Table of Contents Author Guidelines Submit a Manuscript
Advances in Hematology
Volume 2011, Article ID 196135, 12 pages
http://dx.doi.org/10.1155/2011/196135
Review Article

Role of Factor Xa Inhibitors in Cancer-Associated Thrombosis: Any New Data?

1Pharmacy Clinical Programs, Division of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
2Section of Benign Hematology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
3Department of Cardiology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
4Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

Received 21 July 2011; Revised 10 August 2011; Accepted 11 August 2011

Academic Editor: Shaji Kumar

Copyright © 2011 Ali Zalpour et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. A. Varki, “Trousseau's syndrome: multiple definitions and multiple mechanisms,” Blood, vol. 110, no. 6, pp. 1723–1729, 2007. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  2. D. Bergqvist, “Risk of venous thromboembolism in patients undergoing cancer surgery and options for thromboprophylaxis,” Journal of Surgical Oncology, vol. 95, no. 2, pp. 167–174, 2007. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  3. A. Stanley and A. Young, “Primary prevention of venous thromboembolism in medical and surgical oncology patients,” British Journal of Cancer, vol. 102, no. 1, pp. S10–S16, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  4. A. A. Khorana, C. W. Francis, E. Culakova, N. M. Kuderer, and G. H. Lyman, “Frequency, risk factors, and trends for venous thromboembolism among hospitalized cancer patients,” Cancer, vol. 110, no. 10, pp. 2339–2346, 2007. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  5. National Comprehensive Cancer Network Clinical Practice in Oncology, “Venous thromboembolic disease,” 2010, http://www.nccn.org/.
  6. G. H. Lyman, A. A. Khorana, A. Falanga et al., “American Society of Clinical Oncology Guideline: recommendations for venous thromboembolism prophylaxis and treatment in patients with cancer,” Journal of Clinical Oncology, vol. 25, no. 34, pp. 5490–5505, 2007. View at Publisher · View at Google Scholar · View at PubMed
  7. W. H. Geerts, D. Bergqvist, G. F. Pineo et al., “Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition),” Chest, vol. 133, no. 6, pp. 381S–453S, 2008. View at Publisher · View at Google Scholar · View at PubMed
  8. C. Kearon, S. R. Kahn, G. Agnelli, S. Goldhaber, G. E. Raskob, and A. J. Comerota, “Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition),” Chest, vol. 133, no. 6, pp. 454S–545S, 2008. View at Publisher · View at Google Scholar · View at PubMed
  9. B. Saraiya and S. Goodin, “Management of venous thromboembolism and the potential to impact overall survival in patients with cancer,” Pharmacotherapy, vol. 29, no. 11, pp. 1344–1356, 2009. View at Publisher · View at Google Scholar · View at PubMed
  10. E. A. Akl, G. Kamath, V. Yosuico et al., “Thromboprophylaxis for patients with cancer and central venous catheters,” Cancer, vol. 112, no. 11, pp. 2483–2492, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  11. P. L. Gross and J. I. Weitz, “New antithrombotic drugs,” Clinical Pharmacology and Therapeutics, vol. 86, no. 2, pp. 139–146, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  12. M. N. Levine, “New antithrombotic drugs: potential for use in oncology,” Journal of Clinical Oncology, vol. 27, no. 29, pp. 4912–4918, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  13. J. M. Walenga, W. P. Jeske, M. M. Samama, F. X. Frapaise, R. L. Bick, and J. Fareed, “Fondaparinux: a synthetic heparin pentasaccharide as a new antithrombotic agent,” Expert Opinion on Investigational Drugs, vol. 11, no. 3, pp. 397–407, 2002. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  14. A. G. G. Turpie, “Fondaparinux: a factor Xa inhibitor for antithrombotic therapy,” Expert Opinion on Pharmacotherapy, vol. 5, no. 6, pp. 1373–1384, 2004. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  15. N. A. Reynolds, C. M. Perry, and L. J. Scott, “Fondaparinux sodium: a review of its use in the prevention of venous thromboembolism following major orthopaedic surgery,” Drugs, vol. 64, no. 14, pp. 1575–1596, 2004. View at Publisher · View at Google Scholar · View at Scopus
  16. H. J. Rupprecht and R. Blank, “Clinical pharmacology of direct and indirect factor xa inhibitors,” Drugs, vol. 70, no. 16, pp. 2153–2170, 2010. View at Google Scholar · View at Scopus
  17. J. Harenberg, “Development of idraparinux and idrabiotaparinux for anticoagulant therapy,” Thrombosis and Haemostasis, vol. 102, no. 5, pp. 811–815, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  18. GlaxoSmithKline Inc, Arixtra (fondaparinux) Prescribing Information, GlaxoSmithKline, Research Triangle Park, NC, USA, 2010.
