Skip to main content
Log in

Evaluating the efficacy and safety of apixaban, a new oral anticoagulant, using Bayesian meta-analysis

  • Review Article
  • Published:
International Journal of Hematology Aims and scope Submit manuscript

Abstract

Apixaban is a direct inhibitor of factor Xa, and is a potential alternative for the treatment of acute venous thromboembolism. This study sought to evaluate the efficacy and safety of apixaban versus enoxaparin. A systematic search of the literature for randomized controlled trials of apixaban thromboprophylaxis versus enoxaparin was conducted using three databases: PubMed, EMBASE, and the Cochrane library. Five studies that included a total of 12,938 patients were analyzed using Bayesian random-effects meta-analysis. To evaluate efficacy, a composite of venous thromboembolism and death during follow-up was measured. To evaluate safety, major and total bleeding events were considered. The odds ratio (OR) for the composite outcome of efficacy was 0.66 (95 % CI 0.33–1.29) for apixaban compared to enoxaparin, while there was a similar risk of major bleeding (OR 1.03, 95 % CI 0.36–3.73) and total bleeding (OR 0.92, 95 % CI 0.64–1.20). These results suggest a lack of clear superiority of apixaban relative to enoxaparin. Apixaban is an oral alternative with similar efficacy and safety to existing anticoagulant therapies.

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

Access this article

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

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Mavrakanas T, Bounameaux H. The potential role of new oral anticoagulants in the prevention and treatment of thromboembolism. Pharmacol Ther. 2011;130:46–58.

    Article  PubMed  CAS  Google Scholar 

  2. Galanis T, Thomson L, Palladino M, Merli GJ. New oral anticoagulants. J Thromb Thrombolysis. 2011;31:310–20.

    Article  PubMed  CAS  Google Scholar 

  3. Steffel J, Braunwald E. Novel oral anticoagulants: focus on stroke prevention and treatment of venous thrombo-embolism. Eur Heart J. 2011;32:1968–76.

    Article  PubMed  CAS  Google Scholar 

  4. De Caterina R, Husted S, Wallentin L, Agnelli G, Bachmann F, Baigent C, et al. Anticoagulants in heart disease: current status and perspectives. Eur Heart J. 2007;28:880–913.

    Article  PubMed  Google Scholar 

  5. Chisholm-Burns MA. Pharmacotherapy principles & practice. 2nd ed. New York: McGraw-Hill; 2010.

    Google Scholar 

  6. Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med. 2010;363:2487–98.

    Article  PubMed  CAS  Google Scholar 

  7. Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med. 2009;361:594–604.

    Article  PubMed  CAS  Google Scholar 

  8. Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010;375:807–15.

    Article  PubMed  CAS  Google Scholar 

  9. Samama CM. New anticoagulants: pharmacology and clinical studies. Wien Med Wochenschr. 2011;161:54–7.

    Article  PubMed  Google Scholar 

  10. Davis EM, Packard KA, Knezevich JT, Campbell JA. New and emerging anticoagulant therapy for atrial fibrillation and acute coronary syndrome. Pharmacotherapy. 2011;31:975–1016.

    Article  PubMed  CAS  Google Scholar 

  11. Martin MT, Nutescu EA. Therapeutic potential of apixaban in the prevention of venous thromboembolism in patients undergoing total knee replacement surgery. Curr Med Res Opin. 2011;27:2123–31.

    Article  PubMed  CAS  Google Scholar 

  12. Frost C, Nepal S, Wang J, Schuster A, Byon W, Boyd RA, et al. Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects. Br J Clin Pharmacol. 2013. doi:10.1111/bcp.12106

  13. Bush S, LeClaire A, Hampp C, Lottenberg L. Review of a large clinical series: once- versus twice-daily enoxaparin for venous thromboembolism prophylaxis in high-risk trauma patients. J Intensive Care Med. 2011;26:111–5.

    Article  PubMed  Google Scholar 

  14. Hebbeler SL, Marciniak CM, Crandall S, Chen D, Nussbaum S, Mendelewski S. Daily vs twice daily enoxaparin in the prevention of venous thromboembolic disorders during rehabilitation following acute spinal cord injury. J Spinal Cord Med. 2004;27:236–40.

    PubMed  Google Scholar 

  15. Spiro TE, Johnson GJ, Christie MJ, Lyons RM, MacFarlane DE, Blasier RB, et al. Efficacy and safety of enoxaparin to prevent deep venous thrombosis after hip replacement surgery. Enoxaparin Clinical Trial Group. Ann Intern Med. 1994;121:81–9.

    Article  PubMed  CAS  Google Scholar 

  16. Falck-Ytter Y, Francis CW, Johanson NA, Curley C, Dahl OE, Schulman S, et al. Prevention of VTE in orthopedic surgery patients: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141:278S–325S.

    Article  Google Scholar 

  17. Schulman S, Kearon C. Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005;3:692–4.

    Article  PubMed  CAS  Google Scholar 

  18. Spiegelhalter DJ, Abrams KR, Myles JP. Bayesian approaches to clinical trials and health-care evaluation. Chichester: Wiley; 2004. p. 105–11.

    Google Scholar 

  19. Lunn DJ, Thomas A, Best N, Spiegelhalter D. WinBUGS—a Bayesian modelling framework: concepts, structure, and extensibility. Stat Comput. 2000;10:325–37.

    Article  Google Scholar 

  20. Hirsh J, Bauer KA, Donati MB, Gould M, Samama MM, Weitz JI. Parenteral anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest. 2008;133:141S–59S.

    Article  PubMed  CAS  Google Scholar 

  21. Werth S, Halbritter K, Beyer-Westendorf J. Efficacy and safety of venous thromboembolism prophylaxis with apixaban in major orthopedic surgery. Ther Clin Risk Manag. 2012;8:139–47.

    PubMed  CAS  Google Scholar 

  22. Frost C, Wang J, Nepal S, Schuster A, Barrett YC, Mosqueda-Garcia R, et al. Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. Br J Clin Pharmacol. 2013;75:476–87.

    Article  PubMed  CAS  Google Scholar 

  23. Lassen MR, Davidson BL, Gallus A, Pineo G, Ansell J, Deitchman D. The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement. J Thromb Haemost. 2007;5:2368–75.

    Article  PubMed  CAS  Google Scholar 

  24. Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, et al. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011;365:2167–77.

    Article  PubMed  CAS  Google Scholar 

  25. Huang J, Cao Y, Liao C, Wu L, Gao F. Apixaban versus enoxaparin in patients with total knee arthroplasty. A meta-analysis of randomised trials. Thromb Haemost. 2011;105:245–53.

    Article  PubMed  CAS  Google Scholar 

Download references

Conflict of interest

The authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Lorenzo A. Villa.

About this article

Cite this article

Villa, L.A., Malone, D.C. & Ross, D. Evaluating the efficacy and safety of apixaban, a new oral anticoagulant, using Bayesian meta-analysis. Int J Hematol 98, 390–397 (2013). https://doi.org/10.1007/s12185-013-1445-2

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12185-013-1445-2

Keywords

Navigation