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Siste oppdatering 08 april 2016
L.NO.MKT.03.2016.1478

Xarelto® - Excellent Efficacy and Convenience with Reassuring Safety

Xarelto® directly inhibits Factor Xa

Xarelto® is the first direct inhibitor of Factor Xa available for clinical use. It is leading a new generation of Factor Xa–inhibiting drugs designed to meet a pressing clinical need for improved antithrombotic therapy. It is approved in Europe for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.1, 26
In patients undergoing these orthopaedic procedures, Xarelto® is given as one tablet once daily. This dosing routine is simple and convenient for patients and physicians, allowing patients to easily continue therapy from hospital to home without the need for bridging.1, 29
In RECORD1, 3, and 4 (studying prevention of VTE in patients undergoing elective hip or knee replacement surgery), Xarelto® demonstrated a significantly better efficacy, with similar safety, compared to enoxaparin.2, 4, 9 In RECORD2 comparing 5 weeks of Xarelto® with 2 weeks of enoxaparin, Xarelto® also demonstrated significantly better efficacy, with similar safety, compared to enoxaparin.3

Other available therapies

In addition to Xarelto®, there are other approaches available for prevention of VTE in patients undergoing major orthopaedic surgery. However, there are limitations associated with each of these therapeutic options, which may have led to underuse.7, 27
Unfractionated heparin (UFH) and low-molecular-weight heparins (LMWHs) and fondaparinux are available only in injectable forms, which make them inconvenient to use outside the hospital setting.8, 27
Fondaparinux is an indirect inhibitor of Factor Xa. It must be administered by subcutaneous injection.8 It does not inhibit prothrombin-bound or clot-associated Factor Xa.
Warfarin is administered orally and has a narrow therapeutic window, requiring strict monitoring of anticoagulation. Its anticoagulant effects are significantly modified by interactions with foods and other drugs. The risk of suboptimal treatment with warfarin is therefore high,30 which can result in significant problems, such as major bleeding or thrombosis.

  • 1 - Xarelto® (rivaroxaban) Summary of Product Characteristics as approved by the European Commission.
  • 26 - Turpie AG. Oral, direct factor Xa inhibitors in development for the prevention and treatment of thromboembolic diseases. Arterioscler Thromb Vasc Biol. 2007;27(6):1238-1247.
  • 29 - Lohrmann J, Becker RC. New anticoagulants—the path from discovery to clinical practice. N Engl J Med. 2008;358(26):2827-2829.
  • 2 - Eriksson BI, Borris LC, Friedman RJ, et al; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
  • 4 - Lassen MR, Ageno W, Borris LC, et al; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.
  • 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.
  • 3 - Kakkar AK, Brenner B, Dahl OE, et al; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39.
  • 7 - Cohen AT, Tapson VF, Bergmann JF, et al; ENDORSE Investigators. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008;371(9610):387-394.
  • 27 - Haas S. New oral Xa and IIa inhibitors: updates on clinical trial results. J Thromb Thrombolysis. 2008;25(1):52-60.
  • 8 - Kubitza D, Haas S. Novel factor Xa inhibitors for prevention and treatment of thromboembolic diseases. Expert Opin Investig Drugs. 2006;15(8):843-855.
  • 30 - Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 suppl):160S-198S.
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.
Venous thromboembolism
A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
Efficacy
The ability of a drug to produce the desired effect.
Major orthopaedic surgery
Major operations on the bones or joints including total hip or knee replacement surgery.
Subcutaneous
Introduced beneath the skin.
Thrombosis
Formation of a clot inside a blood vessel.

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The number of in-hospital deaths due to VTE is five times the total number of deaths from all hospital-acquired infections. 59

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