  19. I. Ahrens, G. Y. H. Lip, and K. Peter, “New oral anticoagulant drugs in cardiovascular disease,” Thrombosis and Haemostasis, vol. 104, no. 1, pp. 49–60, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  20. F. Donat, J. P. Duret, A. Santoni et al., “The pharmacokinetics of fondaparinux sodium in healthy volunteers,” Clinical Pharmacokinetics, vol. 41, no. 2, pp. 1–9, 2002. View at Google Scholar · View at Scopus
  21. A. T. Cohen, B. L. Davidson, A. S. Gallus et al., “Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial,” British Medical Journal, vol. 332, no. 7537, pp. 325–327, 2006. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  22. A. G. G. Turpie, K. A. Bauer, J. A. Caprini, P. C. Comp, M. Gent, and J. E. Muntz, “Fondaparinux combined with intermittent pneumatic compression vs. intermittent pneumatic compression alone for prevention of venous thromboembolism after abdominal surgery: a randomized, double-blind comparison,” Journal of Thrombosis and Haemostasis, vol. 5, no. 9, pp. 1854–1861, 2007. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  23. G. Agnelli, D. Bergqvist, A. T. Cohen, A. S. Callus, and M. Gent, “Randomized clinical trial of postoperative fondaparinux versus perioperative dalteparin for prevention of venous thromboembolism in high-risk abdominal surgery,” British Journal of Surgery, vol. 92, no. 10, pp. 1212–1220, 2005. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  24. H. R. Büller, B. L. Davidson, H. Decousus et al., “Subcutaneous Fondaparinux versus Intravenous Unfractionated Heparin in the Initial Treatment of Pulmonary Embolism,” The New England Journal of Medicine, vol. 349, no. 18, pp. 1695–1702, 2003. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  25. H. R. Büller, B. L. Davidson, H. Decousus et al., “Fondaparinux or enoxaparin for the initial treatment of symptomatic deep vienous thrombosis: a randomized trial,” Annals of Internal Medicine, vol. 140, no. 11, 2004. View at Google Scholar · View at Scopus
  26. R. Helou, “Should we continue to use the Cockcroft-Gault formula?” Nephron—Clinical Practice, vol. 116, no. 3, pp. c172–c185, 2010. View at Publisher · View at Google Scholar · View at PubMed
  27. F. F. van Doormaal, G. E. Raskob, B. L. Davidson et al., “Treatment of venous thromboembolism in patients with cancer: subgroup analysis of the Matisse clinical trials,” Thrombosis and Haemostasis, vol. 101, no. 4, pp. 762–769, 2009. View at Publisher · View at Google Scholar
  28. B. L. Davidson, H. R. Büller, H. Decousus et al., “Effect of obesity on outcomes after fondaparinux, enoxaparin, or heparin treatment for acute venous thromboembolism in the Matisse trials,” Journal of Thrombosis and Haemostasis, vol. 5, no. 6, pp. 1191–1194, 2007. View at Publisher · View at Google Scholar · View at PubMed
  29. I. Gouin-Thibault, E. Pautas, I. Mahé et al., “Is modification of diet in renal disease formula similar to Cockcroft-Gault formula to assess renal function in elderly hospitalized patients treated with low-molecular-weight heparin?” Journals of Gerontology—Series A, vol. 62, no. 11, pp. 1300–1305, 2007. View at Google Scholar
  30. C. Melloni, E. D. Peterson, A. Y. Chen et al., “Cockcroft-gault versus modification of diet in renal disease. Importance of glomerular filtration rate formula for classification of chronic kidney disease in patients with non-ST-segment elevation acute coronary syndromes,” Journal of the American College of Cardiology, vol. 51, no. 10, pp. 991–996, 2008. View at Publisher · View at Google Scholar · View at PubMed
  31. A. G. G. Turpie, A. W. A. Lensing, T. Fuji, and D. A. Boyle, “Pharmacokinetic and clinical data supporting the use of fondaparinux 1.5 mg once daily in the prevention of venous thromboembolism in renally impaired patients,” Blood Coagulation and Fibrinolysis, vol. 20, no. 2, pp. 114–121, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  32. K. I. Sombolos, T. K. Fragia, L. C. Gionanlis et al., “Use of fondaparinux as an anticoagulant during hemodialysis: a preliminary study,” International Journal of Clinical Pharmacology and Therapeutics, vol. 46, no. 4, pp. 198–203, 2008. View at Google Scholar · View at Scopus
