The role of apixaban for venous and arterial thromboembolic disease;El papel de apixaban en la enfermedad tromboembólica venosa y arterial

Annals of Pharmacotherapy

Volumn 45, Issue 10, 2011, Pages 1262-1283

  Prom, Rathasen ^a   Spinler, Sarah A ^a  

^a UNIVERSITY OF THE SCIENCES   (United States)

Author keywords

Acute coronary syndrome; Anticoagulant; Apixaban; Atrial fibrillation; Factor xa inhibitor; Venous thromboembolism

Indexed keywords

ACETYLSALICYLIC ACID; ANTIVITAMIN K; APIXABAN; ATENOLOL; BMS 562247 01; CLOPIDOGREL; DABIGATRAN; DIGOXIN; DILTIAZEM; ENOXAPARIN; FAMOTIDINE; FONDAPARINUX; HEPARIN; KETOCONAZOLE; LOW MOLECULAR WEIGHT HEPARIN; NAPROXEN; OMEPRAZOLE; PLACEBO; RIFAMPICIN; RIVAROXABAN; TAMOXIFEN; UNCLASSIFIED DRUG; WARFARIN;

ACUTE CORONARY SYNDROME; BLEEDING; BRAIN HEMORRHAGE; DEEP VEIN THROMBOSIS; DRUG DOSE COMPARISON; HEART ATRIUM ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HUMAN; LUNG EMBOLISM; PRIORITY JOURNAL; REVIEW; SINGLE DRUG DOSE; STROKE; THROMBOEMBOLISM; TOTAL HIP PROSTHESIS; TOTAL KNEE REPLACEMENT; VENOUS THROMBOEMBOLISM;

ADULT; ANTICOAGULANTS; ARTHROPLASTY, REPLACEMENT, HIP; ARTHROPLASTY, REPLACEMENT, KNEE; CLINICAL TRIALS AS TOPIC; DRUG INTERACTIONS; FACTOR XA; HUMANS; PULMONARY EMBOLISM; PYRAZOLES; PYRIDONES; THROMBOEMBOLISM; VENOUS THROMBOEMBOLISM;

EID: 80053999859     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1Q119     Document Type: Review

References (70)

1. Baetz BE, Spinler SA. Dabigatran etexilate: an oral direct thrombin inhibitor for prophylaxis and treatment of thromboembolic diseases. Pharmacotherapy 2008;28:1354-73.
2. Stroke prevention in atrial fibrillation study. Final results. Circulation 1991;84:527-39.
3. The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. N Engl J Med 1990;323:1505-11.
4. Petersen P, Boysen G, Godtfredsen J, Andersen ED, Andersen B. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet 1989;1:175-9.
5. Connolly SJ, Laupacis A, Gent M, Roberts RS, Cairns JA, Joyner C. Canadian Atrial Fibrillation Anticoagulation (CAFA) Study. J Am Coll Cardiol 1991;18:349-55.
6. Ezekowitz MD, Bridgers SL, James KE, et al. Warfarin in the prevention of stroke associated with nonrheumatic atrial fibrillation. Veterans Affairs Stroke Prevention in Nonrheumatic Atrial Fibrillation Investigators. N Engl J Med 1992;327:1406-12.
7. Anand SS, Yusuf S. Oral anticoagulants in patients with coronary artery disease. J Am Coll Cardiol 2003;41:62S-9S.
8. Anand SS, Yusuf S. Oral anticoagulant therapy in patients with coronary artery disease: a meta-analysis. JAMA 1999;282:2058-67.
9. Rothberg MB, Celestin C, Fiore LD, Lawler E, Cook JR. Warfarin plus aspirin after myocardial infarction or the acute coronary syndrome: metaanalysis with estimates of risk and benefit. Ann Intern Med 2005;143: 241-50.
10. Andreotti F, Testa L, Biondi-Zoccai GG, Crea F. Aspirin plus warfarin compared to aspirin alone after acute coronary syndromes: an updated and comprehensive meta-analysis of 25,307 patients. Eur Heart J 2006; 27:519-26.
11. Salem DN, O'Gara PT, Madias C, Pauker SG. Valvular and structural heart disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008;133:593S-629S.
12. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008;133:454S-545S.
13. 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;133:381S-453S.
14. FDA approves Xarelto to reduce risk of blood clots after hip, knee replacements. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm261839.htm (accessed 2011 Sep 1).
15. 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.
16. 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.
17. 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.
18. Buller H, Deitchman D, Prins M, Segers A. Efficacy and safety of the oral direct factor Xa inhibitor apixaban for symptomatic deep vein thrombosis. The Botticelli DVT dose-ranging study. J Thromb Haemost 2008;6:1313-8.
19. Alexander JH, Becker RC, Bhatt DL, et al. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation 2009;119:2877-85.
20. Ufer M. Comparative efficacy and safety of the novel oral anticoagulants dabigatran, rivaroxaban and apixaban in preclinical and clinical development. Thromb Haemost 2010;103:572-85.
21. APPRAISE-2 study with investigational compound apixaban in acute coronary syndrome discontinued. http://www.businesswire.com/news/home/ 20101118007161/en/APPRAISE-2-Study-Investigational-Compound-Apixaban-Acute-Coronary (accessed 2010 Feb 4).
22. Wong PC, Pinto DJ, Zhang D. Preclinical discovery of apixaban, a direct and orally bioavailable factor Xa inhibitor. J Thromb Thrombolysis 2011; 31:478-92.
23. Adams RL, Bird RJ. Coagulation cascade and therapeutics update: relevance to nephrology. Part 1: overview of coagulation, thrombophilias and history of anticoagulants. Nephrology (Carlton) 2009;14:462-70.
24. 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.
25. Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008;133:160S-98S.
26. Wong PC, Crain EJ, Xin B, et al. Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies. J Thromb Haemost 2008;6:820-9.
27. Wong PC, Jiang X. Apixaban, a direct factor Xa inhibitor, inhibits tissuefactor induced human platelet aggregation in vitro: comparison with direct inhibitors of factor VIIa, XIa and thrombin. Thromb Haemost 2010;104:302-10.
28. Raghavan N, Frost CE, Yu Z, et al. Apixaban metabolism and pharmacokinetics after oral administration to humans. Drug Metab Dispos 2009;37:74-81.
29. Eriksson BI, Quinlan DJ, Weitz JI. Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor Xa inhibitors in development. Clin Pharmacokinet 2009;48:1-22.
30. ELIQUIS prescribing information. http://www.eliquis.com/PDF/ELIQUIS %20%C2%AE%20(apixaban)%20SmPC.pdf (accessed 2011 May 23).
31. Vakkalagadda B, Frost C, Wang J, et al. Effect of rifampin on the pharmacokinetics of apixaban, an oral direct inhibitor of factor Xa (abstract 143). J Clin Pharmacol 2009;49:1124
32. Frost C, Wang J, Nepal S, et al. Effect of ketoconazole and diltiazem on the pharmacokinetics of apixaban, an oral direct factor Xa inhibitor (abstract 139). J Clin Pharmacol 2009;49:1123.
33. Frost C, Yu Z, Moore K, et al. Apixaban, an oral direct factor Xa inhibitor: multiple-dose safety, pharmacokinetics, and pharmacodynamics in healthy subjects. J Thromb Haemost 2007;5:P-M-664.
34. Perzborn E, Tersteegen A, Harwardt M, Lange U. Different characteristics of direct factor Xa inhibitors: in vitro comparative studies of rivaroxaban and apixaban. Blood (ASH Annual Meeting Abstracts) 2009;114: 4170.
