Dabigatran: Comparison to warfarin, pathway to approval, and practical guidelines for use

Journal of Cardiovascular Pharmacology and Therapeutics

Volumn 17, Issue 3, 2012, Pages 237-247

  Iyer, Vivek ^a   Singh, Harsimran S ^a   Reiffel, James A ^a  

^a NewYork Presbyterian Hospital   (United States)

Author keywords

atrial fibrillation; cardiac pharmacology; heart disease; nonantiarrhythmic; stroke

Indexed keywords

ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; APIXABAN; BETRIXABAN; DABIGATRAN; DABIGATRAN ETEXILATE; EDOXABAN; ENOXAPARIN; HEPARIN; QUINIDINE; RIVAROXABAN; WARFARIN;

ACUTE CORONARY SYNDROME; ANTICOAGULANT THERAPY; BLEEDING; BRAIN HEMORRHAGE; CARDIOVERSION; COST EFFECTIVENESS ANALYSIS; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; GASTROINTESTINAL HEMORRHAGE; HEART ATRIUM FIBRILLATION; HIGH RISK PATIENT; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; STROKE; THROMBOEMBOLISM;

ANTITHROMBINS; ATRIAL FIBRILLATION; BENZIMIDAZOLES; HUMANS; PYRIDINES; STROKE; THROMBOSIS; WARFARIN;

EID: 84862591479     PISSN: 10742484     EISSN: 19404034     Source Type: Journal    
DOI: 10.1177/1074248412436608     Document Type: Review

References (42)

