Use of Rivaroxaban for Prevention of Thromboembolism after Major Joints Arthroplasty under Conditions of Real Clinical Practice in Russia (on the data of prospective multicenter non-interventional study SOPRANO)



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Abstract

Results of first Russian local prospective multicenter observational study with participation of 2293 patients who received rivaroxaban for prevention of thromboembolism after major joints arthroplasty are presented. The study was performed under conditions of “real clinical practice”, i.e. without any changes in postoperative management. Demographic indices, prevalence of aggravating anamnestic factors that determined the risk of thromboembolism development, and adverse effects (AE) against the background of drug intake were studied. Interruptions of rivaroxaban intake were noted in 5% of patients. The number of AE made up 52 in 45 patients and only in 11 cases AE were associated with rivaroxaban intake. Drug efficacy and tolerance was assessed by physicians as excellent and good in 97.9% and 98.8% of patients, respectively. The overwhelming majority (98.4%) of patients appreciated the convenience of oral anticoagulant intake. It was stated that under conditions of the organizational peculiarities of medical care in Russia the efficacy of rivaroxaban was comparable to that, demonstrated in foreign studies.

About the authors

N. V Zagorodniy

Central Institute of Traumatology and Orthopaedics named after N.N. Priorov, Moscow, Russia

Email: artro@mail.ru

K. M Bukhtin

Central Institute of Traumatology and Orthopaedics named after N.N. Priorov, Moscow, Russia

