Dabigatran for the prevention and treatment of thromboembolic disorders

References

• Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet 2008;47(5):285-95
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Quinlan DJ, Weitz JI. Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor xa inhibitors in development. Clin Pharmacokinet 2009;48(1):1-22
   PubMed Web of Science ®Google Scholar
• 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):1116-27
   PubMed Web of Science ®Google Scholar
• Hankey GJ, Eikelboom JW. Dabigatran etexilate: a new oral thrombin inhibitor. Circulation 2011;123(13):1436-50
   PubMed Web of Science ®Google Scholar
• Stangier J, Rathgen K, Stähle H, Mazur D. Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: an open-label, parallel-group, single-centre study. Clin Pharmacokinet 2010;49(4):259-68
   PubMed Web of Science ®Google Scholar
• Anderson FAJr, Spencer FA. Risk factors for venous thromboembolism. Circulation 2003;107(23 Suppl 1):I9-16
   PubMed Web of Science ®Google Scholar
• RE-MOBILIZE Writing Committee. Ginsberg JS, Davidson BL, Comp PC, 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):1-9
   Web of Science ®Google Scholar
• 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 RE-MODEL randomized trial. J Thromb Haemost 2007;5(11):2178-85
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Dahl OE, Huo MH, et al. RE-NOVATE II Study Group. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II). A randomized, double-blind, non-inferiority trial. Thromb Haemost 2011;105(4):721-9
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Dahl OE, Rosencher N, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomized, double-blind, non-inferiority trial. Lancet 2007;370(9591):949-56
   PubMed Web of Science ®Google Scholar
• Gómez-Outes A, Terleira-Fernández AI, Suárez-Gea ML, Vargas-Castrillón E. Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons. BMJ 2012;344:e3675
   PubMed Web of Science ®Google Scholar
• Schulman S, Kearon C, Kakkar AK, et al. RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009;361(24):2342-52
   PubMed Web of Science ®Google Scholar
• Schulman S, Kakkar AK, Goldhaber SZ, et al. RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation 2014;129(7):764-72
   PubMed Web of Science ®Google Scholar
• Beyer-Westendorf J, Ageno W. Benefit-risk profile of non-vitamin K antagonist oral anticoagulants in the management of venous thromboembolism. Thromb Haemost 2015;113(2):231-46
   Google Scholar
• Schulman S, Kearon C, Kakkar AK, et al. RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med 2013;368(8):709-18
   PubMed Web of Science ®Google Scholar
• 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):2370-5
   PubMed Web of Science ®Google Scholar
• European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery. Camm AJ, Kirchhof P, Lip GY, et al. ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace 2010;12(10):1360-420
   Google Scholar
• 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(12):857-67
   PubMed Web of Science ®Google Scholar
• Ansell J, Hollowell J, Pengo V, et al. Descriptive analysis of the process and quality of oral anticoagulation management in real-life practice in patients with chronic non-valvular atrial fibrillation: the international study of anticoagulation management (ISAM). J Thromb Thrombolysis 2007;23(2):83-91
   PubMedGoogle Scholar
• Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51
   PubMed Web of Science ®Google Scholar
• Salazar CA, del Aguila D, Cordova EG. Direct thrombin inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in people with non-valvular atrial fibrillation. Cochrane Database Syst Rev 2014;3:CD009893
   PubMed Web of Science ®Google Scholar
• 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):131-6
   PubMed Web of Science ®Google Scholar
• Yadlapati A, Groh C, Passman R. Safety of short-term use of dabigatran or rivaroxaban for direct-current cardioversion in patients with atrial fibrillation and atrial flutter. Am J Cardiol 2014;113(8):1362-3
   PubMed Web of Science ®Google Scholar
