Skip to main content
SpringerLink
Log in

Rivaroxaban

A Review of its Use for the Prophylaxis of Venous Thromboembolism after Total Hip or Knee Replacement Surgery

  • Adis Drug Evaluation
  • Published:
American Journal of Cardiovascular Drugs Aims and scope Submit manuscript

Abstract

Rivaroxaban (Xarelto®), an oral oxazolidinone-based anticoagulant, is a potent, selective, direct inhibitor of factor Xa that is used in the prevention of venous thromboembolism (VTE) in adult patients after total hip replacement (THR) or total knee replacement (TKR) surgery.

In large, clinical trials, oral rivaroxaban 10mg once daily was more effective than subcutaneous enoxaparin 40mg once daily in preventing postoperative VTE in patients undergoing THR or TKR surgery. Rivaroxaban was associated with significantly lower incidences of the primary endpoint, total VTE (composite of deep vein thrombosis, non-fatal pulmonary embolism, or death from any cause) compared with enoxaparin regimens across all studies. For example, in the largest trial in patients undergoing THR, total VTE occurred in 1.1% of rivaroxaban recipients and 3.7% of enoxaparin recipients (absolute risk reduction 2.6% [95% CI 1.5, 3.7]) in the modified intent-to-treat population.

Notably, the greater efficacy of rivaroxaban was achieved without a significant increase in the incidence of major bleeding episodes compared with enoxaparin; bleeding events were the most frequently reported adverse events across clinical trials. Pyrexia, vomiting, nausea, and constipation were the most frequently reported of the non-bleeding treatment-emergent adverse events in rivaroxaban recipients and occurred at a similar rate to that with enoxaparin treatment.

In addition, preliminary pharmacoeconomic analyses in Canada and the US indicate that rivaroxaban is a cost-saving treatment strategy versus enoxaparin.

Although the position of rivaroxaban relative to other therapies remains to be fully determined, it is an effective option for the prophylaxis of VTE following THR and TKR.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Table I
Table II
Fig. 2
Table III
Fig. 3
Table IV

Similar content being viewed by others

References

  1. Hyers TM. Management of venous thromboembolism: past, present, and future. Arch Intern Med 2003; 163 (7): 759–68.

    Article  PubMed  CAS  Google Scholar 

  2. 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 Jun; 133 (6 Suppl.): 381–453S.

    Article  Google Scholar 

  3. Deitelzweig SB, Johnson BH, Lin J, et al. Prevalence of clinical venous thromboembolism in the USA: current trends and future projections. Am J Hematol 2011 Feb. 86 (2): 217–20.

    Article  PubMed  CAS  Google Scholar 

  4. Dahl OE. Orthopaedic surgery as a model for drug development in thrombosis. Drugs 2004; 64 Suppl 1: 17–25.

    Article  PubMed  Google Scholar 

  5. Prandoni P, Lensing AW, Cogo A, et al. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med 1996; 125 (1): 1–7.

    PubMed  CAS  Google Scholar 

  6. Spyropoulos AC, Lin J. Direct medical costs of venous thromboembolism and subsequent hospital readmission rates: an administrative claims analysis from 30 managed care organizations. J Manage Care Pharm 2007 Jul-2007 31. 13 (6): 475–86.

    Google Scholar 

  7. Eriksson BI, Quinlan DJ, Weitz JI, et al. Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor Xa inhibitors in development. Clin Pharmacokinet 2009; 48 (1): 1–22.

    Article  PubMed  CAS  Google Scholar 

  8. Eriksson BI, Quinlan DJ. Oral anticoagulants in development: focus on thromboprophylaxis in patients undergoing orthopaedic surgery. Drugs 2006; 66(11): 1411–29.

    Article  PubMed  CAS  Google Scholar 

  9. 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 Mar. 3 (3): 514–21.

    Article  PubMed  CAS  Google Scholar 

  10. Depasse F, Busson J, Mnich J, et al. Effect of BAY 59–7939: a novel, oral direct factor Xa inhibitor on clot-bound factor Xa activity in vitro [abstract no. P1104]. J Thromb Haemost 2005; 3 (Suppl. 1).

  11. Laux V, Perzborn E, Kubitza D, et al. Preclinical and clinical characteristics of rivaroxaban: a novel, oral, direct factor Xa inhibitor. Semin Thromb Hemost 2007 Jul. 33 (5): 515–23.