  33. R. M. Kalicki, F. Aregger, L. Alberio, B. Lämmle, F. J. Frey, and D. E. Uehlinger, “Use of the pentasaccharide fondaparinux as an anticoagulant during haemodialysis,” Thrombosis and Haemostasis, vol. 98, no. 6, pp. 1200–1207, 2007. View at Publisher · View at Google Scholar · View at Scopus
  34. W. E. Dager and T. H. Kiser, “Systemic anticoagulation considerations in chronic kidney disease,” Advances in Chronic Kidney Disease, vol. 17, no. 5, pp. 420–427, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  35. M. M. Samama and G. T. Gerotziafas, “Evaluation of the pharmacological properties and clinical results of the synthetic pentasaccharide (fondaparinux),” Thrombosis Research, vol. 109, no. 1, pp. 1–11, 2003. View at Publisher · View at Google Scholar · View at Scopus
  36. C. Klaeffling, G. Piechottka, G. Daemgen-von Brevern et al., “Development and clinical evaluation of two chromogenic substrate methods for monitoring fondaparinux sodium,” Therapeutic Drug Monitoring, vol. 28, no. 3, pp. 375–381, 2006. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  37. R. C. Gosselin, J. H. King, K. A. Janatpur, W. H. Dager, E. C. Larkin, and J. T. Owings, “Effects of pentasaccharide (Fondaparinux) and direct thrombin inhibitors on coagulation testing,” Archives of Pathology and Laboratory Medicine, vol. 128, no. 10, pp. 1142–1145, 2004. View at Google Scholar · View at Scopus
  38. L. A. Linkins, J. A. Julian, J. Rischke, J. Hirsh, and J. I. Weitz, “In vitro comparison of the effect of heparin, enoxaparin and fondaparinux on tests of coagulation,” Thrombosis Research, vol. 107, no. 5, pp. 241–244, 2002. View at Publisher · View at Google Scholar · View at Scopus
  39. A. Smogorzewska, J. T. Brandt, W. L. Chandler et al., “Effect of fondaparinux on coagulation assays: results of College of American pathologists proficiency testing,” Archives of Pathology and Laboratory Medicine, vol. 130, no. 11, pp. 1605–1611, 2006. View at Google Scholar · View at Scopus
  40. F. Depasse, G. T. Gerotziafaz, J. Busson, P. van Dreden, and M. M. Samama, “Assessment of three chromogenic and one clotting assays for the measurement of synthetic pentasaccharide fondaparinux (Arixtra) anti-Xa activity,” Journal of Thrombosis and Haemostasis, vol. 2, no. 2, pp. 346–348, 2004. View at Publisher · View at Google Scholar · View at Scopus
  41. D. Cook, M. Meade, G. Guyatt et al., “Dalteparin versus unfractionated heparin in critically ill patients,” The New England Journal of Medicine, vol. 364, no. 14, pp. 1305–1314, 2011. View at Publisher · View at Google Scholar · View at PubMed
  42. M. A. Perazella, “Drug use and nephrotoxicity in the intensive care unit,” Kidney International. In press. View at Publisher · View at Google Scholar · View at PubMed
  43. G. Cumbo-Nacheli, L. Samavati, and J. A. Guzman, “Bioavailability of fondaparinux to critically ill patients,” Journal of Critical Care, vol. 26, no. 4, pp. 342–346. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  44. T. L. Ortel, “Heparin-induced thrombocytopenia: when a low platelet count is a mandate for anticoagulation,” Hematology, pp. 225–232, 2009. View at Google Scholar · View at Scopus
  45. T. E. Warkentin, “New approaches to the diagnosis of heparin-induced thrombocytopenia,” Chest, vol. 127, no. 2, pp. 35S–45S, 2005. View at Publisher · View at Google Scholar · View at Scopus