• Kochhäuser S, Khaykin Y, Beardsall J, et al. Comparison of outcomes after cardioversion or atrial fibrillation ablation in patients with differing periprocedural anticoagulation regimens. Can J Cardiol 2014;30(12):1541-6
   Google Scholar
• Camm AJ, Lip GY, De Caterina R, et al. ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation–developed with the special contribution of the European Heart Rhythm Association. Europace 2012;14(10):1385-413
   PubMed Web of Science ®Google Scholar
• Di Biase L, Burkhardt JD, Santangeli P, et al. Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial ibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial. Circulation 2014;129(25):2638-44
   PubMed Web of Science ®Google Scholar
• Bassiouny M, Saliba W, Rickard J, et al. Use of dabigatran for periprocedural anticoagulation in patients undergoing catheter ablation for atrial fibrillation. Circ Arrhythm Electrophysiol 2013;6(3):460-6
   PubMed Web of Science ®Google Scholar
• Kim JS, She F, Jongnarangsin K, et al. Dabigatran vs warfarin for radiofrequency catheter ablation of atrial fibrillation. Heart Rhythm 2013;10(4):483-9
   PubMed Web of Science ®Google Scholar
• Somani R, Mohajer K, Haley C, et al. The peri-procedural use of dabigatran in patients undergoing left atrial ablation for atrial fibrillation. Cardiovasc Ther 2014;32(5):198-201
   Google Scholar
• Lakkireddy D, Reddy YM, Di Biase L, et al. Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. J Am Coll Cardiol 2012;59(13):1168-74
   PubMed Web of Science ®Google Scholar
• Maddox W, Kay GN, Yamada T, et al. Dabigatran versus warfarin therapy for uninterrupted oral anticoagulation during atrial fibrillation ablation. J Cardiovasc Electrophysiol 2013;24(8):861-5
   PubMed Web of Science ®Google Scholar
• Hohnloser SH, Camm AJ. Safety and efficacy of dabigatran etexilate during catheter ablation of atrial fibrillation: a meta-analysis of the literature. Europace 2013;15(10):1407-11
   PubMed Web of Science ®Google Scholar
• Steinberg BA, Hasselblad V, Atwater BD, et al. Dabigatran for periprocedural anticoagulation following radiofrequency ablation for atrial fibrillation: a meta-analysis of observational studies. J Interv Card Electrophysiol 2013;37(3):213-21
   PubMed Web of Science ®Google Scholar
• Eikelboom JW, Connolly SJ, Brueckmann M, et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med 2013;369(13):1206-14
   PubMed Web of Science ®Google Scholar
• Bytzer P, Connolly SJ, Yang S, et al. Analysis of upper gastrointestinal adverse events among patients given dabigatran in the RE-LY trial. Clin Gastroenterol Hepatol 2013;11(3):246-52
   Google Scholar
• Nieuwlaat R, Healey JS, Ezekowits M, et al. Management of dyspepsia symptoms on dabigatran during RELY-ABLE: long-term follow up study after RE-LY (Poster). Eur Heart J 2013;34(Suppl 1):P549
   Google Scholar
• Hohnloser SH, Oldgren J, Yang S, et al. Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial. Circulation 2012;125(5):669-76
   PubMed Web of Science ®Google Scholar
• Uchino K, Hernandez AV. Dabigatran association with higher risk of acute coronary events: meta-analysis of noninferiority randomized controlled trials. Arch Intern Med 2012;172(5):397-402
   PubMed Web of Science ®Google Scholar
• Lip GY, Lane DA. Does warfarin for stroke thromboprophylaxis protect against MI in atrial fibrillation patients? Am J Med 2010;123(9):785-9
   PubMed Web of Science ®Google Scholar
• Atrial Fibrillation Investigators. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation: analysis of pooled data from five randomized controlled trials. Arch Intern Med 1994;154(13):1449-57
   PubMedGoogle Scholar
• Van der Meer FJM, Rosendaal FR, Van der Broucke JP, Briët E. Bleeding complications in oral anticoagulation therapy. An analysis of risk factors. Arch Intern Med 1993;153(13):1557-62
   PubMed Web of Science ®Google Scholar
• Jackson SL, Peterson GM, Vial JH, et al. Outcomes in the management of atrial fibrillation: clinical trial results can apply in practice. Intern Med J 2001;31(6):329-36
   Google Scholar
• Hart RG, Diener HC, Yang S, et al. Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with warfarin or dabigatran: the RE-LY trial. Stroke 2012;43(6):1511-17
   PubMed Web of Science ®Google Scholar