    Article  PubMed  CAS  Google Scholar 

  12. Roehrig S, Straub A, Pohlmann J, et al. Discovery of the novel antithrombotic agent 5-chloro-N-((5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl) phenyl]-1,3-ox-azolidin-5-yl methyl) thiophene-2-carboxamide (BAY 59–7939): an oral, direct factor Xa inhibitor. J Med Chem 2005 Sep 22. 48 (19): 5900–8.

    Article  PubMed  CAS  Google Scholar 

  13. Bayer Schering Pharma. Xarelto® (rivaroxaban 10 mg tablets): EU summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk/emc/document.aspx?documentId=21265 [Accessed 2012 Jan 11].

  14. Perzborn E, Lange U. Rivaroxaban: an oral, direct factor Xa inhibitor inhibits tissue factor-mediated platelet aggregation [abstract no. P-W-642]. J Thromb Haemost 2007; 5 (Suppl. 2).

  15. Wong PC, Crain E, Watson C, et al. Comparative antithrombotic and antihemostatic effects of the direct factor Xa inhibitors, apixaban and rivaroxaban, and the direct thrombin inhibitors, dabigatran and lepirudin, in rabbit models of venous thrombosis and bleeding time [abstract no. 3025]. 50th American Society of Hematology Annual Meeting and Exposition; 2008 Dec 6–9; San Francisco (CA).

  16. 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 Oct. 78 (4): 412–21.

    Article  PubMed  CAS  Google Scholar 

  17. 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 Dec. 61 (12): 873–80.

    Article  PubMed  CAS  Google Scholar 

  18. Mueck W, Becka M, Kubitza D, et al. Population model of the pharmacokinetics and pharmacodynamics of rivaroxaban — an oral, direct factor xa inhibitor — in healthy subjects. Int J Clin Pharmacol Ther 2007 Jun. 45 (6): 335–44.

    PubMed  CAS  Google Scholar 

  19. Mueck W, Borris LC, Dahl OE, et al. Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Haemost 2008 Sep. 100 (3): 453–61.

    PubMed  CAS  Google Scholar 

  20. Mueck W, Eriksson BI, Bauer KA, et al. Population pharmacokinetics and pharmacodynamics of rivaroxaban — an oral, direct factor Xa inhibitor — in patients undergoing major orthopaedic surgery. Clin Pharmacokinet 2008; 47 (3): 203–16.

    Article  PubMed  CAS  Google Scholar 

  21. Graff J, von Hentig N, Misselwitz F, et al. Effects of the oral, direct factor Xa inhibitor rivaroxaban on platelet-induced thrombin generation and prothrombinase activity. J Clin Pharmacol 2007 Nov. 47 (11): 1398–407.

    Article  PubMed  CAS  Google Scholar 

  22. Gerotziafas GT, Elalamy I, Depasse F, et al. In vitro inhibition of thrombin generation, after tissue factor pathway activation, by the oral, direct factor Xa inhibitor rivaroxaban [letter]. J Thromb Haemost 2007 Apr. 5 (4): 886–8.

    Article  PubMed  CAS  Google Scholar 

  23. Walenga JM, Prechel M, Jeske WP, et al. Rivaroxaban — an oral, direct factor Xa inhibitor — has potential for the management of patients with heparininduced thrombocytopenia. Br J Haematol 2008 Jul 30. 143: 92–9.

    Article  PubMed  CAS  Google Scholar 

  24. Kubitza D, Becka M, Mueck W, et al. Rivaroxaban (BAY 59–7939) — an oral, direct factor Xa inhibitor — has no clinically relevant interaction with napro-xen. Br J Clin Pharmacol 2007 Apr. 63 (4): 469–76.

    Article  PubMed  CAS  Google Scholar 

  25. 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 Sep. 46 (9): 981–90.

    Article  PubMed  CAS  Google Scholar 

  26. Kubitza D, Becka M, Mueck W, et al. Co-administration of rivaroxaban — a novel, oral, direct factor Xa inhibitor — and clopidogrel in healthy subjects [abstract no. 1272]. Eur Heart J 2007 Sep; 28 (Abstr. Suppl.): 189.

    Google Scholar 

  27. Kubitza D, Mueck W, Becka M. Randomized, double-blind, crossover study to investigate the effect of rivaroxaban on QT-interval prolongation. Drug Saf 2008; 31 (1): 67–77.

