New anticoagulants for atrial fibrillation

Journal of Cardiovascular Medicine

Volumn 10, Issue 6, 2009, Pages 446-453

  De Caterina, Raffaele ^a,c   Kristensen, Steen Dalby ^b   Renda, Giulia ^a  

^a UNIVERSITY OF CHIETI   (Italy)

^b AARHUS UNIVERSITY HOSPITAL   (Denmark)

^c University Cardiology Division   (Italy)

Author keywords

Atrial fibrillation; Gatrans; Vitamin K antagonists; Warfarin; Xabans

Indexed keywords

ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; ANTITHROMBIN III; ANTIVITAMIN K; APIXABAN; AZD 0837; BLOOD CLOTTING FACTOR 10A INHIBITOR; BMS 562248 01; CLOPIDOGREL; COUMARIN DERIVATIVE; DABIGATRAN ETEXILATE; DU 176 B; DU 176B; ENOXAPARIN; FONDAPARINUX; HEPARIN; HIRUDIN DERIVATIVE; IDRAPARINUX; IRBESARTAN; LOW MOLECULAR WEIGHT HEPARIN; LY 5157117; METOPROLOL; PENTASACCHARIDE; PEPTIDOMIMETIC AGENT; RAZAXABAN; RIVAROXABAN; THROMBIN INHIBITOR; TICLOPIDINE; UNCLASSIFIED DRUG; UNINDEXED DRUG; WARFARIN; XIMELAGATRAN; YM 150; ANTITHROMBOCYTIC AGENT; BLOOD CLOTTING FACTOR 10A; FIBRINOLYTIC AGENT; NEW DRUG; THROMBIN; VITAMIN K GROUP;

ACUTE CORONARY SYNDROME; ALCOHOL CONSUMPTION; BINDING AFFINITY; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DEEP VEIN THROMBOSIS; DRUG ABSORPTION; DRUG BINDING; DRUG BIOAVAILABILITY; DRUG CLASSIFICATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDUSTRY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; EMBOLISM; GASTROINTESTINAL TRACT; GENETIC POLYMORPHISM; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HEREDITY; HUMAN; INTERNATIONAL NORMALIZED RATIO; LIVER DYSFUNCTION; LIVER INJURY; LUNG EMBOLISM; MONOTHERAPY; MORBIDITY; MORTALITY; PATIENT COMPLIANCE; PERCUTANEOUS CORONARY INTERVENTION; REVIEW; SIDE EFFECT; STROKE; THROMBOEMBOLISM; THROMBOSIS; THROMBOSIS PREVENTION; UNSTABLE ANGINA PECTORIS; VEIN THROMBOSIS; VENOUS THROMBOEMBOLISM; BLEEDING; CHEMICALLY INDUCED DISORDER; DRUG ANTAGONISM; INJECTION; ORAL DRUG ADMINISTRATION; RISK ASSESSMENT; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ANTICOAGULANTS; ATRIAL FIBRILLATION; COUMARINS; DRUGS, INVESTIGATIONAL; FACTOR XA; FIBRINOLYTIC AGENTS; HEMORRHAGE; HUMANS; INJECTIONS; PLATELET AGGREGATION INHIBITORS; RISK ASSESSMENT; STROKE; THROMBIN; THROMBOSIS; TREATMENT OUTCOME; VITAMIN K;

EID: 67649201775     PISSN: 15582027     EISSN: None     Source Type: Journal    
DOI: 10.2459/JCM.0b013e3283249aee     Document Type: Review

References (60)

1. Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation). Eur Heart J 2006; 27:1979-2030. (Pubitemid 44313588)
2. Albers GW, Dalen JE, Laupacis A, Manning WJ, Petersen P, Singer DE. Antithrombotic therapy in atrial fibrillation. Chest 2001; 119:194S-206S.
3. Cairns JA, Connolly SJ. Nonrheumatic atrial fibrillation. Risk of stroke and role of antithrombotic therapy. Circulation 1991; 84:469-481.
4. Palareti G, Leali N, Coccheri S, Poggi M, Manotti C, D'Angelo A, et al. Bleeding complications of oral anticoagulant treatment: an inceptioncohort, prospective collaborative study (ISCOAT). Italian study on complications of oral anticoagulant therapy. Lancet 1996; 348:423-428. (Pubitemid 26267872)
5. Bleeding during antithrombotic therapy in patients with atrial fibrillation. The stroke prevention in atrial fibrillation investigators. Arch Intern Med 1996; 156:409-416. (Pubitemid 26067316)
6. Levine MN, Raskob G, Landefeld S, Kearon C. Hemorrhagic complications of anticoagulant treatment. Chest 1998; 114:511S-523S.
7. Hart RG, Benavente O, Pearce LA. Increased risk of intracranial hemorrhage when aspirin is combined with warfarin: a meta-analysis and hypothesis. Cerebrovasc Dis 1999; 9:215-217.
8. Petersen P, Boysen G,Godtfredsen J, Andersen ED, Andersen B. Placebocontrolled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet 1989; 1:175-179. (Pubitemid 19038801)
9. 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; 323:1505-1511.
10. Stroke prevention in atrial fibrillation study. Final results. Circulation 1991; 84:527-539.
11. Ezekowitz MD, Bridgers SL, James KE, Carliner NH, Colling CL, Gornick CC, 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; 327:1406-1412.
12. 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. (Pubitemid 47343588)
13. Thrall G, Lane D, Carroll D, Lip GY. Quality of life in patients with atrial fibrillation: a systematic review. Am J Med 2006; 119:448.e1- 448.e19.
14. Rost S, Fregin A, Ivaskevicius V, Conzelmann E, Hortnagel K, Pelz HJ, et al. Mutations in VKORC1 cause warfarin resistance and multiple coagulation factor deficiency type 2. Nature 2004; 427:537-541. (Pubitemid 38209110)
15. Kamali F, Khan TI, King BP, Frearson R, Kesteven P, Wood P, et al. Contribution of age, body size, and CYP2C9 genotype to anticoagulant response to warfarin. Clin Pharmacol Ther 2004; 75:204-212. (Pubitemid 38314870)
16. Frykman V, Beerman B, Ryden L, Rosenqvist M. Management of atrial fibrillation: discrepancy between guideline recommendations and actual practice exposes patients to risk for complications. Eur Heart J 2001; 22:1954-1959. (Pubitemid 33054676)
17. Schror K. The basic pharmacology of ticlopidine and clopidogrel. Platelets 1993; 4:252.
18. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet 1996; 348:1329-1339.
19. Muller C, Buttner HJ, Petersen J, Roskamm H. A randomized comparison of clopidogrel and aspirin versus ticlopidine and aspirin after the placement of coronary-artery stents. Circulation 2000; 101:590-593. (Pubitemid 30094727)
20. Bertrand ME, Rupprecht HJ, Urban P, Gershlick AH, Investigators FT. Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting: the clopidogrel aspirin stent international cooperative study (CLASSICS). Circulation 2000; 102:624-629. (Pubitemid 30640661)
21. Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, et al. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001; 358:527-533. (Pubitemid 32772726)
22. Steinhubl SR, Berger PB, Mann JT 3rd, Fry ET, DeLago A, Wilmer C, Topol EJ. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JANA 2002; 288:2411-2420.
23. Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendon JL, Montalescot G, Theroux P, et al. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med 2005; 352:1179-1189. (Pubitemid 40397259)
24. Chen ZM, Jiang LX, Chen YP, Xie JX, Pan HC, Peto R, et al. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet 2005; 366:1607-1621. (Pubitemid 41552416)
25. Connolly S, Pogue J, Hart R, Pfeffer M, Hohnloser S, Chrolavicius S, 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; 367:1903-1912.
26. Suttie JW. The biochemical basis of warfarin therapy. Adv Exp Med Biol 1987; 214:3-16.
27. Rezaie AR. Prothrombin protects factor Xa in the prothrombinase complex from inhibition by the heparin-antithrombin complex. Blood 2001; 97:2308-2313.
28. Samama MM, Gerotziafas GT. Evaluation of the pharmacological properties and clinical results of the synthetic pentasaccharide (fondaparinux). Thromb Res 2003; 109:1-11.
29. Turpie AG, Bauer KA, Eriksson BI, Lassen MR. Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: a meta-analysis of 4 randomized double-blind studies. Arch Intern Med 2002; 162:1833-1840. (Pubitemid 35051694)
30. Buller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, et al. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Ann Intern Med 2004; 140:867-873. (Pubitemid 38685267)
31. Büller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, et al. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med 2003; 349:1695-1702. (Pubitemid 37315006)
32. Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, et al. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med 2006; 354:1464-1476.
33. Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, et al. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J 2007; 28:1598-1660.
34. Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol 2007; 50:e1-e157.
