungs. Venous thromboembolism (VTE) can take the form of either a deep vein thrombosis (DVT), a blood clot in a deep vein (usually in the leg), or a pulmonary embolism (PE), a potentially life-threatening blood clot blocking a vessel in the lungs.14
Healthy patients undergoing elective major orthopaedic surgery, such as total knee or total hip replacement, are at risk of venous blood clots due to factors such as vascular damage and reduced mobility.43 Venous blood clots occur in 40-60% of patients undergoing orthopaedic surgery who do not receive preventive care.61, 65
Recent guidelines recommend the routine use of anticoagulants for patients undergoing elective hip or knee replacement surgery.6
Xarelto® belongs to a group of medicines called anticoagulants. It works by blocking the blood clotting Factor Xa and thereby reduces the tendency of the blood to form clots.1
Venous blood clots originate in the blood vessels that transport the blood back into the heart and from there to the lungs. Venous thromboembolism (VTE) can take the form of either a deep vein thrombosis (DVT), a blood clot in a deep vein (usually in the leg), or a pulmonary embolism (PE), a potentially life-threatening blood clot blocking a vessel in the lungs.14
- A deep vein thrombosis (DVT) is a blood clot in a deep vein (usually in the leg) that partially or totally blocks the flow of blood.
- A pulmonary embolism (PE) is a blood clot which breaks off and travels through the body, ultimately blocking a blood vessel in the lungs.
Healthy patients undergoing elective major orthopaedic surgery, such as total knee or total hip replacement, are at risk of venous blood clots due to factors such as vascular damage and reduced mobility.43 Venous blood clots occur in 40-60% of patients undergoing orthopaedic surgery who do not receive preventive care.61, 65
Recent guidelines recommend the routine use of anticoagulants for patients undergoing elective hip or knee replacement surgery.6
Fast Facts
- The extensive clinical trial programme for Xarelto® covering acute and chronic indications makes it the most studied oral, direct FLivingWithliverCancer/Japan/WORKAREA/htdocsactor Xa inhibitor in the world today. More than 65,000 patients are expected to be enrolled overall in the Xarelto® clinical development program.9, 68
- Venous blood clots kill more people in Europe each year than AIDS, breast cancer, prostate cancer, and road traffic accidents combined.46, 47
- VTE causes over 500,000 deaths in Europe every year.46
- An estimated 300,000 VTE-related deaths occur in the US each year.41
- Almost all the hospital deaths resulting from PE are preventable.59
Background information
- About Xarelto (7 Dec 2009)
- About EINSTEIN Studies (7 Dec 2009)
- Rivaroxaban Bibliography (7 Dec 2009)
- Rivaroxaban Clinical Study Programme (7 Dec 2009)
- About Venous Thromboembolism (VTE) (7 Dec 2009)
- Glossary of Terms (7 Dec 2009)
- About RECORD Studies (10 Nov 2008)
- The History of Anticoagulants (10 Nov 2008)
- Unterstanding Venous Blood Clots (10 Nov 2008)
- ATLAS Backgrounder (10 Nov 2008)
- Understanding Acute Coronary Syndrome (10 Nov 2008)
- 1 - Xarelto® (rivaroxaban) Summary of Product Characteristics as approved by the European Commission.
- 14 - Turpie AG, Chin BS, Lip GY. Venous thromboembolism: pathophysiology, clinical features, and prevention. BMJ. 2002;325(7369):887-890.
- 43 - Merli GJ. Pathophysiology of venous thrombosis, thrombophilia, and the diagnosis of deep vein thrombosis-pulmonary embolism in the elderly. Clin Geriatr Med. 2006;22(1):75-92.
- 61 - Geerts WH, Pineo GF, Heit JA, et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 suppl):338S-400S.
- 65 - White RH, Zhou H, Romano PS. Incidence of symptomatic venous thromboembolism after different elective or urgent surgical procedures. Thromb Haemost. 2003;90(3):446-455.
- 6 - Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 suppl):381S-453S.
- 9 - International Congress on Thrombosis: Rivaroxaban is first novel oral anticoagulant to significantly reduce the composite outcome of symptomatic VTE and death [press release]. Leverkusen, Germany: Bayer HealthCare AG; June 30, 2008.
- 68 - U.S. FDA Advisory Committee supports favorable benefit-risk profile of Bayer’s rivaroxaban [press release] Available at http://www.press.bayer.com/baynews/baynews.nsf/id/2A95822BEA3213E7C125757E0074EC47?Open
- 46 - Cohen AT, Agnelli G, Anderson FA, et al; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007;98(4):756-764.
- 47 - Fitzmaurice DA, Murray E. Thromboprophylaxis for adults in hospital. BMJ. 2007;334(7602):1017-1018.
- 41 - Heit JA. Venous thromboembolism: disease burden, outcomes and risk factors. J Thromb Haemost. 2005;3(8):1611-1617.
