Advances in anticoagulation therapy: The role of selective inhibitors of factor Xa and thrombin in thromboprophylaxis after major orthopedic surgery

Seminars in Thrombosis and Hemostasis

Volumn 30, Issue 6, 2004, Pages 609-618

  Andersen, Judith C ^a  

^a WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Fondaparinux; Low molecular weight heparin; Orthopedic surgery; Thromboprophylaxis; Thrombosis; Ximelagatran

Indexed keywords

ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; ANTIVITAMIN K; ARGATROBAN; BLOOD CLOTTING FACTOR 10A; BLOOD CLOTTING FACTOR 10A INHIBITOR; DALTEPARIN; DESULFATOHIRUDIN; DIGOXIN; ENOXAPARIN; FONDAPARINUX; GROWTH HORMONE; HEPARIN; HEPARIN DERIVATIVE; HIRULOG; LEPIRUDIN; LOW MOLECULAR WEIGHT HEPARIN; MELAGATRAN; NEW DRUG; PIROXICAM; PROCOAGULANT; THROMBIN; THROMBIN INHIBITOR; TINZAPARIN; WARFARIN; XIMELAGATRAN;

ANAPHYLACTIC SHOCK; ANTICOAGULATION; BLEEDING; BLOOD CLOTTING; CLINICAL TRIAL; CONFERENCE PAPER; CREUTZFELDT JAKOB DISEASE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INDICATION; DRUG MONITORING; DRUG SAFETY; DRUG SELECTIVITY; DRUG TARGETING; HIP FRACTURE; HUMAN; LIVER FUNCTION; ORTHOPEDIC SURGERY; POSTOPERATIVE CARE; PRIORITY JOURNAL; SIDE EFFECT; THROMBOCYTOPENIA; THROMBOSIS; THROMBOSIS PREVENTION; TOTAL HIP PROSTHESIS; TOTAL KNEE REPLACEMENT; VENOUS THROMBOEMBOLISM;

ANTICOAGULANTS; AZETIDINES; BENZYLAMINES; CLINICAL TRIALS; FACTOR XA; GLYCINE; HEPARIN; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; MODELS, BIOLOGICAL; ORTHOPEDICS; POLYSACCHARIDES; POSTOPERATIVE COMPLICATIONS; THROMBOEMBOLISM; THROMBOLYTIC THERAPY;

EID: 11144313066     PISSN: 00946176     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-2004-861502     Document Type: Conference Paper

References (47)

1. White RH. The epidemiology of venous thromboembolism. Circulation 2003;107(Suppl 1):14-18
2. Geerts WH, Heit JA, Clagett GP, et al. Prevention of venous thromboembolism. Chest 2001;119(Suppl 1):132S-175S
3. American Public Health Association and Centers for Disease Control gather to elevate awareness of deep-vein thrombosis as major health threat. American Public Health Association. Available at: http://www.apha.org/news/press/2003/ dvt.htm. Accessed August 14, 2003
4. Hirsh J, Dalen JE, Anderson DR, et al. Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest 1998;114(Suppl 5):445S-469S
5. Bristol-Myers Squibb. Package Insert: Coumadin® (warfarin sodium tablets, USP), crystalline Coumadin® for injection (warfarin sodium for injection, USP). Princeton, NJ: Bristol-Myers Squibb; 2002
6. Summary of Information Submitted to MEDMARXSM in the Year 2001: A Human Factors Approach to Medication Errors. Rockville, MD: US Pharmacopeia; 2002
7. Hirsh J, Warkentin TE, Shaughnessy SG, et al. Heparin and low-molecular-weight heparin: mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest 2001;(Suppl 1):64S-94S
8. Van Boeckel CA, Petitou M. The unique antithrombin-III binding domain of heparin: a lead to new synthetic antithrombotics. Angew Chem Int Ed Engl 1993;32:1671-1690
9. Quader MA, Stump LS, Sumpio BE. Low molecular weight heparins: current use and indications. J Am Coll Surg 1998;187:641-658
10. Hirsh J, Levine MN. Low molecular weight heparin. Blood 1992;79:1-17
11. Warkentin TE. Heparin-induced thrombocytopenia: IgG-mediated platelet activation, platelet microparticle generation, and altered procoagulant/ anticoagulant balance in the pathogenesis of thrombosis and venous limb gangrene complicating heparin-induced thrombocytopenia. Transfus Med Rev 1996;10:249-258
12. Pharmacia and Upjohn Package Insert: Heparin sodium injection, USP. Kalamazoo, MI: Pharmacia and Upjohn; 2000
13. Warkentin TE, Levine MN, Hirsh J, et al. Heparin-induced thrombocytopenia in patients treated with low-molecular-weight heparin or unfractionated heparin. N Engl J Med 1995;1330:1330-1335
14. Aventis Pharmaceuticals Package Insert: Lovenox® (enoxaparin sodium injection). Bridgewater, NJ: Aventis Pharmaceuticals; 2003
15. Pharmacia and Upjohn Package Insert: Fragmin® (dalteparin sodium injection). Kalamazoo, MI: Pharmacia and Upjohn; 2002
16. Pharmion Package Insert: Innohep® (tinzaparin sodium injection). Boulder, CO: Pharmion; 2003
17. Berlex Package Insert: Refludan® (lepirudin [rDNA] for injection). Wayne, NJ: Berlex; 2002
18. Aventis Pharmaceuticals Package Insert: Iprivask® (desirudin for injection [15 mg]). Bridgewater, NJ: Aventis Pharmaceuticals; 2003
19. The Medicines Co. Package Insert: Angiomax® (bivalirudin) for injection. Parsippany, NJ: The Medicines Co; 2002
20. GlaxoSmithKline Package Insert: Argatroban (injection). Research Triangle Park, NC: GlaxoSmithKline; 2003
21. Eriksson UG, Bredberg U, Hoffmann KJ, et al. Absorption, distribution, metabolism, and excretion of ximelagatran, an oral direct thrombin inhibitor, in rats, dogs, and humans. Drug Metab Dispos 2003;31:294-305
22. Bauer KA, Hawkins DW, Peters PC, et al. Fondaparinux, a synthetic pentasaccharide: the first in a new class of antithrombotic agents - the selective factor Xa inhibitors. Cardiovasc Drug Rev 2002;20:37-52
23. Paolucci F, Clavies MC, Donat F, Necciari J. Fondaparinux sodium mechanism of action: identification of specific binding to purified and human plasma-derived proteins. Clin Pharmacokinet 2002;41(Suppl 2):11-18
24. Lieu C, Shi J, Donat F, et al. Fondaparinux sodium is not metabolised in mammalian liver fractions and does not inhibit cytochrome p450-mediated metabolism of concomitant drugs. Clin Pharmacokinet 2002;41(Suppl 2):19-26
25. Ollier C, Faaij RA, Santoni A, et al. Absence of interaction of fondaparinux sodium with aspirin and piroxicam in healthy male volunteers. Clin Pharmacokinet 2002;41(Suppl 2): 31-37
26. Faaij RA, Burggraaf J, Schoemaker RC, Van Amsterdam RGM, Cohen AF. Absence of an interaction between the synthetic pentasaccharide fondaparinux and oral warfarin. Br J Clin Pharmacol 2002;54:304-308
27. Mant T, Fournié P, Ollier C, Donat F, Necciari J. Absence of interaction of fondaparinux sodium with digoxin in healthy volunteers. Clin Pharmacokinet 2002;41(Suppl 2):39-45
28. Peters PC, Nutescu E, Andersen J. Wound pharmacobiology. Orthopedics 2003;26(Suppl 8):s837-842
29. Ahmad S, Jeske WP, Walenga JM, et al. Synthetic pentasaccharides do not cause platelet activation by antiheparin-platelet factor 4 antibodies. Clin Appl Thromb Hemost 1999;5:259-266