• Healey JS, Eikelboom J, Douketis J, et al. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial. Circulation 2012;126(3):343-8
   PubMed Web of Science ®Google Scholar
• Healey JS, Eikelboom J, Wallentin L, et al. Effect of age and renal function on the risks of stroke and major bleeding with dabigatran compared to warfarin: an analysis from the RE-LY study. J Am Coll Cardiol 2010;55(10s1):A4.E37-7
   Google Scholar
• Larsen TB, Rasmussen LH, Skjøth F, et al. Efficacy and safety of dabigatran etexilate and warfarin in “real-world” patients with atrial fibrillation: a prospective nationwide cohort study. J Am Coll Cardiol 2013;61(22):2264-73
   PubMed Web of Science ®Google Scholar
• Graham DJ, Reichman ME, Wernecke M, et al. Cardiovascular, bleeding, and mortality risks in elderly medicare patients treated with dabigatran or warfarin for non-valvular atrial fibrillation. Circulation 2015;131(2):157-64
   PubMed Web of Science ®Google Scholar
• Hernandez I, Baik SH, Piñera A, Zhang Y. Risk of bleeding with dabigatran in atrial fibrillation. JAMA Intern Med 2015;175(1):18-24
   PubMed Web of Science ®Google Scholar
• Douxfils J, Mullier F, Robert S, et al. Impact of dabigatran on a large panel of routine or specific coagulation assays. Laboratory recommendations for monitoring of dabigatran etexilate. Thromb Haemost 2012;107(5):985-97
   PubMed Web of Science ®Google Scholar
• Vilchez JA, Gallego P, Lip GY. Safety of new oral anticoagulant drugs: a perspective. Ther Adv Drug Saf 2014;5(1):8-20
   PubMedGoogle Scholar
• Skeppholm M, Hjemdahl P, Antovic JP, et al. On the monitoring of dabigatran treatment in “real life” patients with atrial fibrillation. Thromb Res 2014;134(4):783-9
   Google Scholar
• Stangier J, Rathgen K, Stähle H, et al. 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
   PubMed Web of Science ®Google Scholar
• Antovic JP, Skeppholm M, Eintrei J, et al. Evaluation of coagulation assays versus LC-MS/MS for determinations of dabigatran concentrations in plasma. Eur J Clin Pharmacol 2013;69(11):1875-81
   PubMed Web of Science ®Google Scholar
• van Ryn J, Sieger P, Kink-Eiband M, et al. Adsorption of dabigatran etexilate in water or dabigatran in pooled human plasma by activated charcoal in vitro [abstract no. 1065]. In: 51st ASH Annual Meeting and Exposition; American Society of Hematology New Orleans, LA; 2009
   Google Scholar
• Zhou W, Schwarting S, Illanes S, et al. Hemostatic therapy in experimental intracerebral hemorrhage associated with the direct thrombin inhibitor dabigatran. Stroke 2011;42(12):3594-9
   PubMed Web of Science ®Google Scholar
• 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(2):217-24
   PubMed Web of Science ®Google Scholar
• 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(14):1573-9
   PubMed Web of Science ®Google Scholar
• van Ryn J, Ruehl D, Priepke H, et al. Reversibility of the anticoagulant effect of high doses of the direct thrombin inhibitor dabigatran, by recombinant Factor VIIa or activated prothrombin complex concentrate (abstract 0370). Haematologica 2008;93(Suppl 1):148
   Google Scholar
• Warkentin TE, Margetts P, Connolly SJ, et al. Recombinant factor VIIa (rFVIIa) and hemodialysis to manage massive dabigatran-associated postcardiac surgery bleeding. Blood 2012;119(9):2172-4
   PubMed Web of Science ®Google Scholar
• Elg M, Carlsson S, Gustafsson D. Effects of agents, used to treat bleeding disorders, on bleeding time prolonged by a very high dose of a direct thrombin inhibitor in anesthesized rats and rabbits. Thromb Res 2001;101(3):159-70
   Google Scholar
• Enriquez A, Lip G, Baranchuk A. Anticoagulation reversal in the era of non-vitamin K oral anticoagulants (NOACs). Europace 2015. [Epub ahead of print]
   Google Scholar
• Schiele F, van Ryn J, Canada K, et al. A specific antidote for dabigatran: functional and structural characterization. Blood 2013;121(18):3554-62
   PubMed Web of Science ®Google Scholar
• Glund S, Stangier J, Schmohl M, et al. A specific antidote for dabigatran: immediate, complete and sustained reversal of dabigatran induced anticoagulation in healthy male volunteers (abstract). Circulation 2013;128:A17765