35. Herbert JM, Herault JP, Bernat A, van Amsterdam RG, Lormeau JC, Petitou M, et al. Biochemical and pharmacological properties of SANORG 34006, a potent and long-acting synthetic pentasaccharide. Blood 1998; 91:4197-4205. (Pubitemid 28261983)
36. Bousser MG, Bouthier J, Buller HR, Cohen AT, Crijns H, Davidson BL, et al. Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomised, openlabel, noninferiority trial. Lancet 2008; 371:315-321.
37. Prandoni P, Tormene D, Perlati M, Brandolin B, Spiezia L. Idraparinux: review of its clinical efficacy and safety for prevention and treatment of thromboembolic disorders. Expert Opin Investig Drugs 2008; 17:773-777. (Pubitemid 351843619)
38. Sarich TC, Eriksson UG, Mattsson C, Wolzt M, Frison L, Fager G, Gustafsson D. Inhibition of thrombin generation by the oral direct thrombin inhibitor ximelagatran in shed blood from healthy male subjects. Thromb Haemost 2002; 87:300-305. (Pubitemid 34139869)
39. Eriksson UG, Bredberg U, Hoffmann KJ, Thuresson A, Gabrielsson M, Ericsson H, et al. Absorption, distribution, metabolism, and excretion of ximelagatran, an oral direct thrombin inhibitor, in rats, dogs, and humans. Drug Metab Dispos 2003; 31:294-305. (Pubitemid 36249684)
40. Gustafsson D, Elg M. The pharmacodynamics and pharmacokinetics of the oral direct thrombin inhibitor ximelagatran and its active metabolite melagatran: a mini-review. Thromb Res 2003; 109 (Suppl 1):S9-S15. (Pubitemid 36724832)
41. Johansson LC, Andersson M, Fager G, Gustafsson D, Eriksson UG. No influence of ethnic origin on the pharmacokinetics and pharmacodynamics of melagatran following oral administration of ximelagatran, a novel oral direct thrombin inhibitor, to healthy male volunteers. Clin Pharmacokinet 2003; 42:475-484. (Pubitemid 36649040)
42. Sorbera LA, Bozzo J, Castaner J. Dabigatran/dabigatran etexilate. Drugs Future 2005; 30:877-885.
43. Eriksson BI, Dahl OE, Büller HR, Hettiarachchi R, Rosencher N, Bravo ML, et al. A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial. J Thromb Haemost 2005; 3:103-111. (Pubitemid 41647122)
44. Stangier J, Eriksson BI, Dahl OE, Ahnfelt L, Nehmiz G, Stahle H, et al. Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement. J Clin Pharmacol 2005; 45:555-563. (Pubitemid 40562946)
45. Eriksson BI, Dahl OE, Ahnfelt L, Kalebo P, Stangier J, Nehmiz G, et al. Dose escalating safety study of a new oral direct thrombin inhibitor, dabigatran etexilate, in patients undergoing total hip replacement: BISTRO I. J Thromb Haemost 2004; 2:1573-1580. (Pubitemid 40186173)
46. Ho SJ, Brighton TA. Ximelagatran: direct thrombin inhibitor. Vasc Health Risk Manag 2006; 2:49-58.
47. Wallentin L, Wilcox RG, Weaver WD, Emanuelsson H, Goodvin A, Nystrom P, Bylock A. Oral ximelagatran for secondary prophylaxis after myocardial infarction: the ESTEEM randomised controlled trial. Lancet 2003; 362:789-797. (Pubitemid 37093920)
48. Olsson SB. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with nonvalvular atrial fibrillation (SPORTIF III): randomised controlled trial. Lancet 2003; 362:1691-1698.
49. Albers GW, Diener HC, Frison L, Grind M, Nevinson M, Partridge S, et al. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. JAMA 2005; 293:690-698. (Pubitemid 40220342)
50. Lee WM, Larrey D, Olsson R, Lewis JH, Keisu M, Auclert L, Sheth S. Hepatic findings in long-term clinical trials of ximelagatran. Drug Saf 2005; 28:351-370. (Pubitemid 40545769)
51. Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, 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; 5:2178-2185. (Pubitemid 47617868)
52. Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, noninferiority trial. Lancet 2007; 370:949-995 (Pubitemid 47393577)
53. Lassen MR, Davidson BL, Gallus A. A phase II, randomized, double blind, five-arm, parallel-group, dose-response study of a new oral directly-acting factor Xa inhibitor, razaxaban, for prevention of deep vein thrombosis in knee-replacement surgery: on behalf of the Razaxaban Investigators [abstract no. 413]. Blood 2003; 102.
54. Eriksson BI, Borris L, Dahl OE, Haas S, Huisman MV, Kakkar AK, et al. Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement. J Thromb Haemost 2006; 4:121-128.
55. Turpie AG, Fisher WD, Bauer KA, Kwong LM, Irwin MW, Kalebo P, et al. BAY 59-7939: an oral, direct factor Xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement. A phase II dose-ranging study. J Thromb Haemost 2005; 3:2479-2486. (Pubitemid 41727165)
56. 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; 5:2368-2375. (Pubitemid 350154345)
57. Agnelli G, Haas S, Ginsberg JS, Krueger KA, Dmitrienko A, Brandt JT. A phase II study of the oral factor Xa inhibitor LY517717 for the prevention of venous thromboembolism after hip or knee replacement.
58. Eriksson BI, Turpie AG, Lassen MR, Prins MH, Agnelli G, Kalebo P, et al. A dose escalation study of YM150, an oral direct factor Xa inhibitor, in the prevention of venous thromboembolism in elective primary hip replacement surgery. J Thromb Haemost 2007; 5:1660-1665. (Pubitemid 47091408)
59. Zafar MU, Vorchheimer DA, Gaztanaga J, Velez M, Yadegar D, Moreno PR, et al. Antithrombotic effects of factor Xa inhibition with DU-176b: phase-I study of an oral, direct factor Xa inhibitor using an ex-vivo flow chamber. Thromb Haemost 2007; 98:883-888. (Pubitemid 47555083)
60. Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008; 358:2776-2786. (Pubitemid 351930852)