Rivaroxaban as an oral anticoagulant for stroke prevention in atrial fibrillation

Therapeutics and Clinical Risk Management

Volumn 10, Issue 1, 2014, Pages 197-205

  Turpie, Alexander G G ^a  

^a MCMASTER UNIVERSITY   (Canada)

Author keywords

Anticoagulation; Atrial fibrillation; Rivaroxaban; Stroke

Indexed keywords

RIVAROXABAN; VITAMIN K GROUP; WARFARIN;

BLEEDING; CEREBROVASCULAR ACCIDENT; CLINICAL PRACTICE; DEEP VEIN THROMBOSIS; EMBOLISM PREVENTION; HEART ATRIUM FIBRILLATION; HUMAN; MODERATE RENAL IMPAIRMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; REVIEW; THROMBOSIS; TRANSIENT ISCHEMIC ATTACK; VEIN EMBOLISM;

EID: 84896977808     PISSN: 11766336     EISSN: 1178203X     Source Type: Journal    
DOI: 10.2147/TCRM.S30159     Document Type: Review

References (55)

1. Perzborn E, Roehrig S, Straub A, Kubitza D, Misselwitz F. The discovery and development of rivaroxaban, an oral, direct Factor Xa inhibitor. Nat Rev Drug Discov. 2011;10(1):61-75.
2. Bayer Pharma AG. Xarelto® (rivaroxaban) Summary of Product Characteristics. Leverkusen, Germany: Bayer Pharma AG; 2013. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108.pdf. Accessed August 13, 2013.
3. Janssen Pharmaceuticals, Inc. Xarelto® (rivaroxaban) Full Prescribing Information. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2011. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s001lbl.pdf. Accessed February 22, 2013.
4. Patel MR, Mahaffey KW, Garg J, et al; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-891.
5. Lloyd-Jones DM, Wang TJ, Leip EP, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004;110(9):1042-1046.
6. Camm AJ, Lip GYH, De Caterina R, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012;33(21):2719-2747.
7. Barco S, Cheung YM, Eikelboom JW, Coppens M. New oral anticoagulants in elderly patients. Best Pract Res Clin Haematol. 2013;26(2): 215-224.
8. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991;22(8):983-988.
9. Steger C, Pratter A, Martinek-Bregel M, et al. Stroke patients with atrial fibrillation have a worse prognosis than patients without: data from the Austrian Stroke registry. Eur Heart J. 2004;25(19):1734-1740.
10. Marini C, De Santis F, Sacco S, et al. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005;36(6):1115-1119.
11. Gladstone DJ, Bui E, Fang J, et al. Potentially preventable strokes in high-risk patients with atrial fibrillation who are not adequately anticoagulated. Stroke. 2009;40(1):235-240.
12. Makaryus JN, Halperin JL, Lau JF. Oral anticoagulants in the management of venous thromboembolism. Nat Rev Cardiol. 2013;10(7):397-409.
13. Ageno W, Gallus AS, Wittkowsky A, Crowther M, Hylek EM, Palareti G. American College of Chest Physicians. Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(Suppl 2):e44S-e88S.
14. Mercury Pharmaceuticals Ltd. Warfarin 0.5 mg tablets Summary of Product Characteristics. Surrey, UK: Mercury Pharmaceuticals Ltd.; 2013. Available from: http://www.medicines.org.uk/EMC/medicine/25626/SPC/Warfarin+0.5mg+Tablets. Accessed February 5, 2014.
15. You JJ, Singer DE, Howard PA, et al. American College of Chest Physicians. Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(Suppl 2):e531S-e575S.
16. Mahlmann A, Gehrisch S, Beyer-Westendorf J. Pharmacokinetics of rivaroxaban after bariatric surgery: a case report. J Thromb Thrombolysis. 2013;36(4):533-535.
17. Kubitza D, Becka M, Voith B, Zuehlsdorf M, Wensing G. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct Factor Xa inhibitor. Clin Pharmacol Ther. 2005;78(4):412-421.
18. 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(12):873-880.
19. Turpie AG, Kreutz R, Llau J, Norrving B, Haas S. Management consensus guidance for the use of rivaroxaban-an oral, direct Factor Xa inhibitor. Thromb Haemost. 2012;108(5):876-886.
20. Kubitza D, Becka M, Roth A, Mueck W. Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects. Curr Med Res Opin. 2008;24(10):2757-2765.
21. 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):203-216.
22. 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;100(3):453-461.
23. Mueck W, Lensing AW, Agnelli G, Decousus H, Prandoni P, Misselwitz F. Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention. Clin Pharmacokinet. 2011;50(10):675-686.
24. Agnelli G, Gallus A, Goldhaber SZ, et al; ODIXa-DVT Study Investigators. Treatment of proximal deep-vein thrombosis with the oral direct Factor Xa inhibitor rivaroxaban (BAY 59-7939): the ODIXa-DVT (Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients With Acute Symptomatic Deep-Vein Thrombosis) study. Circulation. 2007;116(2):180-187.
25. Kreutz R. Pharmacodynamic and pharmacokinetic basics of rivaroxaban. Fundam Clin Pharmacol. 2012;26(1):27-32.
26. Fox KA, Piccini JP, Wojdyla D, et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J. 2011;32(19):2387-2394.
27. Hankey GJ, Patel MR, Stevens SR, et al; ROCKET AF Steering Committee Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012;11(4):315-322.
28. Buller HR, Lensing AW, Prins MH, et al; Einstein-DVT Dose-Ranging Study investigators. A dose-ranging study evaluating once-daily oral administration of the Factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study. Blood. 2008;112(6):2242-2247.