35. Wang L, Zhang D, Raghavan N, et al. In vitro assessment of metabolic drug-drug interaction potential of apixaban through cytochrome P450 phenotyping, inhibition, and induction studies. Drug Metab Dispos 2010; 38:448-58.
36. Upreti V, Wang J, Barrett Y, et al. Effect of body weight on the pharmacokinetics of apixaban, an oral direct factor Xa inhibitor, in healthy subjects (abstract 16). J Clin Pharmacol 2010;50:1060.
37. Song Y, Cui Y, Li T, et al. Apixaban pharmacokinetics and pharmacodynamics in healthy Chinese subjects (abstract 22). J Clin Pharmacol 2010; 50:1062.
38. Frost C, Nepal S, Barrett Y, LaCreta F. Effects of age and gender on the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) of apixaban (abstract PP-MO-407). J Thromb Haemost 2009;7:455.
39. Wong PC, Crain EJ, Watson CA. Evaluation of clotting time assays for monitoring antithrombotic activities of the factor Xa inhibitors, apixaban and rivaroxaban, and the thrombin inhibitor dabigatran in the rabbit (abstract PP-TH-171). J Thromb Haemost 2009;7:991.
40. Barrett YC, Wang Z, Frost C, Shenker A. Clinical laboratory measurement of direct factor Xa inhibitors: anti-Xa assay is preferable to prothrombin time assay. Thromb Haemost 2010;104:1263-71.
41. HepTest. http://www.american-diagnostica.de/fileadmin/user_upload/ datasheets/830.pdf (accessed 2011 Apr 8).
42. Becker RC, Yang H, Barrett Y, et al. Chromogenic laboratory assays to measure the factor Xa-inhibiting properties of apixaban-an oral, direct and selective factor Xa inhibitor. J Thromb Thrombolysis 2011;32:183-7.
43. 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.
44. Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011;364:806-17.
45. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981-92.
46. Alexander JH, Lopes RD, James S, et al. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med 2011;365:699-708.
47. Study of apixaban for the prevention of thrombosis-related events in patients with acute medical illness (ADOPT). http://clinicaltrials.gov/ct2/ show/NCT00457002 (accessed 2011 Feb 11).
48. Efficacy and safety study of apixaban for extended treatment of deep vein thrombosis or pulmonary embolism. http://www.clinicaltrials.gov/ ct2/show/NCT00633893?term=apixaban&rank=10 (accessed 2011 Feb 11).
49. Efficacy and safety study of apixaban for the treatment of deep vein thrombosis or pulmonary embolism. http://clinicaltrials.gov/ct2/show/ NCT00643201?term=apixaban&rank=6 (accessed 2011 Feb 11).
50. ELIQUIS (apixaban) approved in Europe for preventing venous thromboembolism after elective hip or knee replacement. http://www.bms. com/news/press_releases/pages/default.aspx (accessed 2011 May 26).
51. Lopes RD, Alexander JH, Al-Khatib SM, et al. Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation (ARISTOTLE) trial: design and rationale. Am Heart J 2010;159:331-9.
52. A study to evaluate the safety of apixaban in acute coronary syndrome (ACS) Japanese patients. http://www.clinicaltrials.gov/ct2/show/ NCT00852397?term=apixaban&rank=9 (accessed 2011 Sep 1).
53. Masood S, Cunanan J, Hoppensteadt D, Van Thiel D, Fareed J. Drug interactions of oral antithrombin and anti-Xa agents with heparinized and oral anticoagulant treated patients (abstract PP-TH-142). J Thromb Haemost 2009;7:980.
54. Frost C, Lee L, Lee LY, Nepal S, Shenker A, Reeves RA. Apixaban does not affect the pharmacokinetics of digoxin (abstract 60). J Clin Pharmacol 2007;47:1196.
55. Mao Q, Unadkat JD. Role of the breast cancer resistance protein (ABCG2) in drug transport. AAPS J 2005;7:E118-33.
56. Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008; 358:2776-86.
57. Eriksson BI, Borris LC, Friedman RJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008;358:2765-75.
58. 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;372:31-9.
59. Turpie AG, Lassen MR, Davidson BL, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009;373:1673-80.
60. 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. Lancet 2007; 370:949-56.
61. 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. J Thromb Haemost 2007;5:2178-85.
62. Ginsberg JS, Davidson BL, Comp PC, et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty 2009;24:1-9.
63. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51.
64. Patel MR, Mahaffey KW, Gar JJ, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883-91.
65. Schulman S, Kearon C, Kakkar AK, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009; 361:2342-52.
66. Bauersachs R, Berkowitz SD, Brenner B, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499-510.
67. Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic pulmonary embolism with or without symptomatic deep-vein thrombosis: Einstein-PE evaluation. http://clinicaltrials.gov/ct2/show/ NCT00439777 (accessed 2011 Jan 17).
68. An efficacy and safety study for rivaroxaban in patients with acute coronary syndrome. http://www.clinicaltrials.gov/ct2/show/NCT00809965? term=rivaroxaban&rank=4 (accessed 2011 Feb 10).
69. RE-DEEM dose finding study for dabigatran etexilate in patients with acute coronary syndrome. http://www.clinicaltrials.gov/ct2/show/NCT00621855? term=dabigatran&rank=13 (accessed 2011 Feb 11).
70. Product Information. Pradaxa (dabigatran etexilate). Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, October 2010.