    Article  PubMed  CAS  Google Scholar 

  28. Jiang J, Hu Y, Zhang J, et al. Safety, pharmacokinetics and pharmacodynamics of single doses of rivaroxaban — an oral, direct factor Xa inhibitor — in elderly Chinese subjects. Thromb Haemost 2010; 103 (1): 234–41.

    Article  PubMed  CAS  Google Scholar 

  29. Zhao X, Sun P, Zhou Y, et al. Safety, pharmacokinetics and pharmacodynamics of single/multiple doses of the oral, direct factor Xa inhibitor rivaroxaban in healthy Chinese subjects. Br J Clin Pharmacol 2009; 68 (1): 77–88.

    Article  PubMed  CAS  Google Scholar 

  30. Kubitza D, Becka M, Zuehlsdorf M, et al. Body weight has limited influence on the safety, tolerability, pharmacokinetics, or pharmacodynamics of rivaroxaban (BAY 59–7939) in healthy subjects. J Clin Pharmacol 2007 Feb. 47 (2): 218–26.

    Article  PubMed  CAS  Google Scholar 

  31. Kubitza D, Becka M, Zuehlsdorf M, et al. Effects of single-dose BAY 59–7939 -an oral, direct factor Xa inhibitor — in subjects with extreme body weight [abstract no. 1872]. Blood 2005 Nov 16; 106 (11): 532.

    Google Scholar 

  32. Kubitza D, Becka M, Mueck W, et al. Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct factor Xa inhibitor. Br J Clin Pharmacol 2010 Nov. 70 (5): 703–12.

    Article  PubMed  CAS  Google Scholar 

  33. Kubitza D, Becka M, Mueck W, et al. The effect of age and gender on the pharmacology and safety of the oral, direct factor Xa inhibitor rivaroxaban [abstract no. P-T-628]. 21st Congress of the International Society on Thrombosis and Haemostasis; 2007 Jul 6–12; Geneva.

  34. 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 (11): 271–2.

    Google Scholar 

  35. Janssen Pharmaceuticals Inc. Prescribing Information: xarelto (rivaroxaban) [online]. Available from URL: http://www.janssenpharmaceuticalsinc.com/assets/xareltopi.pdf [Accessed 2012 Jan 11].

  36. Center for Drug Evaluation and Research. Medical review of rivaroxaban (xareltoTM) [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022406Orig1s000MedR.pdf [Accessed 2011 Oct 25].

  37. Bayer Inc.. Xarelto® (rivaroxaban 10 mg tablets): product monograph [online]. Available from URL: http://www.bayer.ca/files/XARELTO-PM-ENG-14SEP2011-142438.pdf?# [Accessed 2012 Jan 11].

  38. 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 May. 46 (5): 549–58.

    Article  PubMed  CAS  Google Scholar 

  39. Moore TK, Plotinov AN, Thyssen A, et al. Effect of multiple doses of omeprazole on the pharmacokinetics, pharmacodynamics, and safety of a single dose of rivaroxaban. J Cardiovasc Pharmacol 2011. Epub.

  40. Lang D, Freudenberger C, Weinz C. In vitro metabolism of rivaroxaban, an oral, direct factor Xa inhibitor, in liver microsomes and hepatocytes of rats, dogs, and humans. Drug Metab Dispos 2009 Feb 5. 37 (5): 1046–55.

    Article  PubMed  CAS  Google Scholar 

  41. Weinz C, Schwarz T, Kubitza D, et al. Metabolism and excretion of rivaroxaban, an oral, direct factor Xa inhibitor, in rats, dogs, and humans. Drug Metab Dispos 2009 Feb 5. 37 (5): 1056–64.

    Article  PubMed  CAS  Google Scholar 

  42. 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 Jan. 4 (1): 121–8.

    Article  PubMed  CAS  Google Scholar 

  43. 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 Nov 28. 114 (22): 2374–81.

    Article  PubMed  CAS  Google Scholar 

  44. 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 Nov. 3 (11): 2479–86.

    Article  CAS  Google Scholar 

  45. Eriksson BI, Borris LC, Friedman RJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008 Jun 26. 358 (26): 2765–75.

    Article  PubMed  CAS  Google Scholar 

  46. Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008 Jun 26. 358 (26): 2776–86.

    Article  PubMed  CAS  Google Scholar 

  47. Turpie AG, Lassen MR, Davidson BL, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. Lancet 2009 May 16. 373 (9676): 1673–80.

