Anticoagulant prevention in patients with atrial fibrillation: Alternatives to vitamin K antagonists

Current Pharmaceutical Design

Volumn 19, Issue 21, 2013, Pages 3816-3826

  Kozlowski, Dariusz ^a   Budrejko, Szymon ^a   Raczak, Grzegorz ^a   Rysz, Jacek ^b   Banach, Maciej ^b  

^a MEDICAL UNIVERSITY OF GDANSK   (Poland)

^b MEDICAL UNIVERSITY OF LODZ   (Poland)

Author keywords

Anticoagulation; Apixaban; Atrial fibrillation; Dabigatran; Edoxaban; Rivaroxaban; Warfarin; Ximelagatran

Indexed keywords

ACETYLSALICYLIC ACID; ANTIVITAMIN K; APIXABAN; ATECEGATRAN METOXIL; BLOOD CLOTTING FACTOR 10A INHIBITOR; CLOPIDOGREL; DABIGATRAN; DABIGATRAN ETEXILATE; EDOXABAN; NEW DRUG; RIVAROXABAN; THROMBIN INHIBITOR; WARFARIN; XIMELAGATRAN;

ANTICOAGULANT THERAPY; ARTICLE; BLEEDING; CARDIOVERSION; CEREBROVASCULAR ACCIDENT; CREATININE BLOOD LEVEL; DEEP VEIN THROMBOSIS; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; EDEMA; EMBOLISM; FATIGUE; FOOD DRUG INTERACTION; GASTROINTESTINAL DISEASE; HEADACHE; HEART ATRIUM FIBRILLATION; HUMAN; HYPERTRANSAMINASEMIA; INFECTION; LIVER FAILURE; LIVER FUNCTION TEST; LIVER TOXICITY; NAUSEA; NONVALVULAR ATRIAL FIBRILLATION; PATIENT MONITORING; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR; SIDE EFFECT; THROMBOEMBOLISM; VENOUS THROMBOEMBOLISM; VOMITING;

ANTICOAGULANTS; ATRIAL FIBRILLATION; DRUG DESIGN; DRUG MONITORING; HEMORRHAGE; HUMANS; RISK FACTORS; STROKE; THROMBOEMBOLISM; VITAMIN K; WARFARIN;

EID: 84878637354     PISSN: 13816128     EISSN: 18734286     Source Type: Journal    
DOI: 10.2174/1381612811319210007     Document Type: Article

References (70)

1. Kozlowski D, Budrejko S, Lip GY, et al. Dronedarone: an overview. Ann Med 2012; 44: 60-72.
2. Kozlowski D, Budrejko S, Lip GY, et al. Lone atrial fibrillation: what do we know? Heart 2010; 96: 498-503.
3. Piotrowski G, Banach M, Gerdts E, et al. Left atrial size in hypertension and stroke. J Hypertens 2011; 29: 1988-93.
4. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991; 22: 983-8.
5. Piotrowski G, Szymałski P, Banach M, et al. Left atrial and left atrial appendage systolic function in patients with post-myocardial distal blocks. Arch Med Sci 2010; 6: 892-9.
6. Lin HJ, Wolf PA, Kelly-Hayes M, et al. Stroke severity in atrial fibrillation. The Framingham Study. Stroke 1996; 27: 1760-4.
7. Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001; 285: 2370-5.
8. Banach M, Kourliouros A, Reinhart KM, et al. Postoperative atrial fibrillation-what do we really know? Curr Vasc Pharmacol 2010; 8: 553-72.
9. Kozlowski D, Budrejko S, Lip GY, et al. Vernakalant hydrochloride for the treatment of atrial fibrillation. Expert Opin Investig Drugs 2009; 18: 1929-37.
10. European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery, Camm AJ, Kirchhof P, Lip GY, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J 2010; 31: 2369-429.
11. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007; 146: 857-67.
12. Lip GY, Edwards SJ. Stroke prevention with aspirin, warfarin and ximelagatran in patients with non-valvular atrial fibrillation: a systematic review and meta-analysis. Thromb Res 2006; 118: 321-33.
13. Riva N, Lip GY. A new era for anticoagulation in atrial fibrillation. Which anticoagulant should we choose for longterm prevention of thromboembolic complications in patients with atrial fibrillation? Pol Arch Med Wewn 2012; 122: 45-53.
14. Olsson SB, Executive Steering Committee of the SIIII. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial. Lancet 2003; 362: 1691-8.
15. Albers GW, Diener HC, Frison L, et al.; SPORTIF Executive Steering Committee for the SPORTIF V Investigators. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. JAMA 2005; 293: 690-8.
16. Lee WM, Larrey D, Olsson R, et al. Hepatic findings in long-term clinical trials of ximelagatran. Drug Saf 2005; 28: 351-70.
17. Stangier J, Rathgen K, Stahle H, Gansser D, Roth W. The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol 2007; 64: 292-303.
18. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet 2008; 47: 285-95.
19. Stangier J, Clemens A. Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor. Clin Appl Thromb Hemost 2009; 15 Suppl 1: 9S-16S.
20. Ezekowitz MD, Reilly PA, et al. Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO Study). Am J Cardiol 2007; 100: 1419-26.
21. Connolly SJ, Ezekowitz MD, Yusuf S, et al.; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-51.
22. Uchino K, Hernandez AV. Dabigatran association with higher risk of acute coronary events: meta-analysis of noninferiority randomized controlled trials. Arch Intern Med 2012; 172: 397-402.
23. Hohnloser SH, Oldgren J, Yang S, et al. Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial. Circulation 2012; 125: 669-76.
24. Liesenfeld KH, Lehr T, Dansirikul C, et al. Population pharmacokinetic analysis of the oral thrombin inhibitor dabigatran etexilate in patients with non-valvular atrial fibrillation from the RE-LY trial. J Thromb Haemost 2011; 9: 2168-75.
25. Flaker G, Ezekowitz M, Yusuf S, et al. Efficacy and safety of dabigatran compared to warfarin in patients with paroxysmal, persistent, and permanent atrial fibrillation: results from the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) study. J Am Coll Cardiol 2012; 59: 854-5.
26. Ezekowitz MD, Wallentin L, Connolly SJ, et al.; RE-LY Steering Committee and Investigators. Dabigatran and warfarin in vitamin K antagonist-naive and-experienced cohorts with atrial fibrillation. Circulation 2010; 122: 2246-53.
27. Oldgren J, Alings M, Darius H, et al.; RE-LY Investigators. Risks for stroke, bleeding, and death in patients with atrial fibrillation receiving dabigatran or warfarin in relation to the CHADS2 score: a subgroup analysis of the RE-LY trial. Ann Intern Med 2011; 155: 660-7, W204.
28. Nagarakanti R, Ezekowitz MD, Oldgren J, et al. Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion. Circulation 2011; 123: 131-6.
29. Wallentin L, Yusuf S, Ezekowitz MD, et al.; RE-LY Investigators. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 2010; 376: 975-83.
30. Diener HC, Connolly SJ, Ezekowitz MD, et al.; RE-LY study group. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol 2010; 9: 1157-63.
31. European Medicines Agency. Pradaxa (dabigatran etexilate). Product information. http://www.ema.europa.eu/ema/index.jsp? curl=pages/medicines/human/medicines/000829/human_med_0009 81.jsp&mid=WC0b01ac058001d124. Accessed April 21, 2012.
32. Food and Drug Administration. Pradaxa (dabigatran etexilate mesylate). Labeling revision. http://www.accessdata.fda.gov/ drugsatfda_ docs/label/2012/022512s009lbl.pdf. Accessed April 21, 2012.
33. Lip GY, Rasmussen LH, Olsson SB, et al. Oral direct thrombin inhibitor AZD0837 for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: a Phase II study of AZD0837 in patients who are appropriate for but unable or unwilling to take vitamin K antagonist therapy. Thromb Res 2011; 127: 91-9.
34. Lip GY, Rasmussen LH, Olsson SB, et al. Oral direct thrombin inhibitor AZD0837 for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: a randomized dose-guiding, safety, and tolerability study of four doses of AZD0837 vs. vitamin K antagonists. Eur Heart J 2009; 30: 2897-907.
35. http://clinicaltrials.gov/ct2/show/NCT00645853
36. Padma S, Majaz M. Intra-arterial versus intra-venous thrombolysis within and after the first 3 hours of stroke onset. Arch Med Sci 2010; 6: 303-315.
37. Eriksson BI, Borris LC, Dahl OE, et al, ODIXa-HIP Study Investigators. A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement. Circulation 2006; 114: 2374-81.
38. Eriksson BI, Borris LC, Friedman RJ, et al, RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med, 2008; 358: 2765-75.
39. Eriksson BI, Friedman RJ. Dabigatran etexilate: pivotal trials for venous thromboembolism prophylaxis after hip or knee arthroplasty. Clin Appl Thromb Hemost 2009; 15 Suppl 1: 25S-31S.
40. Lassen MR, Ageno W, Borris LC, et al.; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008; 358: 2776-86.
41. EINSTEIN Investigators, Bauersachs R, Berkowitz SD, Brenner B, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499-510.
42. Weinz C, Schwarz T, Kubitza D, Mueck W, Lang D. Metabolism and excretion of rivaroxaban, an oral, direct factor Xa inhibitor, in rats, dogs, and humans. Drug Metab Dispos 2009; 37: 1056-64.
43. 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: 873-80.
44. 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: 412-21.
45. 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: 2757-65.
46. 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; 70: 703-12.
47. 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: 67-77.
48. Patel MR, Mahaffey KW, Garg J, et al; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883-91.
49. 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: 2387-94.
50. Hankey GJ, Patel MR, Stevens SR, et al, for the RAFSCI. 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: 315-22.
51. European Medicines Agency. Xarelto (rivaroxaban). Product information. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/hu man/medicines/000944/human_med_001155.jsp&mid=WC0b01ac 058001d124. Accessed April 21, 2012.
52. Food and Drug Administration. Xarelto (rivaroxaban). Labeling revision. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022406 s000lbl.pdf. Accessed April 21, 2012.
53. Connolly SJ, Eikelboom J, Joyner C, et al.; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med 2011; 364: 806-17.
54. 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.
55. 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.
56. Raskob GE, Gallus AS, Pineo GF, et al. Apixaban versus enoxaparin for thromboprophylaxis after hip or knee replacement: pooled analysis of major venous thromboembolism and bleeding in 8464 patients from the ADVANCE-2 and ADVANCE-3 trials. J Bone Joint Surg Br 2012; 94: 257-64.
57. Lawrence J, Pogue J, Synhorst D, et al, investigators ASCA. Apixaban versus aspirin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a predefined subgroup analysis from AVERROES, a randomised trial. Lancet Neurol 2012; 11: 225-31.
58. Granger CB, Alexander JH, McMurray JJ, et al.; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: 981-92.
59. European Medicines Agency. Eliquis (apixaban). Product information. http://www.ema.europa.eu/ema/index.jsp?curl=pages/ medicines/ human/medicines/002148/human_med_001449.jsp&mid=W C0b01ac058001d124. Accessed April 21, 2012.
60. Weitz JI, Connolly SJ, Patel I, et al. Randomised, parallel-group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation. Thromb Haemost 2010; 104: 633-41.
61. Ogata K, Mendell-Harary J, Tachibana M, et al. Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers. J Clin Pharmacol 2010; 50: 743-53.
62. Ruff CT, Giugliano RP, Antman EM, et al. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AFTIMI 48). Am Heart J 2010; 160: 635-41.
63. Wońakowska-Kapłon B, Bartkowiak R, Grabowska U, Janiszewska G. Persistent atrial fibrillation is not associated with thrombomodulin level increase in efficiently anticoagulated patients. Arch Med Sci 2010; 6: 887-91.
64. 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: 1573-9.
65. Pandazi A, Karamanis P, Matsota P, Kontogiannopoulou S, Soultanis K, Kostopanagiotou G. Epidural haematoma after epidural catheter removal under multiple anticoagulant therapy: report of two cases. Arch Med Sci 2010; 6: 281-2.
66. Kowalczyk M, Banach M, Mikhailidis DP, Hannam S, Rysz J. Ticagrelor--a new platelet aggregation inhibitor in patients with acute coronary syndromes. An improvement of other inhibitors? Med Sci Monit 2009; 15: MS24-30.
67. 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
68. Soff GA. A new generation of oral direct anticoagulants. Arterioscler Thromb Vasc Biol 2012; 32: 569-74.
69. Bielecka-Dabrowa A, Mikhailidis DP, Rysz J, Banach M. The mechanisms of atrial fibrillation in hyperthyroidism. Thyroid Res 2009; 2: 4.
70. Schulman S, Crowther MA. How I treat with anticoagulants in 2012: new and old anticoagulants, and when and how to switch. Blood 2012; 119: 3016-23.