A new anticoagulant for a new era: Review of recent data on dabigatran etexilate

Clinical Advances in Hematology and Oncology

Volumn 8, Issue 10, 2010, Pages 697-702

  Faltas, Bishoy ^a  

^a UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

Author keywords

Dabigatran etexilate; New anticoagulants; Warfarin

Indexed keywords

DABIGATRAN ETEXILATE; ENOXAPARIN; LOW MOLECULAR WEIGHT HEPARIN; PLACEBO; THROMBIN; WARFARIN;

ACUTE CORONARY SYNDROME; ACUTE HEART INFARCTION; ANTICOAGULANT THERAPY; ARTICLE; BLEEDING; BRAIN HEMORRHAGE; CLINICAL TRIAL; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DEEP VEIN THROMBOSIS; DRUG APPROVAL; DRUG CHOICE; DRUG COST; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG TARGETING; DYSPEPSIA; EVENING DOSAGE; GASTROINTESTINAL HEMORRHAGE; HEART ATRIUM FIBRILLATION; HEMATOMA; HEMATURIA; HIP ARTHROPLASTY; HUMAN; KNEE ARTHROPLASTY; LABORATORY TEST; LIVER TOXICITY; LUNG EMBOLISM; OUTCOME ASSESSMENT; PHARMACODYNAMICS; RISK BENEFIT ANALYSIS; SECONDARY PREVENTION; SIDE EFFECT; SKIN HEMATOMA; STROKE; VENOUS THROMBOEMBOLISM; WOUND HEMATOMA;

ANTICOAGULANTS; BENZIMIDAZOLES; BETA-ALANINE; CLINICAL TRIALS AS TOPIC; HUMANS;

EID: 78649974862     PISSN: 15430790     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (33)

1. Hirsh J, Dalen J, Anderson DR, et al. Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest. 2001; 119: 8S-21S.
2. Ufer M. Comparative efficacy and safety of the novel oral anticoagulants dabigatran, rivaroxaban and apixaban in preclinical and clinical development. Thromb Haemost. 2010;103:572-585.
3. Eriksson BI, Smith H, Yasothan U, Kirkpatrick P. Dabigatran etexilate. Nat Rev Drug Discov. 2008;7:557-558.
4. Gurm HS, Bhatt DL. Thrombin, an ideal target for pharmacological inhibition: A review of direct thrombin inhibitors. Am Heart J. 2005;149:S43-S53.
5. Di Nisio M, Middeldorp S, Buller HR. Direct thrombin inhibitors. N Engl J Med. 2005;353: 1028-1040.
6. Blech S, Ebner T, Ludwig-Schwellinger E, Stangier J, Roth W. The metabolism and disposition of the oral direct thrombin inhibitor, dabigatran, in humans. Drug Metab Dispos. 2008;36: 386-399.
7. Stangier J, Clemens A. Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor. Clin Appl Thromb Hemost. 2009;15: 9S-16S.
8. Stangier J, Stahle H, Rathgen K, Fuhr R. Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects. Clin Pharmacokinet. 2008;47: 47-59.
9. Lassen MR. Recent developments in the use of oral anticoagulants. Expert Opin Pharmacother. 2009;10: 1769-1781.
10. Spyropoulos AC. Brave new world: the current and future use of novel anticoagulants. Thromb Res. 2008;123(Suppl 1):S29-35.
11. Turpie AG. New oral anticoagulants in atrial fibrillation. Eur Heart J. 2008;29:155-165.
12. Pradaxa (dabigatran etexilate) clinical trials. http://www.pradaxa.com/HCP/Home/clinical_trials/index.jsp.
13. Geerts W. Prevention of venous thromboembolism: a key patient safety priority. J Thromb Haemost. 2009;7: 1-8.
14. 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.
15. RE-MOBILIZE Writing Committee, Ginsberg JS, Davidson BL, 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.
16. 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: 2178-2185.
17. 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(9591): 949-956.
18. Wolowacz SE, Roskell NS, Plumb JM, Caprini JA, Eriksson BI. Efficacy and safety of dabigatran etexilate for the prevention of venous thromboembolism following total hip or knee arthroplasty. A meta-analysis. Thromb Haemost. 2009; 101: 77-85.
19. Eriksson BI, Friedman R. Dabigatran etexilate: pivotal trials for venous thromboembolism prophylaxis after hip or knee arthroplasty. Clin Appl Thromb Hemost. 2009;15(Suppl 1): 25S-31S.
20. Eikelboom JE, Weitz JI. Dabigatran etexilate for prevention of venous thromboembolism. Thromb Haemost. 2009; 101: 2-4.
21. 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.
22. Kearon C, Kahn SR, Agnelli G, et al. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133: 454S-545S.
23. Stafford RS, Singer DE. Recent national patterns of warfarin use in atrial fibrillation. Circulation. 1998;97:1231-1233.
24. Ezekowitz MD, Reilly PA, Nehmiz G, 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: 1419-1426.
25. Drews RE, Shulman LN. Update in hematology and oncology. Ann Intern Med. 2010;152: 655-662.
26. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009; 361: 1139-1151.
27. Oldgren J, Budaj A, Granger C, et al. Randomised dabigatran etexilate dose finding study in patients with acute coronary syndromes post index event with additional risk factors for cardiovascular complications also receiving aspirin and clopidogrel (RE-DEEM). 2009 late-breaking clinical Trial/Science abstracts from the AHA scientific sessions 2009. Circulation. 2009; 120: 2152-2161.
28. Levine MN. New antithrombotic drugs: potential for use in oncology. J Clin Oncol. 2009; 27: 4912-4918.
29. Sweetland S, Green J, Liu B, et al. Duration and magnitude of the postoperative risk of venous thromboembolism in middle aged women: prospective cohort study. BMJ. 2009; 339: b4583.
30. Faltas B. Prolonged and increased postoperative risk of venous thromboembolism: Rationale for even more 'extended' prophylaxis? Expert Rev Hematol. 2010; 3: 161-163. http://dx.doi.org/10.1586/ehm.10.6.
31. Gage BF. Can we rely on RE-LY? N Engl J Med. 2009; 361: 1200-1202.
32. Hankey GJ. At last, a RE-LYable alternative to warfarin for atrial fibrillation. Int J Stroke. 2009; 4: 454-455.
33. FDA Advisory Committee Unanimously Recommends Approval of Dabigatran Etexilate for Stroke Prevention in Atrial Fibrillation. http://us.boehringeringelheim.com/news_events/press_releases/press_release_archive/2010/september_20_20101.html. Accessed September 30, 2010.