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Siste oppdatering 01 Feb 2018

Efficacy - Superior Clot Prevention

Benefits of the first one-tablet, once-daily direct Factor Xa inhibitor

Xarelto®, taken as one tablet once daily, is significantly more effective than enoxaparin in preventing venous blood clots that may lead to deep vein thrombosis (DVT) and pulmonary embolism (PE) in adult patients undergoing elective hip or knee replacement surgery. This has been shown in head-to-head comparisons with enoxaparin when both drugs were given over the same time period (RECORD1 over 5 weeks and RECORD3 over 2 weeks), and when comparing extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin (RECORD2). The improved efficacy of Xarelto® is accompanied by a low rate of major and non-major bleeding events similar to that of enoxaparin.2, 3, 4
Xarelto® provides:2, 4
  • Superior efficacy compared with enoxaparin in reducing total VTE *
  • Significant risk reduction in symptomatic VTE compared with enoxaparin†
  • Similar and low rate of major and non-major bleeding compared with enoxaparin

*Based on RECORD1 and RECORD3 †Based on RECORD3

Venous thromboembolism (VTE) is the immediate cause of death in about 10% of patients who die in the hospital.5 Major orthopaedic surgery, such as hip and knee replacement surgery, is associated with a high incidence of post-operative VTE.6 While current guidelines recommend pharmacological VTE prevention for patients undergoing such surgery, a significant number of patients undergoing major orthopaedic surgery are not getting preventive treatment.7
  • Extensive clinical data clearly demonstrate that the use of Xarelto® can lower the rates of DVT and PE in patients after elective hip or knee replacement surgery compared with enoxaparin2, 4
  • 10 mg of Xarelto® given as one tablet once daily combines excellent efficacy with a reassuring safety profile2, 3, 4
  • Xarelto® may simplify anticoagulation compared with existing therapies by avoiding subcutaneous administration or dose tailoring. This is expected to save nursing as well as physician time and to improve patient compliance and care8
  • The first dose of Xarelto® is given 6 to 10 hours post-operatively in patients after total hip or total knee replacement surgery. Thus patients do not need to be in the hospital hours before surgery; in the European regimen the first dose of a low-molecular-weight heparin (LMWH) is given 12 hours pre-operatively1, 2, 3, 4, 6
  • The favourable pharmacokinetic properties of Xarelto® include high bioavailability, a rapid onset of action, and a relatively short half-life, leading to predictable pharmacodynamic effects1, 8
  • Xarelto® was found to be well tolerated and efficacious in a wide range of patient groups (age, weight, BMI), with no need for dose adaptation1, 2, 3, 4, 6, 8
  • Studies with Xarelto® show that routine monitoring of platelet counts, liver enzymes, and coagulation parameters is not necessary. This adds to the convenience for both physicians and patients 1, 2, 3, 4

Impressive findings in VTE prevention supported by extensive clinical evidence

Xarelto® is being characterised in an extensive clinical trial programme covering multiple indications. It is the most studied direct Factor Xa inhibitor to date, with more than 32,000 patients already evaluated or enrolled in clinical studies. More than 50,000 patients are expected to be included in the overall clinical development programme.64
The completed phase III study programme RECORD (REgulation of Coagulation in ORthopaedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) comprises an international series of four phase III clinical studies in more than 12,500 patients undergoing total hip or total knee replacement surgery. Patients who were randomised to Xarelto® included both genders, multiple ethnicities, and a broad range of age (18 to 93 years) as well as weight (33 to 190 kg) groups.2, 3, 4
The results of the RECORD programme (RECORD1, RECORD2, and RECORD3) have been published in two of the world’s most prestigious medical journals: RECORD1 and RECORD3 featured in two papers in The New England Journal of Medicine and RECORD2 in one paper in The Lancet.2, 3, 4

RECORD study designs

Xarelto® given as one tablet once daily was compared with one subcutaneous injection a day of enoxaparin for VTE prevention in total hip replacement (THR) or total knee replacement (TKR). Xarelto® and enoxaparin were administered for the same duration in every RECORD study except for RECORD2, which compared extended-duration Xarelto® to short-term enoxaparin.2, 3, 4, 10

The primary outcome measure was the composite of any DVT, non-fatal PE, and all-cause mortality.2, 3, 4

Secondary outcome measures included:
  • Incidence of the composite endpoint comprising proximal DVT, non-fatal PE, and VTE-related death
  • Incidence of symptomatic VTE (DVT, PE)
  • Incidence of DVT (total proximal and distal)
  • Incidence of bleeds 2, 3, 4

  • 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.
  • 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.
  • 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.
  • 5 - Anderson FA Jr, Zayaruzny M, Heit JA, Fidan D, Cohen AT. Estimated annual numbers of US acute-care hospital patients at risk for venous thromboembolism. Am J Hematol. 2007;82(9):777-782.
  • 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.
  • 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.
  • 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.
  • 1 - Xarelto® (rivaroxaban) Summary of Product Characteristics as approved by the European Commission.
  • 64 - Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S. [press release] Available at http://www.viva.vita.bayerhealthcare.com/index.php?id=36&tx_ttnews[tt_news]=12625&cHash=97a2ea4a90
  • 10 - Data on file. Turpie, 2008 EFORT Presentation RECORD4.
The ability of a drug to produce the desired effect.
Formation of a clot inside a blood vessel.
Venous thromboembolism
A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
Major orthopaedic surgery
Major operations on the bones or joints including total hip or knee replacement surgery.
Introduced beneath the skin.
Deep vein thrombosis
A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
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.
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.
Composite endpoint
A combination of two or more endpoints in a clinical trial.

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The clinical phase III landmark study RECORD2 has been published in The Lancet. 3

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