1. Naccarelli GV, Varker H, Lin J, Schulman KL. Increasing prevalence of atrial fibrillation and flutter in the United States. Am J Cardiol. 2009 ; 104 (11). 1534-1539
2. 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 (18). 2370-2375 (Pubitemid 32424106)
3. 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 (19). 2369-2429
4. Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: 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): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 ; 114 (7). e257 - e354
5. Wann LS, Curtis AB, Ellenbogen KA, et al. 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran) A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Heart Rhythm. 2011 ; 8 (3). e1 - e8
6. Gage BF, Waterman AD, Shannon W, et al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001 ; 285 (22). 2864-2870 (Pubitemid 32537350)
7. Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. 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
8. Pisters R, Lane DA, Nieuwlaat R, et al. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 ; 138: 1093-1100
9. Ostermayer SH, Reisman M, Kramer PH, et al. Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials. J Am Coll Cardiol. 2005 ; 46: 9-14 (Pubitemid 40905122)
10. Rost S, Fregin A, Ivaskevicius V, et al. Mutations in VKORC1 cause warfarin resistance and multiple coagulation factor deficiency type 2. Nature. 2004 ; 427 (6974). 537-541 (Pubitemid 38209110)
11. Furie B, Furie BC. Mechanisms of thrombus formation. N Engl J Med. 2008 ; 359 (9). 938-949
12. Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation. 2011 ; 123 (22). 2562-2570
13. Dezee KJ, Shimeall WT, Douglas KM, Shumway NM, O'Malley PG. Treatment of excessive anticoagulation with phytonadione (vitamin K): a meta-analysis. Arch Intern Med. 2006 ; 166 (4). 391-397
14. Hart RG, Benavente O, McBride R, Pearce LA. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Intern Med. 1999 ; 131 (7). 492-501 (Pubitemid 29482392)
15. Gage BF. Can we rely on RE-LY?. N Engl J Med. 2009 ; 361 (12). 1200-1202
16. Bungard TJ, Ghali WA, Teo KK, McAlister FA, Tsuyuki RT. Why do patients with atrial fibrillation not receive warfarin?. Arch Intern Med. 2000 ; 160 (1). 41-46 (Pubitemid 30040971)
17. Klein TE, Altman RB, Eriksson N, et al. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med. 2009 ; 360 (8). 753-764
18. Albers GW, Diener HC, Frison L, et al. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. JAMA. 2005 ; 293 (6). 690-698
19. 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 (9526). 1903-1912
20. European Medicines Agency PO. Press Release: AstraZeneca withdraws its application for ximelagatran 36-mg film-coated tablets. 2006; http://www.ema.europa.eu/docs/en-GB/document-library/Press-release/2010/02/ WC500074073.pdf. Accessed July 23, 2011.
21. AstraZeneca. AstraZeneca receives action letter from FDA for Exanta (ximelagatran). 2004; http://www.astrazeneca.com/Media/Press-releases/Article/ 20041011 - ASTRAZENECA-RECEIVES-ACTION-LETTER-FROM-FDA-FOR-EXANT. Accessed July 23, 2011.
22. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 ; 361 (12). 1139-1151
23. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L. Newly identified events in the RE-LY trial. N Engl J Med. 2010 ; 363 (19). 1875-1876
24. Patel MR. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010 ; 159 (3). 340-347 e341
25. Connolly S, Ezekowitz M R D, SH H P D. A phase 2, randomized, parallel group, dose-finding, multicenter, multinational study of the safety, tolerability and pilot efficacy of three blinded doses of the oral factor Xa inhibitor betrixaban compared with open-label dose-adjusted warfarin in patients with non-valvular atrial fibrillation (EXPLORE-Xa). Paper presented at: American College of Cardiology (ACC) 59th Annual Scientific Session 2010 ; Atlanta, GA ;..
26. Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 ; 364 (9). 806-817
27. 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 AF-TIMI 48). Am Heart J. 2010 ; 160 (4). 635-641
28. Lopes RD, Alexander JH, Al-Khatib SM, et al. Apixaban for reduction in stroke and other ThromboemboLic events in atrial fibrillation (ARISTOTLE) trial: design and rationale. Am Heart J. 2010 ; 159 (3). 331-339
29. US Food and Drug Administration. FDA approves Pradaxa to prevent stroke in people with atrial fibrillation. 2010. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm230241.htm. Accessed March 1, 2011.
30. Viles-Gonzalez JF, Reddy VY, Petru J, et al. Incomplete occlusion of the LAA with the PLAATO device is not associated with increased risk of stroke. J Interv Card Electrophysiol. 2012 ; 33 (1). 69-75
31. van Ryn J, Stangier J, Haertter S, et al. Dabigatran etexilate-a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost. 2010 ; 103 (6). 1116-1127
32. 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 (9). 1419-1426 (Pubitemid 47576022)
33. 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 (3). 292-303 (Pubitemid 47283865)
34. Eriksson BI, Dahl OE, Ahnfelt L, 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 (9). 1573-1580 (Pubitemid 40186173)
35. Klein AL, Grimm RA, Murray RD, et al. Assessment of Cardioversion Using Transesophageal Echocardiography Investigators. Use of transesophageal echocardiography to guide cardioversion in patients with atrial fibrillation. N Engl J Med.. 2001 ; 344 (19). 1411-1420 (Pubitemid 32402097)
36. 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 (2). 131-136
37. Lip GY, Lane DA. Does warfarin for stroke thromboprophylaxis protect against MI in atrial fibrillation patients?. Am J Med. 2010 ; 123 (2). 785-789
38. Beasley BN, Unger EF, Temple R. Anticoagulant options-why the FDA approved a higher but not a lower dose of dabigatran. N Engl J Med. 2011 ; 364 (19). 1788-1790
39. Bayard YL, Omran H, Neuzil P, et al. PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients: results from the European PLAATO study. EuroIntervention. 2010 ; 6 (2). 220-226
40. Safety Information and Adverse Event Reporting System F. Multaq (dronedarone hydrochloride) Tablets. 2011; http://www.fda.gov/Safety/MedWatch/ SafetyInformation/ucm243762.htm. Accessed July 23, 2011.
41. Freeman JV, Zhu RP, Owens DK, et al. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med. 2011 ; 154 (1). 1-11
42. Sorensen SV, Kansal AR, Connolly S, et al. Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: a Canadian payer perspective. Thromb Haemost. 2011 ; 105 (5). 908-919