  46. M. Prechel and J. M. Walenga, “The laboratory diagnosis and clinical management of patients with heparin-induced thrombocytopenia: an update,” Seminars in Thrombosis and Hemostasis, vol. 34, no. 1, pp. 86–96, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  47. T. E. Warkentin, A. Greinacher, A. Koster, and A. M. Lincoff, “Treatment and prevention of heparin-induced thrombocytopenia: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition),” Chest, vol. 133, no. 6, pp. 340S–380S, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  48. L. E. Efird and D. R. Kockler, “Fondaparinux for thromboembolic treatment and prophylaxis of heparin-induced thrombocytopenia,” The Annals of Pharmacotherapy, vol. 40, no. 7-8, pp. 1383–1387, 2006. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  49. T. E. Warkentin, R. J. Cook, V. J. Marder et al., “Anti-platelet factor 4/heparin antibodies in orthopedic surgery patients receiving antithrombotic prophylaxis with fondaparinux or enoxaparin,” Blood, vol. 106, no. 12, pp. 3791–3796, 2005. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  50. K. H. M. Kuo and M. J. Kovacs, “Successful treatment of heparin induced thrombocytopenia (HIT) with fondaparinux,” Thrombosis and Haemostasis, vol. 93, no. 5, pp. 999–1000, 2005. View at Google Scholar · View at Scopus
  51. J. P. J. Wester, A. Leyte, H. M. Oudemans-van Straaten et al., “Low-dose fondaparinux in suspected heparin-induced thrombocytopenia in the critically ill,” The Netherlands Journal of Medicine, vol. 65, no. 3, pp. 101–108, 2007. View at Google Scholar · View at Scopus
  52. A. B. Blackmer, M. D. Oertel, and J. M. Valgus, “Fondaparinux and the management of heparin-induced thrombocytopenia: the journey continues,” The Annals of Pharmacotherapy, vol. 43, no. 10, pp. 1636–1646, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  53. B. Lobo, C. Finch, A. Howard, and S. Minhas, “Fondaparinux for the treatment of patients with acute heparininduced thrombocytopenia,” Thrombosis and Haemostasis, vol. 99, no. 1, pp. 208–214, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  54. T. E. Warkentin, B. T. Maurer, and R. H. Aster, “Heparin-induced thrombocytopenia associated with fondaparinux,” The New England Journal of Medicine, vol. 356, no. 25, pp. 2653–2654, 2007. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  55. E. Rota, M. Bazzan, and G. Fantino, “Fondaparinux-related thrombocytopenia in a previous low-molecular-weight heparin (LMWH)-induced heparin-induced thrombocytopenia (HIT),” Thrombosis and Haemostasis, vol. 99, no. 4, pp. 779–781, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  56. K. A. Alsaleh, S. M. A. Al-Nasser, S. M. Bates, A. Patel, T. E. Warkentin, and D. M. Arnold, “Delayed-onset HIT caused by low-molecular-weight heparin manifesting during fondaparinux prophylaxis,” American Journal of Hematology, vol. 83, no. 11, pp. 876–878, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  57. C. J. Lee and J. E. Ansell, “Direct thrombin inhibitors,” British Journal of Clinical Pharmacology, vol. 72, no. 4, pp. 581–592, 2011. View at Google Scholar
  58. J. Trujillo-Santos, J. A. Nieto, A. Ruíz-Gamietea et al., “Bleeding complications associated with anticoagulant therapy in patients with cancer,” Thrombosis Research, vol. 125, pp. S58–S61, 2010. View at Google Scholar · View at Scopus
  59. S. Vadhan-Raj, “Management of chemotherapy-induced thrombocytopenia: current status of thrombopoietic agents,” Seminars in Hematology, vol. 46, no. 2, pp. S26–S32, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  60. N. Ruíz-Giménez, C. Suárez, R. González et al., “Predictive variables for major bleeding events in patients presenting with documented acute venous thromboembolism. Findings from the RIETE Registry,” Thrombosis and Haemostasis, vol. 100, no. 1, pp. 26–31, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  61. J. A. Nieto, R. Solano, M. D. Ruiz-Ribó et al., “Fatal bleeding in patients receiving anticoagulant therapy for venous thromboembolism: findings from the RIETE registry,” Journal of Thrombosis