30. Organon Sanofi-Synthelabo LLC Package Insert. Arixtra® (fondaparinux sodium injection). West Orange, NJ: Organon Sanofi-Synthelabo LLC; 2003
31. The REMBRANDT Investigators. Treatment of proximal deep vein thrombosis with a novel synthetic compound (SR90107A/ORG31540) with pure anti-factor Xa activity: a phase II evaluation. Circulation 2000;102:2726-2731
32. The MATISSE Investigators. The MATISSE-DVT trial: a randomized, double-blind study comparing once-daily fondaparinux (Arixtra®) with the low-molecular-weight heparin (LMWH) enoxaparin, twice daily, in the initial treatment of symptomatic deep-vein thrombosis (DVT). J Thromb Haemost 2003;1(Suppl 1):OC332
33. The MATISSE-PE trial. A multicenter, randomized, open study comparing once-daily fondaparinux (Arixtra®) with adjusted-dose intravenous unfractionated heparin (UFH) in the initial treatment of acute symptomatic pulmonary embolism (PE). J Thromb Haemost 2003;1(Suppl 1):OC331
34. Francis CW, Berkowitz SD, Comp PC, et al. Comparison of ximelagatran with warfarin for the prevention of venous thromboembolism after total knee replacement. N Engl J Med 2003;349:1703-1712
35. Francis CW, Davidson BL, Berkowitz SD, et al. Ximelagatran versus warfarin for the prevention of venous thromboembolism after total knee arthroplasty. A randomized, double-blind trial. Ann Intern Med 2002;137:648-655
36. Eriksson BI, Agnelli G, Cohen AT, et al. The oral direct thrombin inhibitor ximelagatran, and its subcutaneous (SC) form melagatran, compared with enoxaparin for prophylaxis of venous thromboembolism (VTE) in total hip or total knee replacement (THR or TKR): the EXPRESS study. Presented at the 44th Annual Meeting of the American Society of Hematology: December 6-10, 2002; Philadelphia, PA (Abst 299)
37. Francis CW, Berkowitz SD, Comp PC, et al. Randomized, double-blind, comparison of ximelagatran, an oral direct thrombin inhibitor, and warfarin to prevent venous thromboembolism (VTE) after total knee replacement (TKR). Presented at the 44th Annual Meeting of the American Society of Hematology: December 6-10, 2002; Philadelphia, PA (Abst 300)
38. Turpie AGG, Gallus AS, Hoek JA, for the Pentasaccharide Investigators. A synthetic pentasaccharide for the prevention of deep-vein thrombosis after total hip replacement. N Engl J Med 2001;344:619-625
39. Eriksson BI, Bauer KA, Lassen MR, Turpie AG, for the Steering Committee of the Pentasaccharide in Hip-Fracture Surgery Study. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after hip-fracture surgery. N Engl J Med 2001;345:1298-1304
40. Bauer KA, Eriksson BI, Lassen MR, Turpie AG, for the Steering Committee of the Pentasaccharide in Major Knee Surgery Study. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery. N Engl J Med 2001;345:1305-1310
41. Lassen MR, Bauer KA, Eriksson BI, Turpie AG, for the European Pentasaccharide Hip Elective Surgery Study (EPHESUS) Steering Committee. Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: a randomised double-blind comparison. Lancet 2002;359:1715-1720
42. Turpie AG, Bauer KA, Eriksson BI, Lassen MR, for the PENTATHLON 2000 Study Steering Committee. Post-operative fondaparinux versus postoperative enoxaparin for prevention of venous thromboembolism after elective hip-replacement surgery: a randomised double-blind trial. Lancet 2002;359:1721-1726
43. Turpie AGG, Bauer KA, Eriksson BI, Lassen MR, for the Steering Committees of the Pentasaccharide Orthopedic Prophylaxis Studies. Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: a meta-analysis of 4 randomized double-blind studies. Arch Intern Med 2002;162:1833-1840
44. Turpie AGG. Efficacy and safety of fondaparinux in major orthopedic surgery according to the timing of its first administration. Thromb Haemost 2003;90:364-366
45. Eriksson BI, Lassen MR. Duration of prophylaxis against venous thromboembolism with fondaparinux after hip fracture surgery: a multicenter, randomized, placebo-controlled, double-blind study. Arch Intern Med 2003;163:1337-1342
46. Lassen M, Bauer KA, Eriksson BI, Turpie AGG. Absence of transaminase increase after 4-week administration of fondaparinux (Arixtra®), a new synthetic and selective inhibitor of factor Xa, in the PENTHIFRA-Plus study. J Thromb Haemost 2003;1(Suppl 1):P2052
47. Hull RD, Pineo GF, Stein PD, et al. Extended out-of-hospital low-molecular-weight heparin prophylaxis against deep venous thrombosis in patients after elective hip arthroplasty: a systematic review. Ann Intern Med 2001;135:858-869