References

  1. Тихилов Р.М., Стойко Ю.М., Замятин М.Н., Божкова С.А. Профилактика тромбоэмболических осложнений в травматологии и ортопедии: Методические рекомендации. М.; 2006.
  2. Hirsh J. et al. ACA/ACC Expert Consensus Document on Warfarin Therapy American Heart Association/American College of Cardiology Foundation Guide to Warfarin Therapy. JACC 2003; 41: 633-52.
  3. Pascual J., Diener H.C., Massiou H. Value of postmarketing surveillance studies in achieving a complete picture of antimigraine agents: using almotriptan as an example. J. Headache Pain. 2006; 7 (1): 27-33.
  4. Turpie A.G., Lassen M.R., Davidson B.L., Bauer K.A., Gent M., Kwong L.M. et al; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16; 373 (9676): 1673-80.
  5. Perzborn E., Harwardt M. Recombinant Factor VII apartially reverses the effects of the Factor Xa inhibitor rivaroxaban on thrombin generation, but not the effects of thrombin inhibitors, in vitro. J. Thromb. Haemost. 2007; 5 Suppl 2: Abstract P-W-640.
  6. Arepally G., Cines D.B. Pathogenesis of heparin-induced thrombocytopenia and thrombosis. Autoimmun Rev. 2002; 1 (3): 125-32.
  7. Bounameaux H. The novel anticoagulants: entering a new era. Swiss Med. Wkly. 2009; 139 (5-6): 60-64.
  8. NICE. Venous thromboembolism: reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in inpatients undergoing surgery. NICE clinical guidelines. www.nice. org.uk/nicemedia/pdf/VTEFullGuide.pdf (accessed May 23, 2008).
  9. Стойко Ю.М., Замятин Н.М. Специфическая профилактика тромбоэмболических осложнений у пациентов с высоким и очень высоким риском. Трудный пациент. 2007; 6-7: 40-3.
  10. Ciccone W.J. 2nd, Fox P.S., Neumyer M. et al. Ultrasound surveillance for asymptomatic deep venous thrombosis after total joint replacement. J. Bone Joint Surg. Am. 1998; 80 (8): 1167-74.
  11. Biemond B.J., Perzborn E., Friederich P.W., Levi M., Buetehorn U., Büller H.R. Prevention and treatment of experimental thrombosis in rabbits with rivaroxaban (BAY 597939) - an oral, direct factor Xa inhibitor. Thromb. Haemost. 2007; 97 (3): 471-7.
  12. Prandoni P., Bruchi O., Sabbion P., et al. Prolonged thromboprophylaxis with oral anticoagulants after total hip arthroplasty: a prospective controlled randomized study. Arch Intern Med 2002; 162: 1966-71.
  13. Friedman R. J. Optimal duration of prophylaxis for venous thromboembolism following total hip arthroplasty and total knee arthroplasty. J. Am. Acad. Orthop. Surg.2007; 15 (3): 148-55.
  14. Turpie A.G. Oral, direct factor Xa inhibitors in development for the prevention and treatment of thromboembolic diseases. Arterioscler. Thromb. Vasc. Biol. 2007; 27 (6): 1238-47.
  15. Perzborn E. FEIBA reverses the effects of a high dose of rivaroxaban in rats. Pathophysiol. Haemost. Thromb. 2008; 36: A40 AbstractP061.
  16. Pirmohamed M. Warfarin: almost 60 years old and still causing problems. Br. J. Clin. Pharmacol. 2006; 62: 509-11.
  17. Planes A., Vochelle N., Darmon J.Y., Fagola M., Bellaud M., Huet Y. Risk of deep-venous thrombosis aft er hospital discharge in patients having undergone total hip replacement: double-blind randomised comparison of enoxaparin versus placebo. Lancet. 1996; 348: 224-8.
  18. Eriksson B.I., Borris L., Dahl O.E., Haas S., Huisman M.V., Kakkar A.K. et al; ODIXa-HIP Study Investigators. Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement. J. Thromb. Haemost. 2006; 4 (1) : 121-8.
  19. Eriksson B.I., Borris L.C., Dahl O.E. et al. A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement. Circulation 2006; 114: 2374-81.
  20. Weinz C., Buetehorn U., Daehler H.P., et al. Pharmacokinetics of BAY 59-7939 - an oral, direct Factor Xa inhibitor - in rats and dogs. Pathophysiol. Haemost. Thromb. 2004; 33 Suppl2: Abstract PO054.
  21. Weinz C., Schwartz T., Pleiss U., Schmeer K., Kubitza D., Mueck W. et al. Metabolism and distribution of [14C]BAY59-7939 - an oral, direct factor Xa inhibitor - in rat, dog and human. Drug Metab. Rev. 2004; 36 (suppl1): 98. Abstract 196.
  22. Turpie A., Kassen M., Kakkar A., Eriksson B., Misselwitz F., Bandel T.J. et al. A pooled analysis of four pivotal studies of rivaroxaban for the prevention of venous tromboembolism after ortopaedic surgery: effect on symptomatic venous tromboembolism, death, and bleeding. Blood. 2008; 112: 36.
  23. Turpie A.G., Fisher W.D., Bauer К.A. 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: 2479-86.
  24. Annex 1 Summary of Product Characteristics Rivaroxaban.
  25. Kubitza D., Becka M., Zuehlsdorf M., Mueck W. Body weight has limited influence on the safety, tolerability, pharmacokinetics, or pharmacodynamics of rivaroxaban (BAY 59-7939) in healthy subjects. J. Clin. Pharmacol. 2007; 47 (2): 218-26.
  26. Kubitza D., Becka M., Zuehlsdorf M., Mueck W. Effects of single-dose BAY 59-7939 - an oral, direct Factor Xa inhibitor - in subjects with extreme body weight. Blood. 2005; 106: Abstract 1872.
  27. Kubitza D., Becka M., Mueck W. et al. The effect of extreme age, and gender, on the pharmacology and tolerability of rivaroxaban - an oral direct factor Xa inhibitor. Blood. 2006; 108: Abstract 905.
  28. Kubitza D., Becka M., Zuehlsdorf M., Mueck W. No interaction between the novel, oral direct Factor Xa inhibitor BAY59-7939 and digoxin. J. Clin. Pharmacol. 2006; 46: Abstract 11.
  29. Kubitza D., Haas S. Novel factor Xa inhibitors for prevention and treatment of thromboembolic diseases. Expert. Opin. Investig. Drugs. 2006; 15 (8): 843-55.
  30. Kubitza D., Becka M., Mueck W., Zuehlsdorf M. Safety, tolerability, pharmacodynamics, and pharmacokinetics of rivaroxaban - an oral, direct Factor Xa inhibitor - are not affected by aspirin. J. Clin. Pharmacol. 2006; 46: 981-90.
  31. Kubitza D., Becka M., Voith B., Zuehlsdorf M., Wensing G. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY59-7939, an oral, direct factor Xa inhibitor. Clin. Pharmacol. Ther. 2005; 78: 412-421.
  32. Kubitza D., Becka M., Wensing G., Voith B., Zuehlsdorf M. 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.
  33. Lassen M.R., Ageno W., Borris L.C., Lieberman J.R., Rosencher N., Bandel T.J. et al.; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N. Engl. J. Med. 2008; 358 (26): 2776-86.
  34. Michota F.A. Prevention of venous thromboembolism after surgery. Cleve Clin. J. Med. 2009; 76 Suppl 4: S45-52.
  35. Kubitza D, Becka M, Mueck W, Zuehlsdorf M. Rivaroxaban (BAY59-7939) - an oral, direct Factor Xa inhibitor has no clinically relevant interaction with naproxen. Br. J. Clin. Pharmacol. 2007; 63: 469-76.
  36. Optimizing anticoagulation technology in the hospital setting-safe and cost-effective strategies for thrombosis prophylaxis and treatment. Findings and recommendations of the CLOT (Cost-Lowering Options for Optimizing Thromboprophylaxis). Clinical Consensus Panel. 2006.
  37. Scottish Intercollegiate Guidelines Network (SIGN). Prophylaxis of venous thromboembolism. A national clinical guideline. Edinburgh: SIGN Publication, 2002.
  38. Turpie A., Kassen M., Kakkar A., Eriksson B., Misselwitz F., Bandel T.J., et al. A pooled analysis of four pivotal studies of rivaroxaban for the prevention of venous tromboembolism after ortopaedic surgery: effect on symptomatic venous tromboembolism, death, and bleeding. Blood. 2008; 112: 36.

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