New options with dabigatran etexilate in anticoagulant therap

Vascular Health and Risk Management

Volumn 6, Issue 1, 2010, Pages 339-349

  Maegdefessel, Lars ^a   Spin, Joshua M ^a   Azuma, Junya ^a   Tsao, Philip S ^a  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Anticoagulation; Dabigatran etexilate; Direct thrombin inhibitors; Prevention; Thrombosis

Indexed keywords

ACENOCOUMAROL; AMIODARONE; ANTIVITAMIN K; APIXABAN; ARGATROBAN; BEMIPARIN; CERTOPARIN; DABIGATRAN ETEXILATE; DALTEPARIN; DANAPAROID; ENOXAPARIN; FONDAPARINUX; HEPARIN; HIRULOG; LEPIRUDIN; LOW MOLECULAR WEIGHT HEPARIN; NADROPARIN; PARNAPARIN; PHENPROCOUMON; PRADAX; QUINIDINE; RECOMBINANT BLOOD CLOTTING FACTOR 7A; REVIPARIN; RIVAROXABAN; TINZAPARIN; UNCLASSIFIED DRUG; VERAPAMIL; WARFARIN; XIMELAGATRAN; ANTICOAGULANT AGENT; BENZIMIDAZOLE DERIVATIVE; FIBRINOLYTIC AGENT; PYRIDINE DERIVATIVE; THROMBIN;

ACUTE CORONARY SYNDROME; ANTICOAGULANT THERAPY; AREA UNDER THE CURVE; ATHEROSCLEROSIS; BLEEDING; COMPETITIVE INHIBITION; DEEP VEIN THROMBOSIS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG COMPETITION; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDICATION; DRUG POTENCY; DRUG POTENTIATION; DRUG SAFETY; DRUG TARGETING; DRUG WITHDRAWAL; DYSPEPSIA; HEART ATRIUM FIBRILLATION; HEART VALVE REPLACEMENT; HUMAN; LIVER TOXICITY; MAXIMUM PLASMA CONCENTRATION; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; PARTIAL THROMBOPLASTIN TIME; POSTTHROMBOSIS SYNDROME; PROSTHETIC VALVE THROMBOSIS; PROTHROMBIN TIME; PULMONARY HYPERTENSION; RECURRENT DISEASE; REVIEW; RISK REDUCTION; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; STROKE; THROMBOEMBOLISM; UNSTABLE ANGINA PECTORIS; VENOUS THROMBOEMBOLISM; ANIMAL; BLOOD; BLOOD CLOTTING; CARDIOVASCULAR DISEASE; CHEMICALLY INDUCED DISORDER; DRUG ADMINISTRATION; DRUG ANTAGONISM; DRUG EFFECT; DRUG INTERACTION; ORAL DRUG ADMINISTRATION; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ANIMALS; ANTICOAGULANTS; BENZIMIDAZOLES; BLOOD COAGULATION; CARDIOVASCULAR DISEASES; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; FIBRINOLYTIC AGENTS; HEMORRHAGE; HUMANS; PYRIDINES; THROMBIN; TREATMENT OUTCOME;

EID: 77955915595     PISSN: 11766344     EISSN: 11782048     Source Type: Journal    
DOI: 10.2147/vhrm.s8942     Document Type: Review

References (60)

1. Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of Venous Thromboembolism: American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;381S-453S.
2. Moll S, Mackman N. Venous thromboembolism: a need for more public awareness and research into mechanisms. Arterioscler Thromb Vasc Biol. 2008;28:367-369.
3. Cohen AT, Tapson VF, Bergmann JF, et al; ENDORSE Investigators. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008;371:387-394.
4. Lapostolle F, Surget V, Borron SW, et al. Severe pulmonary embolism associated with air travel. N Engl J Med. 2001;345:779-783.
5. Francis CW. Clinical practice. Prophylaxis for thromboembolism in hospitalized medical patients. N Engl J Med. 2007;356:1438-1444.
6. Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000;160:809-815.
7. White RH. The epidemiology of venous thromboembolism. Circulation. 2003;107:I4-I8.
8. Kearon C. Natural history of venous thromboembolism. Circulation. 2003;107:I22-I30.
9. Rodger MA, Kahn SR, Wells PS, et al. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ. 2008;179:417-426.
10. Kahn SR. The post-thrombotic syndrome: the forgotten morbidity of deep venous thrombosis. J Thromb Thrombolysis. 2006;21:41-48.
11. Haenen JH, Janssen MC, van Langen H, et al. The postthrombotic syndrome in relation to venous hemodynamics, as measured by means of duplex scanning and strain-gauge plethysmography. J Vasc Surg. 1999;29:1071-1076.
12. Prandoni P, Lensing AW, Cogo A, et al. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996;125:1-7.
13. Pengo V, Lensing AW, Prins MH, et al. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med. 2004;350:2257-2264.
14. Fedullo PF, Auger WR, Kerr KM, Rubin LJ. Chronic thromboembolic pulmonary hypertension. N Engl J Med. 2001;345:1465-1472.
15. Singer DE, Albers GW, Dalen JE, et al; American College of Chest Physicians. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133:546-592.
16. Lip G, Nieuwlaat R, Pisters R, Lane D, Crijns H. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor based approach: The Euro Heart Survey on Atrial Fibrillation. Chest. 2010;137:263-272.
17. Schnabel RB, Sullivan LM, Levy D, et al. Development of a risk score for atrial fibrillation (Framingham Heart Study): a community-based cohort study. Lancet. 2009;373:739-745.
18. Hylek EM. Antithrombotic prophylaxis in elderly patients with atrial fibrillation. Semin Thromb Hemost. 2009;35:548-553.
19. Levi M, Hobbs FD, Jacobson AK, et al. Improving antithrombotic management in patients with atrial fibrillation: current status and perspectives. Semin Thromb Hemost. 2009;35:527-542.
20. Pisters R, de Vos CB, Nieuwlaat R, Crijns HJ. Use and underuse of oral anticoagulation for stroke prevention in atrial fibrillation: old and new paradigms. Semin Thromb Hemost. 2009;35:554-559.
21. Levi M, de Peuter OR, Kamphuisen PW. Management strategies for optimal control of anticoagulation in patients with atrial fibrillation. Semin Thromb Hemost. 2009;35:560-567.
22. Anderson JL, Adams CD, Antman EM, et al; American College of Cardiology; American Heart Association Task Force on Practice Guidelines. 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. J Am Coll Cardiol. 2007;50:1-157.
23. Vickrey BG, Rector TS, Wickstrom SL, et al. Occurrence of secondary ischemic events among persons with atherosclerotic vascular disease. Stroke. 2002;33:901-906.
24. Cannegieter SC, Torn M, Rosendaal FR. Oral anticoagulant treatment in patients with mechanical heart valves: how to reduce the risk of thromboembolic and bleeding complications. J Intern Med. 1999;245:369-374.
25. American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons,
26. Bonow RO, Carabello BA, Kanu C, et al. ACC/AHA guidelines for the management of patients with valvular heart disease. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease. Circulation. 2006;114:84-231.
27. Vahanian A, Baumgartner H, Bax J, et al; Task Force on the Management of Valvular Hearth Disease of the European Society of Cardiology; ESC Committee for Practice Guidelines. Guidelines on the management of valvular heart disease. Eur Heart J. 2007;28: 230-268.
28. Hirsh J, Guyatt G, Albers GW, Harrington R, Schünemann HJ; American College of Chest Physician. Antithrombotic and thrombolytic therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133:110-112.
29. Eikelboom JW, Weitz JI. A replacement for warfarin: the search continues. Circulation. 2007;116:131-133.