    Article  PubMed  CAS  Google Scholar 

  48. Kakkar AK, Brenner B, Dahl OE, et al. 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 Jul 5; 372(9632): 31–9.

    Article  PubMed  CAS  Google Scholar 

  49. Eriksson BI, Kakkar AK, Turpie AG, et al. Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement. J Bone Joint Surg Br 2009 May. 91 (5): 636–44.

    Article  PubMed  CAS  Google Scholar 

  50. Eriksson BI, Turpie AG, Lassen MR, et al. A pooled analysis of four pivotal studies of rivaroxaban for the prevention of venous thromboembolism after orthopaedic surgery: effects of specified co-medications [abstract no. 1986]. 50th American Society of Hematology Annual Meeting and Exposition; 2008 Dec 6–9; San Fransisco (CA).

  51. Turpie AG, Lassen MR, Eriksson BI, et al. Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty: pooled analysis of four studies. Thromb Haemost 2011 Mar. 105 (3): 444–53.

    Article  PubMed  CAS  Google Scholar 

  52. Diamantopoulos A, Lees M, Wells PS, et al. Cost-effectiveness of rivaroxaban versus enoxaparin for the prevention of postsurgical venous thromboembolism in Canada. Thromb Haemost 2010 Oct. 104 (4): 760–70.

    Article  PubMed  CAS  Google Scholar 

  53. Duran A, Sengupta N, Diamantopoulos A, et al. Cost and outcomes associated with rivaroxaban vs enoxaparin for the prevention of postsurgical venous thromboembolism from a US payers perspective. J Med Econ 2011; 14(6): 824–34.

    Article  PubMed  Google Scholar 

  54. Nicolaides AN, Fareed J, Kakkar AK. Prevention and treatment of venous thromboembolism. International Consensus Statement (guidelines according to scientific evidence). Int Angiol 2006 Jun. 25 (2): 101–61.

    Google Scholar 

  55. Wells PS, Borah BJ, Sengupta N, et al. Analysis of venous thromboprophylaxis duration and outcomes in orthopedic patients. Am J Manag Care 2010 Nov; 16(11): 857–863.

    PubMed  Google Scholar 

  56. Qadan M, Polk HC Jr, Hohmann SF, et al. A reassessment of needs and practice patterns in pharmacologic prophylaxis of venous thromboembolism following elective major surgery. Ann Surg 2011 Feb. 253 (2): 215–20.

    Article  PubMed  Google Scholar 

  57. Reynolds NA, Perry CM, Scott LJ. Fondaparinux sodium: a review of its use in the prevention of venous thromboembolism following major orthopaedic surgery. Drugs 2004; 64 (14): 1575–96.

    Article  PubMed  CAS  Google Scholar 

  58. Mori S, Matsuura A, Rama Prasad YV, et al. Studies on the intestinal absorption of low molecular weight heparin using saturated fatty acids and their derivatives as an absorption enhancer in rats. Biol Pharm Bull 2004 Mar. 27 (3): 418–21.

    Article  PubMed  CAS  Google Scholar 

  59. Samama MM, Gerotziafas GT. Newer anticoagulants in 2009. J Thromb Thrombolysis 2010 Jan. 29 (1): 92–104.

    Article  PubMed  CAS  Google Scholar 

  60. European Medicines Agency (EMEA). European public assessment report. Pradaxa [online]. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000829/WC500041062.pdf [Accessed 2012 Jan 11].

  61. Boehringer Ingelheim Canada Ltd. PradaxTM (dabigatran etexilate capsules 75 mg and 110mg): product monograph [online]. Available from URL: http://www.boehringer-ingelheim.ca/content/dam/internet/opu/ca_EN/documents/humanhealth/product_monograph/Pradax-pm.pdf [Accessed 2012 Jan 11].

  62. Eriksson BI, Dahl OE, Rosencher N, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. [Published erratum appears in Lancet 2007 Dec 15; 370 (9604): 2004]. Lancet 2007 Sep 15. 370 (9591): 949–56.

    Article  CAS  Google Scholar 

  63. Eriksson BI, Dahl OE, Rosencher N, et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. Journal of Thrombosis & Haemostasis 2007 Nov. 5 (11): 2178–85.

    CAS  Google Scholar 

  64. RE-MOBILIZE Writing Committee, Ginsberg JS, Davidson BL, et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty 2009 Jan. 24 (1): 1–9.