- 59 - House of Commons Health Committee. The prevention of venous thromboembolism in hospitalised patients. Available at http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/99/99.pdf
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Factor Xa
- Pivotal component of blood clotting cascade. Stimulates the production of thrombin, the enzyme in the coagulation cascade that promotes the formation of blood clots.
- Major orthopaedic surgery
- Major operations on the bones or joints including total hip or knee replacement surgery.
- Thrombosis
- Formation of a clot inside a blood vessel.
- Pulmonary embolism
- A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
Images
Xarelto in Factor Xa Molecule
Image shows one molecule of Xarelto blocking the active site of a Factor Xa protein (generated from X-ray crystallography).
www.xarelto.com
©2008, Bayer Schering Pharma AG
Propagation
Activated Factor X, functioning as part of the prothrombinase complex on the surface of activated platelets, converts large amounts of prothrombin to thrombin, in the “thrombin burst.”
Embolus formation
Fragments of thrombi can break free to form potentially life-threatening pulmonary emboli.
Pulmonary embolus
Whole lung in which pulmonary arteries are obstructed by fresh (red) thrombus (circles).
Pulmonary embolism
The pathway of a pulmonary embolism (PE) from the lower half of the body: inferior vena cava, to right atrium, to right ventricle, to the pulmonary artery. This eventually obstructs blood flow to the lung. Patients with deep vein thrombosis (DVT) are at risk of PE, a life-threatening event.
Major veins of the lower extremity
The most common type of VTE is deep vein thrombosis (DVT), which occurs in veins deep within the muscles of the leg and pelvis.
Press Releases
6th Dec 2009
Treatment of Venous Thromboembolism (VTE):
Phase III EINSTEIN-Extension Study of Bayer’s Rivaroxaban Shows Significant Benefit in the Prevention of Secondary Symptomatic VTE- Impressive 82% Relative Risk Reduction (RRR) in the Recurrence of Symptomatic VTE over Patients Treated with Placebo
- Positive Benefit-Risk profile for Rivaroxaban Confirmed
- First Phase III Data in the Chronic Setting to be Presented as a Late-Breaker at the Annual Meeting of the American Society of Hematology
- Ongoing Discussions with FDA on Complete Response Letter for VTE Prevention After Total Knee and Hip Replacement Surgery
2nd Dec 2009
Leading-edge research in science and medicine:
Bayer Team wins the “Deutscher Zukunftspreis” awarded by the German President- German Federal President Horst Köhler praises outstanding innovation achievement
- Development of the novel oral anticoagulant rivaroxaban commended
19th Nov 2009
Positive Results from Chronic Study with Bayer’s Rivaroxaban Will be Presented As a Late Breaker at ASH 2009
Positive Results from Chronic Study with Bayer’s Rivaroxaban Will be Presented As a Late Breaker at ASH 2009
22nd Sep 2009
Leading-edge medical research and development:
Bayer researchers nominated for the “Deutscher Zukunftspreis” awarded by the German Federal President- Development of the novel anticoagulant rivaroxaban commended
- Three research and development teams on shortlist
30th Aug 2009
Bayer Committed to Prevention of Arterial Thrombosis:
Bayer Completes Enrollment into Major Phase III Study with Rivaroxaban (ROCKET AF)- ROCKET AF study compares rivaroxaban to warfarin in the prevention of stroke and non-CNS systemic embolism in patients with Atrial Fibrillation
- Bayer Schering Pharma supports Thrombosis Research Institute’s launch of GARFIELD – a global patient Registry to evaluate ‘real life’ outcomes in the prevention of stroke in patients with Atrial Fib
- Fast Track designation for rivaroxaban development program in the secondary prevention of cardiovascular events in patients with Acute Coronary Syndrome recognizes high unmet medical need.
14th July 2009
New Drug Application for Rivaroxaban in the U.S.:
Update on Status of Rivaroxaban Complete Response Letter From U.S. FDA
28th May 2009
Venous Blood Clot Prevention after Hip or Knee Replacement Surgery:
U.S. FDA Issues Complete Response Letter for Rivaroxaban- No new clinical or non-clinical studies to be conducted as a pre-requisite for approval
19th Mar 2009
Venous Blood Clot Prevention after Hip or Knee Replacement Surgery:
U.S. FDA Advisory Committee supports favorable benefit-risk profile of Bayer’s rivaroxaban
08. Dec 2008
Venous Blood Clot Prevention after Knee or Hip Replacement Surgery:
Xarelto® Reduces Symptomatic VTE and Death Following Knee or Hip Replacement Surgery by More Than 50% Compared to Enoxaparin in Pooled Analysis of RECORD Clinical Trial Program- Pooled Analysis of RECORD1-4 Trials Confirms Significant Benefit in Clinical Outcomes for Patients Treated with Xarelto
- RECORD4 Study Demonstrates Xarelto is the Only Oral Anticoagulant to Show Clinical Benefit in Head-to-Head Comparison Against U.S.-Approved Regimen of Enoxaparin
10. Nov 2008
Secondary Prevention in Acute Coronary Syndrome (ACS):
Bayer’s Xarelto® Shows Encouraging Results in Patients with Acute Coronary Syndrome- Phase II Data Presented as Late-Breaker at American Heart Association Meeting
- Phase III Study to be Initiated in December 2008
01. Oct 2008
Venous Blood Clot Prevention after Elective Hip or Knee Replacement Surgery:
Bayer’s Novel Anticoagulant Xarelto® now also Approved in the EU- Bayer will start marketing the new oral, once-daily anticoagulant very soon
- First-in-class product to demonstrate superior efficacy to current standard of care
16 Sept 2008
Venous Blood Clot Prevention after Elective Total Knee and Hip Replacement Surgery:
Bayer’s Xarelto® Approved in Canada
31 Aug 2008
Secondary prevention in acute coronary syndrome (ACS):
Rivaroxaban Phase II Data in ACS to be Presented at AHA Congress in November 2008- First data presentation from large dose-finding trial involving about 3,500 patients
- Acceleration of clinical development in acute coronary syndrome planned
30 Jul 2008
Venous Blood Clot Prevention after Hip or Knee Replacement Surgery:
Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S.- Rivaroxaban is first oral anticoagulant to achieve superior efficacy over the twice-daily
- No evidence of safety issues attributable to rivaroxaban after long-term exposure
25 Jul 2008
Venous Blood Clot Prevention after Elective Hip or Knee Replacement Surgery:
Bayer’s Novel Anticoagulant Rivaroxaban Recommended for Approval in the EU- Final approval from the European Commission expected within the next few months
30 Jun 2008
Venous Blood Clot Prevention after Knee and Hip Replacement Surgery:
Rivaroxaban is First Novel Oral Anticoagulant to Significantly Reduce the Composite Outcome of Symptomatic VTE and Death- Rivaroxaban shows superior efficacy to enoxaparin for this clinical outcome with a
- Pre-specified analysis of pooled data from RECORD 1-3 studies involving nearly
26. Jun 2008
Venous Blood Clot Prevention after Total Hip and Knee Replacement Surgery:
New England Journal of Medicine Publishes Results from Two of the Landmark Phase III RECORD Studies with Rivaroxaban- Head-to-Head trials involving over 7000 patients after Major Orthopedic Surgery
- Rivaroxaban superior to Enoxaparin in Preventing Venous Blood Clots
- Bleeding rates were low and comparable between the treatment arms
25. Jun 2008
Venous Blood Clot Prevention after Hip Replacement Surgery:
The Lancet Publishes Results from the Landmark Phase III Rivaroxaban Study RECORD2- Trial involving over 2.500 patients after hip replacement surgery
- Five weeks of Rivaroxaban compared to two weeks enoxaparin
- Extended Rivaroxaban treatment regimen significantly more effective with comparable low bleeding rates
30. May 2008
Prevention of Thromboembolism after Knee Replacement Surgery:
Rivaroxaban One Tablet/Once-Daily Superior to Twice-Daily Injectable Enoxaparin in Preventing Venous Blood Clots after Total Knee Replacement Surgery in Pivotal Phase III Trial- Rivaroxaban is First Oral Anticoagulant to Achieve Superior Efficacy over the Twice- Daily Injection of Enoxaparin while Maintaining Low Major Bleeding Rates
- RECORD4 Confirms Results of RECORD1, 2 and 3
- U.S. Submission Planned for mid 2008
- Prof. Turpie: “Rivaroxaban has the potential to revolutionize the way we prevent the formation of dangerous blood clots”
10. Dec 2007
VTE Prevention After Major Orthopaedic Surgery:
Three Pivotal Phase III Trials Show Superior Efficacy of Rivaroxaban over Standard of Care with Enoxaparin- Consistent results across three RECORD trials involving nearly 10,000 patients
- Venous thromboembolism considered the most frequent and potentially fatal complication following major orthopaedic surgery
- No evidence of liver signal attributable to rivaroxaban has been seen
8. Dec 2007
VTE Prevention After Hip Replacement Surgery:
Pivotal Phase III Data Show Superior Efficacy of Rivaroxaban over Enoxaparin- Head-to-Head Study Demonstrates Similar and Low Rate of Bleeding for Both Drugs
9. Nov 2007
New Phase III Trial Results for Rivaroxaban to be Presented at the 49th Annual Meeting of the American Society of Hematology
- Endpoints Met for RECORD1 and RECORD2 Trials in Total Hip Replacement Surgery
31. Oct 2007
Prevention of Venous Thromboembolism after Major Orthopedic Surgery:
Bayer HealthCare Submits Rivaroxaban for European Approval- Data Package for Rivaroxaban Involves Nearly 10,000 Patients in Three Phase III Trials