   Web of Science ®Google Scholar
• Laulicht B, Bakhru S, Lee C, et al. Small molecule antidote for anticoagulants (abstract). Circulation 2012;126:10021
   Google Scholar
• Heidbuchel H, Verhamme P, Alings M, et al. EHRA practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary. Eur Heart J 2013;34(27):2094-106
   PubMed Web of Science ®Google Scholar
• Spyropoulos AC, Douketis JD. How I treat anticoagulated patients undergoing an elective procedure or surgery. Blood 2012;120(15):2954-62
   PubMed Web of Science ®Google Scholar
• You JJ, Singer DE, Howard PA, et al. American College of Chest Physicians. Antithrombotic therapy for atrial fibrillation: antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141(2 Suppl):e531S-75S
   PubMed Web of Science ®Google Scholar
• Skanes AC, Healey JS, Cairns JA, et al. Canadian Cardiovascular Society Atrial Fibrillation Guidelines Committee. Focused 2012 update of the Canadian Cardiovascular Society atrial fibrillation guidelines: recommendations for stroke prevention and rate/rhythm control. Can J Cardiol 2012;28(2):125-36
   PubMed Web of Science ®Google Scholar
• Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation 2011;123(22):2562-70
   PubMed Web of Science ®Google Scholar
• Freeman JV, Turakhia MP. Dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med 2011;154(1):570-1
   Google Scholar
• Kamel H, Johnston SC, Easton JD, Kim AS. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in patients with atrial fibrillation and prior stroke or transient ischemic attack. Stroke 2012;43(3):881-3
   PubMed Web of Science ®Google Scholar
• Lip GY, Larsen TB, Skjøth F, Rasmussen LH. Indirect comparisons of new oral anticoagulant drugs for efficacy and safety when used for stroke prevention in atrial fibrillation. J Am Coll Cardiol 2012;60(8):738-46
   PubMed Web of Science ®Google Scholar
• Birnie DH, Healey JS, Wells GA, et al. BRUISE CONTROL Investigators. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med 2013;368(22):2084-93
   PubMed Web of Science ®Google Scholar
• Ottawa Heart Institute Research Corp. Strategy of continued versus interrupted dabigatran at time of device surgery in patients with moderate to high risk of arterial thromboembolic events (BRUISE CONTROL 2). NLM identifier: NCT01675076. Available from: https://clinicaltrials.gov/ct2/show/NCT01675076
   Google Scholar
• Boehringer Ingelheim. Pradaxa study in non-valvular atrial fibrillation patients with severely impaired renal function. NLM identifier: NCT01896297. Available from: https://clinicaltrials.gov/ct2/show/NCT01896297
   Google Scholar
• Boehringer Ingelheim. Evaluation of dual therapy with dabigatran vs. triple therapy with warfarin in patients with AF that undergo a PCI with stenting (REDUAL-PCI). NLM identifier: NCT02164864. Available from: http://clinicaltrials.gov/ct2/show/NCT02164864
   Google Scholar
• Skanes A. DAPPAR AF Dabigatran for periprocedural anticoagulation during radiofrequency ablation of atrial fibrillation (DAPPARAF). NLM identifier: NCT01468155. Available from: http://clinicaltrials.gov/ct2/show/NCT01468155
   Google Scholar
• Nickenig G. Prevention of silent cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation (ODIn-AF). NLM Identifier: NCT02067182. Available from: http://clinicaltrials.gov/ct2/show/NCT02067182
   Google Scholar
• Vanderbilt University. Use of dabigatran etexilate to prevent stroke and thromboembolism. NLM Identifier: NCT01976507 Available from: http://clinicaltrials.gov/ct2/show/NCT01976507
   Google Scholar
• Boehringer Ingelheim. Open label study comparing efficacy and safety of dabigatran etexilate to standard of care in paediatric patients with venous thromboembolism (VTE). NLM Identifier: NCT01895777 Available from: https://clinicaltrials.gov/ct2/show/NCT01895777
   Google Scholar
• Hospital Ana Nery. Dabigatran versus warfarin after mitral and/or aortic bioprosthesis replacement and atrial fibrillation postoperatively (DAWA). NLM Identifier: NCT01868243 Available from: http://clinicaltrials.gov/ct2/show/NCT01868243
   Google Scholar
• Available from: www.gloria-af.com
   Google Scholar
• Available from: www.tri-london.ac.uk/garfield
   Google Scholar