30. Hirsh J, O'Donnell M, Eikelboom JW. Beyond unfractionated heparin and warfarin: current and future advances. Circulation. 2007;116: 552-560.
31. Frydman A. Low-molecular-weight heparins: an overview of their pharmacodynamics, pharmacokinetics and metabolism in humans. Haemostasis. 1996;26:24-38.
32. Bick RL, Frenkel EP, Walenga J, Fareed J, Hoppensteadt DA. Unfractionated heparin, low molecular weight heparins, and pentasaccharide: basic mechanism of actions, pharmacology, and clinical use. Hematol Oncol Clin North Am. 2005;19:1-51.
33. Vesely MR, Kelemen MD. Cardiac risk assessment: matching intensity of therapy to risk. Cardiol Clin. 2006;24:67-78.
34. Warkentin TE, Greinacher A, Koster A, and Lincoff AM. Treatment and Prevention of Heparin-Induced Thrombocytopenia: American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;340S-380S.
35. Chaturvedi V, Karthikeyan G. Fondaparinux in acute coronary syndromes. Expert Opin Drug Metab Toxicol. 2009;5:1615-1623.
36. Harenberg J, Wehling M. Current and future prospects for anticoagulant therapy: inhibitors of factor Xa and factor IIa. Semin Thromb Hemost. 2008;34:39-57.
37. Haas S. New anticoagulants- towards the development of an "ideal" anticoagulant. Vasa. 2009;38:13-29.
38. Wienen W, Stassen JM, Priepke H, Ries UJ, Hauel N. Antithrombotic and anticoagulant effects of the direct thrombin inhibitor dabigatran, and its oral prodrug, dabigatran etexilate, in a rabbit model of venous thrombosis. J Thromb Haemost. 2007;5:1237-1242.
39. Stangier J, Rathgen K, Stähle 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.
40. Eriksson BI, Smith H, Yasothan U, Kirkpatrick P. Dabigatran etexilate. Nat Rev Drug Discov. 2008;7:557-558.
41. Haas S. New oral Xa and IIa inhibitors: updates on clinical trial results. J Thromb Thrombolysis. 2008;25:52-60.
42. Wolowacz SE, Roskell NS, Plumb JM, et al. Economic evaluation of dabigatran etexilate for the preventionof venous thromboembolism in patients aged over 75 years or with moderate renal impairment undergoing total knee or hip replacement. Thromb Haemost. 2010;103:360-371.
43. Stangier J, Clemens A. Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor. Clin Appl Thromb Hemost. 2009 Aug 19. [Epub ahead of print]. Dahl OE. Dabigatran etexilate: A new oral thrombin inhibitor. therapy. 2008;5:1-11.
44. Wienen W, Stassen JM, Priepke H, Ries UJ, Hauel N. In-vitro profile and ex-vivo anticoagulant activity of the direct thrombin inhibitor dabigatran and its orally active prodrug, dabigatran etexilate. Thromb Haemost. 2007;98:155-162.
45. Eriksson BI, Dahl OE, Rosencher N, et al; RE-MODEL Study Group. Oral dabigatran etexilate vs subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the REMODEL randomized trial. J thromb Haemost. 2007;5:2178-2185.
46. Eriksson BI, Dahl OE, Rosencher N, et al; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949-956.
47. Ginsberg JS, Davidson BL, Comp PC, et al. RE-MOBILIZE Writing Committee. 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.
48. Fuji T, Fuijita S, Ujihira T, Sato T. Dabigatran etexilate prevents venous thromboembolism after total knee arthroplasty in Japanese patients, with a safety profile comparable to placebo. J Arthroplasty. 2009 Oct 24. [Epub ahead of print].
49. Schulman S, Kearon C, Kakkar AK, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361:2342-2352.
50. Qureshi AI, Feldmann E, Gomez CR, et al. Intracranial atherosclerotic disease: an update. Ann Neurol. 2009;66:730-738.
51. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007;146:857-867.
52. Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001;285:2864-2870.
53. 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;361:1139-1151.
54. Gage BF. Can we rely on RE-LY? N Engl J Med. 2009;361: 1200-1202.
55. Herijgers P, Verhamme P. Improving the quality of anticoagulant therapy in patients with mechanical heart valves: what are we waiting for? Eur Heart J. 2007;28:2424-2426.
56. Viles-Gonzalez JF, Fuster V, Badimon JJ. Atherothrombosis: a widespread disease with unpredictable and life-threatening consequences. Eur Heart J. 2004;25:1197-1207.
57. Turpie AG. Direct Factor Xa and direct thrombin inhibitors: a clinical trial update. Curr Opin Drug Discov Devel. 2009;12:497-508.
58. Holmes DR Jr, Kereiakes DJ, Kleiman NS, et al. Combining antiplatelet and anticoagulant therapies. J Am Coll Cardiol. 2009;54:95-109.
59. Weitz JI. Factor Xa or thrombin: is thrombin a better target? J Thromb Haemost. 2007;5:65-67.
60. Mackman N. Triggers, targets and treatments for thrombosis. Nature. 2008;451:914-918.