    Article  PubMed  Google Scholar 

  65. Gross PL, Weitz JI. New anticoagulants for treatment of venous thromboembolism. Arterioscler Thromb Vasc Biol 2008 Mar. 28 (3): 380–6.

    Article  PubMed  CAS  Google Scholar 

  66. Carter NJ, McCormack PL, Plosker GL. Enoxaparin: a review of its use in ST-segment elevation myocardial infarction. Drugs 2008; 68 (5): 691–710.

    Article  PubMed  CAS  Google Scholar 

  67. Eerenberg ES, Kamphuisen PW, Sijpkens MK, et al. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation 2011. Epub.

  68. Fareed J, Ma Q, Florian M, et al. Differentiation of low-molecular-weight heparins: impact on the future of the management of thrombosis. Semin Thromb Hemost 2004 Feb; 30 Suppl 1: 89–104.

    PubMed  Google Scholar 

  69. Diamantopoulos A, LeReun C, Rasul F, et al. Indirect comparisons of rivaroxaban vs alternative prophylaxis for the prevention of venous thromboembolism in patients undergoing total hip or total knee replacement [abstract no. 1292]. 50th American Society of Hematology Annual Meeting and Exposition; 2008 Dec 6–9; San Fransisco (CA).

  70. Lereun C, Wells P, Diamantopoulos A, et al. An indirect comparison, via enoxaparin, of rivaroxaban with dabigatran in the prevention of venous thromboembolism after hip or knee replacement. J Med Econ 2011; 14 (2): 238–44.

    Article  PubMed  Google Scholar 

  71. Loke YK, Kwok CS. Dabigatran and rivaroxaban for prevention of venous thromboembolism: systematic review and adjusted indirect comparison. J Clin Pharm Ther 2011 Feb. 36 (1): 111–24.

    Article  PubMed  CAS  Google Scholar 

  72. Trkulja V, Kolundzic R. Rivaroxaban vs dabigatran for thromboprophylaxis after joint-replacement surgery: exploratory indirect comparison based on meta-analysis of pivotal clinical trials. Croat Med J 2010 Apr 15. 51 (2): 113–23.

    Article  PubMed  Google Scholar 

  73. Bayer. Xarelto regulatory post-marketing surveillance [ClinicalTrials.gov identifier NCT01029743]. US National Institutes of Health, Clinical Trials, gov [online]. Available from URL: http://www.clinicaltrials.gov [Accessed 2012 Jan 11].

Download references

Author information

Authors and Affiliations

  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand

    Sean T. Duggan

Authors
  1. Sean T. Duggan
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sean T. Duggan.

Additional information

Various sections of the manuscript reviewed by:

A. Diamantopoulos, Symmetron Limited, London, UK; A. Sasahara, Cardiovascular Division, Brigham & Women’s Hospital, Boston, MA, USA; C. Colwell, Scripps Clinic, Shiley Center for Orthopaedic Research and Education, La Jolla, CA, USA; J. Fareed, Department of Pathology, Loyola University Medical Center, Chicago, IL, USA; H. Rupprecht, Medizinische Klinik, GPR Klinikum RUsselsheim, RUsselsheim, Germany; T. M. Hyers, CARE Clinical Research, St. Louis, MO, USA.

Data Selection

Sources: Medical literature (including published and unpublished data) on ‘rivaroxaban’ in the prevention of venous thromboembolism in patients undergoing orthopedic surgery was identified by searching databases since 1996 (including MEDLINE and EMBASE and in-house AdisBase), bibliographies from published literature, clinical trial registries/databases and websites (including those of regional regulatory agencies and the manufacturer). Additional information (including contributory unpublished data) was also requested from the company developing the drug.

Search strategy: MEDLINE, EMBASE and AdisBase search terms were ‘rivaroxaban’ and ‘venous thromboembolism’ or ‘venous thromboembolism prevention’ and ‘orthopedic’ or ‘orthopaedic’ or ‘orthopaedic procedures’ or ‘arthroplasty’ or ‘surgery or knee’ or ‘hip’. Searches were last updated on 11 January 2012.

Selection: Studies for prevention of venous thromboembolism in patients undergoing orthopedic surgery who received rivaroxaban. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Rivaroxaban, venous thromboembolism, deep vein thrombosis, pulmonary embolism, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Duggan, S.T. Rivaroxaban. Am J Cardiovasc Drugs 12, 57–72 (2012). https://doi.org/10.2165/11208470-000000000-00000

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/11208470-000000000-00000

Keywords

Search

Navigation