29. Halperin JL, Wojdyla D, Piccini JP, Lokhnygina Y, Patel MR, Breinhardt G. Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the ROCKET-AF trial. Stroke. 2012;43(2_Meeting Abstracts):A148.
30. van Diepen S, Hellkamp AS, Patel MR, et al. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013;6(4):740-747.
31. Mahaffey KW, Wojdyla D, Hankey GJ, et al. Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial. Ann Intern Med. 2013;158(12):861-868.
32. Mahaffey KW, White HD, Nessel CC, et al. Ischemic cardiac outcomes in patients with AF treated with vitamin K antagonism or Factor Xa inhibition: results from the ROCKET AF trial. Circulation. 2011;124 (Suppl.):Abstract 13482.
33. Hori M, Matsumoto M, Tanahashi N, et al; J-ROCKET AF study investigators. Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation-the J-ROCKET AF study. Circ J. 2012;76(9): 2104-2111.
34. Bayer. Xarelto for prevention of stroke in patients with atrial fibrillation (XANTUS). Available from: http://clinicaltrials.gov/show/NCT01606995. NLM identifier: NCT010606995. Accessed January 8, 2014.
35. Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation. 2011;124(14):1573-1579.
36. Perzborn E, Gruber A, Tinel H, et al. Reversal of rivaroxaban anticoagulation by haemostatic agents in rats and primates. Thromb Haemost. 2013;110(1):162-172.
37. Godier A, Miclot A, Le Bonniec B, et al. Evaluation of prothrombin complex concentrate and recombinant activated Factor VII to reverse rivaroxaban in a rabbit model. Anesthesiology. 2012;116(1):94-102.
38. Kaatz S, Kouides PA, Garcia DA, et al. Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors. Am J Hematol. 2012;87 Suppl 1:S141-S145.
39. Lu G, DeGuzman FR, Hollenbach SJ, et al. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation Factor Xa. Nat Med. 2013;19(4):446-451.
40. Portola Pharmaceuticals. Phase 2 healthy volunteer study to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. Available from: http://clinicaltrials.gov/ct2/show/NCT01758432?term=NCT01758432&rank=1. NLM identifier: NCT01758432. Accessed January 8, 2014.
41. Johann Wolfgang Goethe University Hospitals. Reversal agent use in patients treated with direct oral anticoagulants (RADOA). Available from: http://clinicaltrials.gov/ct2/show/NCT01722786?term=NCT01722786&rank=1. NLM identifier: NCT01722786. Accessed February 5, 2014.
42. Gerotziafas GT, Baccouche H, Sassi M, et al. Optimisation of the assays for the measurement of clotting factor activity in the presence of rivaroxaban. Thromb Res. 2012;129(1):101-103.
43. Mani H, Hesse C, Stratmann G, Lindhoff-Last E. Rivaroxaban differentially influences ex vivo global coagulation assays based on the administration time. Thromb Haemost. 2011;106(1):156-164.
44. Asmis LM, Alberio L, Angelillo-Scherrer A, et al. Rivaroxaban: quantification by anti-FXa assay and influence on coagulation tests: a study in 9 Swiss laboratories. Thromb Res. 2012;129(4):492-498.
45. Freyburger G, Macouillard G, Labrouche S, Sztark F. Coagulation parameters in patients receiving dabigatran etexilate or rivaroxaban: two observational studies in patients undergoing total hip or total knee replacement. Thromb Res. 2011;127(5):457-465.
46. Harenberg J, Erdle S, Marx S, Krämer R. Determination of rivaroxaban in human plasma samples. Semin Thromb Hemost. 2012;38(2):178-184.
47. Hillarp A, Baghaei F, Fagerberg Blixter I, et al. Effects of the oral, direct factor Xa inhibitor rivaroxaban on commonly used coagulation assays. J Thromb Haemost. 2011;9(1):133-139.
48. Mani H, Rohde G, Stratmann G, et al. Accurate determination of rivaroxaban levels requires different calibrator sets but not addition of antithrombin. Thromb Haemost. 2012;108(1):191-198.
49. Samama MM, Contant G, Spiro TE, et al. Rivaroxaban Prothrombin Time Field Trial Laboratories. Evaluation of the prothrombin time for measuring rivaroxaban plasma concentrations using calibrators and controls: results of a multicenter field trial. Clin Appl Thromb Hemost. 2012;18(2):150-158.
50. Kakkar AK, Mueller I, Bassand JP, et al; GARFIELD Registry Investigators. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One. 2013;8(5):e63479.
51. Boehringer Ingelheim Pharmaceuticals Inc. Pradaxa® (dabigatran etexilate) Prescribing Information. 2013. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022512s017lbl.pdf. Accessed January 28, 2014.
52. Boehringer Ingelheim International GmbH. Pradaxa® (dabigatran etexilate) Summary of Product Characteristics. 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000829/WC500041059.pdf. Accessed January 28, 2014.
53. Bristol-Myers Squibb Company, Pfizer Inc. Eliquis® (apixaban) Prescribing Information. 2012. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202155s000lbl.pdf. Accessed January 28, 2014.
54. Bristol-Myers Squibb, Pfizer EEIG. Eliquis® (apixaban) Summary of Product Characteristics. 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf. Accessed January 28, 2014.
55. Samama MM, Martinoli JL, Le Flem L, et al. Assessment of laboratory assays to measure rivaroxaban-an oral, direct Factor Xa inhibitor. Thromb Haemost. 2010;103(4):815-825.