Rivaroxaban for thromboprophylaxis after orthopaedic surgery: Pooled analysis of two studies

Thrombosis and Haemostasis

Volumn 97, Issue 6, 2007, Pages 931-937

  Fisher, William D ^a   Eriksson, Bengt I ^b   Bauer, Kenneth A ^c   Borris, Lars ^d   Dahl, Ola E ^e   Gent, Michael ^f   Haas, Sylvia ^g   Homering, Martin ^h   Huisman, Menno V ⁱ   Kakkar, Ajay K ^j   Kälebo, Peter ^b   Kwong, Louis M ^k   Misselwitz, Frank ^h   Turpie, Alexander G G ^f  

^a MCGILL UNIVERSITY HEALTH CENTRE   (Canada)

^b SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^c BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^d AARHUS UNIVERSITY HOSPITAL   (Denmark)

^e THROMBOSIS RESEARCH INSTITUTE   (United Kingdom)

^f HHS General Hospital   (Canada)

^g Institute for Experimental Oncology and Therapy Research   (Germany)

^h BAYER PHARMA AG   (Germany)

ⁱ LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^j QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^k HARBOR UCLA MEDICAL CENTER   (United States)

more..

Author keywords

Orthopaedic surgery; Rivaroxaban; Total hip replacement; Total knee replacement; Venous thromboembolism

Indexed keywords

BLOOD CLOTTING FACTOR 10A INHIBITOR; ENOXAPARIN; RIVAROXABAN;

ANTICOAGULANT THERAPY; BLEEDING; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; DEEP VEIN THROMBOSIS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; HUMAN; LUNG EMBOLISM; MORTALITY; ORTHOPEDIC SURGERY; PHASE 2 CLINICAL TRIAL; PHLEBOGRAPHY; POSTOPERATIVE THROMBOSIS; PRIORITY JOURNAL; QT INTERVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TOTAL HIP PROSTHESIS; TOTAL KNEE REPLACEMENT; VENOUS THROMBOEMBOLISM;

ADULT; AGED; AGED, 80 AND OVER; ARTHROPLASTY, REPLACEMENT, HIP; ARTHROPLASTY, REPLACEMENT, KNEE; DOSE-RESPONSE RELATIONSHIP, DRUG; ENOXAPARIN; FEMALE; FIBRINOLYTIC AGENTS; HEMORRHAGE; HUMANS; INCIDENCE; MALE; MIDDLE AGED; MORPHOLINES; PHLEBOGRAPHY; PULMONARY EMBOLISM; THIOPHENES; TREATMENT OUTCOME; VENOUS THROMBOSIS;

EID: 34250645346     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/TH07-01-0055     Document Type: Conference Paper

References (24)

1. Ansell J, Bergqvist D. Current options in the prevention of thromboembolic disease. Drugs 2004; 64: 1-5.
2. Weitz JI, Bates SM. New anticoagulants. J Thromb Haemost 2005; 3: 1843-1853.
3. Becker RC, Alexander J, Dyke CK, et al. Development of DX-9065a, a novel direct factor Xa antagonist, in cardiovascular disease. Thromb Haemost 2004; 92: 1182-1193.
4. Perzborn E, Strassburger J, Wilmen A, et al. In vitro and in vivo studies of the novel antithrombotic agent BAY 59-7939 - an oral, direct Factor Xa inhibitor. J Thromb Haemost 2005; 3: 514-521.
5. Biemond BJ, Perzborn E, Friederich PW, et al. Prevention and treatment of experimental thrombosis in rabbits with rivaroxaban (BAY 59-7939) - an oral, direct factor Xa inhibitor. Thromb Haemost 2007; 97: 471-477.
6. Kubitza D, Becka M, Voith B, et al. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor. Clin Pharmacol Ther 2005; 78: 412-421.
7. Kubitza D, Becka M, Wensing G, et al. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939 - an oral, direct Factor Xa inhibitor-after multiple dosing in healthy male subjects. Eur J Clin Pharmacol 2005; 61: 873-880.
8. Kubitza D, Mueck W, Becka M. The oral, direct Factor Xa inhibitor BAY 59-7939 does not prolong the QTc interval. J Clin Pharmacol 2006; 46: 703 (Abstract 12).
9. Kubitza D, Becka M, Mueck W, et al. Rivaroxaban (BAY 59-7939) - an oral, direct Factor Xa inhibitor - has no clinically relevant interaction with naproxen. Br J Clin Pharmacol 2007; 63: 469-476.
10. Kubitza D, Becka M, Mueck W, et al. Safety, tolerability, pharmacodynamics, and pharmacokinetics of rivaroxaban - an oral, direct Factor Xa inhibitor-are not affected by aspirin. J Clin Pharmacol 2006; 46: 981-990.
11. Kubitza D, Becka M, Zuehlsdorf M, et al. No interaction between the novel, oral direct Factor Xa inhibitor BAY 59-7939 and digoxin. J Clin Pharmacol 2006; 46: 702 (Abstract 11).
12. Kubitza D, Becka M, Zuehlsdorf M, et al. Effect of food, an antacid, and the H2 antagonist ranitidine on the absorption of BAY 59-7939 (rivaroxaban), an oral, direct factor Xa inhibitor, in healthy subjects. J Clin Pharmacol 2006; 46: 549-558.
13. Eriksson BI, Borris L, Dahl OE, et al. Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement. J Thromb Haemost 2006; 4: 121-128.
14. Turpie AG, Fisher WD, Bauer KA, et al. BAY 59-7939: an oral, direct Factor Xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement. A phase II dose-ranging study. J Thromb Haemost 2005; 3: 2479-2486.
15. Rabinov K, Paulin S. Roentgen diagnosis of venous thrombosis in the leg. Arch Surg 1972; 104: 134-144.
16. Kalebo P, Ekman S, Lindbratt S, et al. Percentage of inadequate phlebograms and observer agreement in thromboprophylactic multicenter trials using standardized methodology and central assessment. Thromb Haemost 1996; 76: 893-896.
17. Eriksson BI, Borris LC, Dahl OE, et al. Dose-escalation study of rivaroxaban (BAY 59-7939) - an oral, direct Factor Xa inhibitor - for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Res 2007; doi:10.1016/j.thromres. 2006.12.025.
18. Eriksson BI, Borris LC, Dahl OE, et al. A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement. Circulation 2006; 114: 2374-2381.
19. Agnelli G, Gallus A, Goldhaber S, et al. Treatment of acute, symptomatic, proximal deep vein thrombosis with the oral, direct Factor Xa inhibitor rivaroxaban (BAY 59-7939) - the ODIXa-DVT dose-ranging study. Eur Heart J 2006; 27 (Suppl): 761.
20. Buller HR. Once-daily treatment with an oral, direct factor Xa inhibitor - rivaroxaban (BAY 59-7939) - in patients with acute, symptomatic deep vein thrombosis. The EINSTEIN-DVT dose-finding study. Eur Heart J 2006; 27 (Suppl): 761.
21. Eriksson BI, Bergqvist D, Kalebo P, et al. Ximelagatran and melagatran compared with dalteparin for prevention of venous thromboembolism after total hip or knee replacement: the METHRO II randomised trial. Lancet 2002; 360: 1441-1447.
22. Eriksson BI, Dahl OE, Buller HR, et al. A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial. J Thromb Haemost 2005; 3: 103-111.
23. Geerts WH, Pineo GF, Heit JA, et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 338S-400S.
24. Gillespie W, Murray D, Gregg PJ, et al. Risks and benefits of prophylaxis against venous thromboembolism in orthopaedic surgery. J Bone Joint Surg Br 2000; 82: 475-479.