and Haemostasis, vol. 8, no. 6, pp. 1216–1222, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  62. M. A. Crowther and T. E. Warkentin, “Bleeding risk and the management of bleeding complications in patients undergoing anticoagulant therapy: focus on new anticoagulant agents,” Blood, vol. 111, no. 10, pp. 4871–4879, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  63. M. Franchini, M. Zaffanello, and D. Veneri, “Recombinant factor VIIa. An update on its clinical use,” Thrombosis and Haemostasis, vol. 93, no. 6, pp. 1027–1035, 2005. View at Publisher · View at Google Scholar · View at Scopus
  64. N. R. Bijsterveld, A. H. Moons, S. M. Boekholdt et al., “Ability of recombinant factor VIIa to reverse the anticoagulant effect of the pentasaccharide fondaparinux in healthy volunteers,” Circulation, vol. 106, no. 20, pp. 2550–2554, 2002. View at Publisher · View at Google Scholar · View at Scopus
  65. T. Lisman, N. R. Bijsterveld, J. Adelmeijer et al., “Recombinant factor VIIa reverses the in vitro and ex vivo anticoagulant and profibrinolytic effects of fondaparinux,” Journal of Thrombosis and Haemostasis, vol. 1, no. 11, pp. 2368–2373, 2003. View at Google Scholar · View at Scopus
  66. G. T. Gerotziafas, F. Depasse, T. Chakroun, M. M. Samama, and I. Elalamy, “Recombinant factor VIIa partially reverses the inhibitor effect of fondaparinux on thrombin generation after tissue factor activation in platelet rich plasma and whole blood,” Thrombosis and Haemostasis, vol. 91, no. 3, pp. 531–537, 2004. View at Google Scholar · View at Scopus
  67. J. Bordes, Y. Asencio, N. Kenane, J. Fesselet, E. Meaudre, and P. Goutorbe, “Recombinant activated factor VII for acute subdural haematoma in an elderly patient taking fondaparinux,” British Journal of Anaesthesia, vol. 101, no. 4, pp. 575–576, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  68. F. Huvers, R. Slappendel, B. Benraad, G. van Hellemondt, and M. van Kraaij, “Treatment of postoperative bleeding after fondaparinux with rFVIIa and tranexamic acid,” The Netherlands Journal of Medicine, vol. 63, no. 5, pp. 184–186, 2005. View at Google Scholar · View at Scopus
  69. M. Levi, J. H. Levy, H. F. Andersen, and D. Truloff, “Safety of recombinant activated factor VII in randomized clinical trials,” The New England Journal of Medicine, vol. 363, no. 19, pp. 1791–1800, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  70. A. V. Joshi, P. Mathew, and T. Gore, “Cost-effectiveness of different treatment regimens consisting of NovoSeven Versus FEIBA VH for the home treatment of minor-to-moderate bleeds in hemophilia patients with inhibitors in the United States: a cost-of-bleed model,” Journal of Thrombosis and Haemostasis, vol. 3, supplement 1, 2005, abstract no. P2035. View at Google Scholar
  71. H. R. Buller, A. T. Cohen, B. Davidson et al., “Idraparinux versus standard therapy for venous thromboembolic disease,” The New England Journal of Medicine, vol. 357, no. 11, pp. 1094–1104, 2007. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  72. F. F. van Doormaal, A. T. Cohen, B. L. Davidson et al., “Idraparinux versus standard therapy in the treatment of deep venous thrombosis in cancer patients: a subgroup analysis of the Van Gogh DVT trial,” Thrombosis and Haemostasis, vol. 104, no. 1, pp. 86–91, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  73. A. Dao, B. Tuan, and N. Carlson, “Reversal of a potent investigational anticoagulant: idraparinux with recombinant factor VIIa,” American Journal of Medicine, vol. 118, no. 10, pp. 1172–1173, 2005. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  74. H. R. Büller, “Efficacy and safety of once weekly subcutaneous idrabiotaparinux in the treatment of patients with symptomatic deep venous thrombosis,” Journal of Thrombosis and Haemostasis, vol. 9, no. 1, pp. 92–99, 2011. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus