Direct anticoagulant drugs to overcome limitations of vitamin K antagonists. A critical appraisal of data in atrial fibrillation patients

Expert Opinion on Emerging Drugs

Volumn 18, Issue 1, 2013, Pages 9-23

  Di Minno, Matteo Nicola Dario ^a   Russolillo, Anna ^a   Di Minno, Alessandro ^a   Camera, Marina ^b,c   Parolari, Alessandro ^b   Tremoli, Elena ^b,c  

^a UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^b UNIVERSITY OF MILAN   (Italy)

^c CENTRO CARDIOLOGICO MONZINO   (Italy)

Author keywords

Atrial fibrillation; New anticoagulant drugs; Stroke prevention

Indexed keywords

ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; ANTIVITAMIN K; APIXABAN; CLOPIDOGREL; DABIGATRAN; DABIGATRAN ETEXILATE; DRONEDARONE; RIVAROXABAN; VERAPAMIL; WARFARIN;

ANTICOAGULANT THERAPY; AREA UNDER THE CURVE; BLEEDING; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CEREBROVASCULAR ACCIDENT; CLINICAL PRACTICE; CLINICAL TRIAL; DRUG COST; DRUG EFFICACY; DRUG HALF LIFE; DRUG METABOLISM; HEART ATRIUM FIBRILLATION; HUMAN; INTERNATIONAL NORMALIZED RATIO; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MORTALITY; REVIEW; TREATMENT OUTCOME;

ANIMALS; ANTICOAGULANTS; ANTIMETABOLITES; ANTITHROMBINS; ATRIAL FIBRILLATION; CLINICAL TRIALS AS TOPIC; DRUGS, INVESTIGATIONAL; HUMANS; INTRACRANIAL HEMORRHAGES; STROKE; VITAMIN K;

EID: 84874637323     PISSN: 14728214     EISSN: None     Source Type: Journal    
DOI: 10.1517/14728214.2013.777427     Document Type: Review

References (70)

1. 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;31:2369-29
2. Hankey GJ. Long-term outcome after ischaemic stroke/transient ischaemic attack. Cerebrovasc Dis 2003;16(Suppl 1):14-19 (Pubitemid 36438779)
3. Hart G, Pearce LA, Aguilar MI. Metaanalysis: antithrombotic therapy to prevent stroke in patients who have non-valvular atrial fibrillation. Ann Intern Med 2007;146:857-67 (Pubitemid 351650486)
4. Lovelock CE, Cordonnier C, Naka H, et al. Antithrombotic drug use, cerebral microbleeds, and intracerebral hemorrhage: a systematic review of published and unpublished studies. Stroke 2010;41:1222-8
5. Di Minno MND, Russolillo A, Camera M, et al. New anti-thrombotic drugs for stroke prevention. Curr Vasc Pharmacol 2011;22:723-32
6. Russolillo A, Di Minno MND, Tufano A, et al. Filling the gap between science and clinical practice: prevention of stroke recurrence. Thromb Res 2012;129:3-8
7. Hylek EM, Go AS, Chang Y, et al. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med 2003;349:1019-26 (Pubitemid 37087616)
8. Berger JS, Brown DL, Becker RC. Low-dose aspirin in patients with stable cardiovascular disease: a meta-analysis. Am J Med 2008;121:43-9
9. Antithrombotic Trialists' Collaboration. Collaborative metaanalysis of randomized trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002;324:71-86
10. Connolly S, Pogue J, Hart R, et al. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet 2006;367:1903-12
11. Connolly SJ, Pogue J, Hart RG, et al. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med 2009;360:2066-78
12. Connolly SJ, Eikelboom JW, Ng J, et al. ACTIVE (Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events) Steering Committee and Investigators. Net clinical benefit of adding clopidogrel to aspirin therapy in patients with atrial fibrillation for whom vitamin K antagonists are unsuitable. Ann Intern Med 2011;155:579-86
13. Mercaldi CJ, Ciarametaro M, Hahn B, et al. Cost efficiency of anticoagulation with warfarin to prevent stroke in medicare beneficiaries with nonvalvular atrial fibrillation. Stroke 2011;42:112-18
14. Dhamoon MS, Sciacca RR, Rundek T, et al. Recurrent stroke and cardiac risk after first ischemic stroke: the Northen Manhattan Study. Neurology 2006;66:641-6 (Pubitemid 43739815)
15. Warlow C, Suldow C, Dennis M, et al. Stroke. Lancet 2003;362:1211-24 (Pubitemid 37255350)
16. Marsh JD, Keyrouz SG. Stroke prevention and treatment. J Am Coll Cardiol 2010;56:683-91
17. Alaszewski A, Alaszewski H, Potter J, et al. Working after a stroke: survivors' experiences and perceptions of barriers to and facilitators of the return to paid employment. Disabil Rehabil 2007;29:1858-69 (Pubitemid 350168021)
18. Teasell RW, McRae MP, Finestone HM. Social issues in the rehabilitation of younger stroke patients. Arch Phys Med Rehabil 2000;81:205-9 (Pubitemid 30080680)
19. Wozniak MA, Kittner SJ. Return to work after ischemic stroke: a methodological review. Neuroepidemiology 2002;21:159-66 (Pubitemid 34639044)
20. Essue BM, Hackett ML, Li Q, et al. How are household economic circumstances affected after a stroke?: the Psychosocial Outcomes In StrokE (POISE) Study. Stroke 2012;43:3110-13
21. Peterson ED, Roe MT, Mulgund J, et al. Association between hospital process performance and outcomes among patients with acute coronary syndromes. JAMA 2006;295:1912-20
22. Ansell J. Factor Xa or thrombin: is factor Xa a better target? J Thromb Haemost 2007;5(Suppl 1):60-4 (Pubitemid 46958817)
23. Moser M, Bode C. Anticoagulation in atrial fibrillation-a new era has begun. Hamostaseologie 2012;32:37-9
24. Marijon E, Fauchier L, Le Heuzey JY. New antithrombotic drugs and European approval processes. Lancet 2011;378:662-3
25. Weitz JI, Bates SM. New anticoagulants. J Thromb Haemost 2005;3:1843-53 (Pubitemid 41716571)
26. Samama MM. The mechanism of action of rivaroxaban-an oral, direct factor Xa inhibitor-compared with other anticoagulants. Thromb Res 2011;127:497-504
27. Weitz JI. Factor Xa or thrombin: is thrombin a better target? J Thromb Haemost 2007;5(Suppl 1):65-7 (Pubitemid 46958818)
28. Sorbera LA, Bozzo J, Castaner J. Dabigatran/Dabigatran etexilate. Drugs Fut 2005;30:877-85
29. Brunet A, Hermabassiere S, Benain X. Pharmaco Kinetic and pharmacodynamic interaction of dronedarone and dabigatran in healthy subjects [abstracts]. ESC 2011 Congress
30. 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;3:514-21 (Pubitemid 41632877)
31. Jiang X, Crain EJ, Luettgen JM, et al. Apixaban, an oral direct factor Xa inhibitor, inhibitis human clot-bound factor Xa activity in vitro. Thromb Haemost 2009;101:780-2
32. 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
33. Patel MR, Mahaffey KW, Garg J, et al. ROCKET AF Investigators. Rivaroxaban versus warfarin in non-valvular atrial fibrillation. N Engl J Med 2011;365:883-91
34. 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
35. Ntaios G, Papavasileiou V, Diener HC, et al. Nonvitamin-K-antagonist oral anticoagulants in patients with atrial fibrillation and previous stroke or transient ischemic attack: a systematic review and meta-analysis of randomized controlled trials. Stroke 2012;43:3298-304
36. Kwong JSW, Lam YY, Yan BP, et al. Bleeding of new oral anticoagulants for stroke prevention in atrial fibrillation: a meta-analysis of randomized controlled trials. Cardiovasc Drugs Ther 2013;27:23-35
37. Mantha S, Ansell J. An indirect comparison of dabigatran, rivaroxaban and apixaban for atrial fibrillation. Thromb Haemost 2012;108:476-84
38. Lee S, Monz BU, Clemens A, et al. Representativeness of the dabigatran, apixaban and rivaroxaban clinical trial populations to real-world atrial fibrillation patients in the United Kingdom: a cross-sectional analysis using the General Practice Research Database. BMJ Open 2012;2(6):pii: e001768
39. Furugohri T, Isobe K, Honda Y, et al. DU-176b, a potent and orally active factor Xa inhibitor: in vitro and in vivo pharmacological profiles. J Thromb Haemost 2008;6:1542-9
40. Ruff CT, Giugliano RP, Antman EM, et al. Evaluation of the novel factor Xa inhibitor edoxaban compared with VKA 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 AF-TIMI 48). Am Heart J 2010;160:635-41
41. Pehrsson S, Johansson K, Kjaer M, et al. Evaluation of AR-H067637, the active metabolite of the new direct thrombin inhibitor AZD0837, in models of venous and arterial thrombosis and bleeding in anaesthetised rats. Thromb Haemost 2010;104:1242-9
42. Deinum J, Mattsson C, Inghardt T, et al. Biochemical and pharmacological effects of the direct thrombin inhibitor AR-H067637. Thromb Haemost 2009;101:1051-9
43. Olsson SB, Rasmussen LH, Tveit A, et al. Safety and tolerability of an immediate-release formulation of the oral direct thrombin inhibitor AZD0837 in the prevention of stroke and systemic embolism in patients with atrial fibrillation. Thromb Haemost 2010;103:604-12
44. Pletscher M, Plessow R, Eichler K, et al. Cost-effectiveness of Dabigatran for stroke prevention in atrial fibrillation in Switzerland. Swiss Med Wkly 2013;143-0 doi: 10.4414/smw.2013.13732
45. Lee S, Mullin R, Blazawski J, Coleman CI. Cost-effectiveness of apixaban compared with warfarin for stroke prevention in atrial fibrillation. PLoS One 2012;7:e47473
46. Deitelzweig S, Amin A, Jing Y, et al. Medical cost reductions associated with the usage of novel oral anticoagulants vs warfarin among atrial fibrillation patients, based on the RE-LY, ROCKET-AF, and ARISTOTLE trials. J Med Econ 2012;15:1-10
47. Miller CS, Grandi SM, Shimony A, et al. Meta-analysis of efficacy and safety of new oral anticoagulants (Dabigatran, Rivaroxaban, Apixaban) versus VKA in patients with atrial fibrillation. Am J Cardiol 2012;110:453-60
48. Furie KL, Goldstein LB, Albers GW, et al. American Heart Association Stroke Council; Council on Quality of Care and Outcomes Research; Council on Cardiovascular Nursing; Council on Clinical Cardiology; Council on Peripheral Vascular Disease. Oral antithrombotic agents for the prevention of stroke in nonvalvular atrial fibrillation: a science advisory for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2012;43:3442-53
49. Michel J, Mundell D, Boga T, et al. Dabigatran for anticoagulation in atrial fibrillation-early clinical experience in a hospital population and comparison to trial data. Heart Lung Circ 2013;22:50-5
50. European Medicines Agency updates patient and prescriber information for Pradaxa. Available from: http://www. ema.europa.eu/docs/en-GB/document-library/ Press-release/2012/05/WC500127771.pdf
51. Cohen AT, Spiro TE, Bu HR, et al. Extended-duration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol. J Thromb Thrombolysis 2011;31:407-16
52. Goldhaber SZ, Leizorovicz A, Kakkar AK, et al. ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med 2011;365:2167-77
53. Dans AL, Connolly SJ, Wallentin L, et al. Concomitant use of antiplatelet therapy with dabigatran or warfarin in the randomized evaluation of long-term anticoagulation therapy (RE-LY) Trial. Circulation 2013;127:634-40
54. Alexander JH, Lopes RD, James S, et al. APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med 2011;365:699-708
55. Mega JL, Braunwald E, Wiviott SD, et al. ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med 2012;366:9-19
56. Hamm CW, Bassand JP, Agewall S, et al. ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: the Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J 2011;32:2999-3054
57. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol 2011;58:e44-122
58. Di Minno MND, Guida A, Camera M, et al. Overcoming limitations of current anti-platelet drugs. A concerted effort for more profitable strategies of intervention. Ann Med 2011;43:531-44
59. Di Minno MND, Momi S, Di Minno A, Russolillo A. Stroke prevention: from available antiplatelet drugs to novel molecular targets. Curr Drug Targets 2012. [Epub ahead of print]
60. Healey JS, Eikelboom J, Douketis J, et al. Peri-Procedural bleeding and thromboembolic events with dabigatran compared to warfarin: results from the RE-LY randomized trial circulation. 2012;126:343-8
61. Banerjee A, Lane DA, Torp-Pedersen C, et al. Net clinical benefit of new oral anticoagulants (Dabigatran, Rivaroxaban, Apixaban) versus no treatment in a 'real world' atrial fibrillation population: a modelling analysis based on a nationwide cohort study. Thromb Haemost 2012;107:584-9
62. 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
63. Eikelboom JW, Wallentin L, Connolly SJ, et al. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation 2011;123:2363-72
64. Van de Werf F, Brueckmann M, Connolly SJ, et al. A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: the randomized, phase II study to evaluate the safety and pharmacokinetics of oral dabigatran etexilate in patients after heart valve replacement (RE-ALIGN). Am Heart J 2012;163:931-7
65. Food and drug administration Briefing Information for the September 20, 2010 Meeting of the Cardiovascular and Renal Drugs Advisory Committee. Available from: http://www.fda.gov/AdvisoryCommittees/Committees MeetingMaterials/Drugs/ CardiovascularandRenalDrugs AdvisoryCommittee/ucm226008.htm
66. Marlu R, Hodaj E, Paris A, et al. Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban: a randomised crossover ex vivo study in healthy volunteers. Thromb Haemost 2012;108:217-24
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;124:1573-9
68. 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):S141-5
69. Siegal DM, Crowther MA. Acute management of bleeding in patients on novel oral anticoagulants. Eur Heart J 2012; [Epub ahead of print]
70. Di Pasquale G, Riva L. Thromboembolic prophylaxis 2011: is warfarin on the wane? G Ital Cardiol 2011;12:556-65