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Dabigatran Etexilate: A Review in Nonvalvular Atrial Fibrillation

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Abstract

Dabigatran etexilate (Pradaxa®) is approved in the EU for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) and one or more risk factors. Dabigatran etexilate is a prodrug of dabigatran, a direct inhibitor of thrombin. In patients with NVAF in the phase III RE-LY trial, dabigatran etexilate dosages of 110 and 150 mg twice daily were noninferior to warfarin with regard to the risk of stroke or systemic embolism (primary efficacy endpoint). The higher dosage was associated with a significantly lower risk of stroke or systemic embolism than warfarin, with no significant between-group difference in the risk of major bleeding (primary safety endpoint). Both dosages of dabigatran etexilate were associated with significantly lower rates of haemorrhagic stroke, intracranial bleeding and life-threatening major bleeding than warfarin. Dabigatran etexilate was also effective and generally well tolerated across various patient subgroups. The efficacy and tolerability of dabigatran etexilate was maintained for up to 6.7 years in the RELY-ABLE extension study. Routine anticoagulation monitoring is not required in patients receiving dabigatran etexilate, and it is currently the only non-vitamin K antagonist oral anticoagulant (NOAC) with a specific reversal agent available. Although direct comparisons with other NOACs would be beneficial, dabigatran etexilate is a useful option for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

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References

  1. Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016. doi:10.1093/eurheartj/ehw210.

    Google Scholar 

  2. Patel A, Goddeau RP Jr, Henninger N. Newer oral anticoagulants: stroke prevention and pitfalls. Open Cardiovasc Med J. 2016;10:94–104.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Ahmad Y, Lip GY. Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: NICE guidance. Heart. 2012;98(19):1404–6.

    Article  CAS  PubMed  Google Scholar 

  4. Boehringer Ingelheim International GmbH. Pradaxa: summary of product characteristics. 2016. http://www.ema.europa.eu. Accessed 18 Jan 2017.

  5. Burness CB, McKeage K. Dabigatran etexilate: a review of its use for the prevention of venous thromboembolism after total hip or knee replacement surgery. Drugs. 2012;72(7):963–86.

    Article  CAS  PubMed  Google Scholar 

  6. Greig SL, McKeage K. Dabigatran etexilate: a review of its use in the treatment of acute venous thromboembolism and prevention of venous thromboembolism recurrence. Drugs. 2014;74(15):1785–800.

    Article  CAS  PubMed  Google Scholar 

  7. Garnock-Jones KP. Dabigatran etexilate: a review of its use in the prevention of stroke and systemic embolism in patients with atrial fibrillation. Am J Cardiovasc Drugs. 2011;11(1):57–72.

    Article  CAS  PubMed  Google Scholar 

  8. Wienen W, Stassen JM, Priepke H, et al. 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(1):155–62.

    CAS  PubMed  Google Scholar 

  9. 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.

    Article  CAS  PubMed  Google Scholar 

  10. Stangier J, Rathgen K, Stahle 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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. 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.

    Article  PubMed  Google Scholar 

  12. Siegbahn A, Oldgren J, Andersson U, et al. D-dimer and factor VIIa in atrial fibrillation—prognostic values for cardiovascular events and effects of anticoagulation therapy. A RE-LY substudy. Thromb Haemost. 2016;115(5):921–30.

    Article  PubMed  Google Scholar 

  13. Joseph P, Pare G, Wallentin L, et al. Dabigatran etexilate and reduction in serum apolipoprotein B. Heart. 2016;102(1):57–62.

    Article  CAS  PubMed  Google Scholar 

  14. Hijazi Z, Oldgren J, Andersson U, et al. Growth differentiation factor 15 is an independent marker of major bleeding risk in atrial fibrillation: insights from the RE-LY trial [abstract no. A257 plus poster]. In: European Society of Cardiology Congress. 2016.

  15. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.

    Article  CAS  PubMed  Google Scholar 

  16. Lehr T, Haertter S, Liesenfeld KH, et al. Dabigatran etexilate in atrial fibrillation patients with severe renal impairment: dose identification using pharmacokinetic modeling and simulation. J Clin Pharmacol. 2012;52(9):1373–8.

    Article  CAS  PubMed  Google Scholar 

  17. Stangier J, Rathgen K, Stahle H, et al. 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.

    Article  CAS  PubMed  Google Scholar 

  18. Stangier J, Stahle H, Rathgen K, et al. Pharmacokinetics and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor, are not affected by moderate hepatic impairment. J Clin Pharmacol. 2008;48(12):1411–9.

    Article  CAS  PubMed  Google Scholar 

  19. Hartter S, Yamamura N, Stangier J, et al. Pharmacokinetics and pharmacodynamics in Japanese and Caucasian subjects after oral administration of dabigatran etexilate. Thromb Haemost. 2012;107(2):260–9.

    Article  PubMed  Google Scholar 

  20. Stangier J, Rathgen K, Stahle H, et al. Coadministration of dabigatran etexilate and atorvastatin: assessment of potential impact on pharmacokinetics and pharmacodynamics. Am J Cardiovasc Drugs. 2009;9(1):59–68.

    Article  CAS  PubMed  Google Scholar 

  21. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139–51.

    Article  CAS  PubMed  Google Scholar 

  22. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363(19):1875–6.

    Article  CAS  PubMed  Google Scholar 

  23. Connolly SJ, Wallentin L, Yusuf S. Additional events in the RE-LY trial. N Engl J Med. 2014;371(15):1464–5.

    Article  PubMed  Google Scholar 

  24. Connolly SJ, Wallentin L, Ezekowitz MD, et al. The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study. Circulation. 2013;128(3):237–43.

    Article  CAS  PubMed  Google Scholar 

  25. Ezekowitz MD, Eikelboom J, Oldgren J, et al. Long-term evaluation of dabigatran 150 vs. 110 mg twice a day in patients with non-valvular atrial fibrillation. Europace. 2016;18(7):973–8.

    Article  PubMed  Google Scholar 

  26. Diener HC, Connolly SJ, Ezekowitz MD, et al. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol. 2010;9(12):1157–63.

    Article  CAS  PubMed  Google Scholar 

  27. Ezekowitz MD, Wallentin L, Connolly SJ, et al. Dabigatran and warfarin in vitamin K antagonist-naive and -experienced cohorts with atrial fibrillation. Circulation. 2010;122(22):2246–53.

    Article  CAS  PubMed  Google Scholar 

  28. Ferreira J, Ezekowitz MD, Connolly SJ, et al. Dabigatran compared with warfarin in patients with atrial fibrillation and symptomatic heart failure: a subgroup analysis of the RE-LY trial. Eur J Heart Fail. 2013;15(9):1053–61.

    Article  CAS  PubMed  Google Scholar 

  29. Hijazi ZMDP, Hohnloser SHMD, Oldgren JMDP, et al. Efficacy and safety of dabigatran compared with warfarin in relation to baseline renal function in patients with atrial fibrillation: a RE-LY (randomized evaluation of long-term anticoagulation therapy) trial analysis. Circulation. 2014;129(9):961–70.

    Article  CAS  PubMed  Google Scholar 

  30. Wallentin L, Yusuf S, Ezekowitz MD, et al. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet. 2010;376(9745):975–83.

    Article  CAS  PubMed  Google Scholar 

  31. 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.

    Article  CAS  PubMed  Google Scholar 

  32. Dans AL, Connolly SJ, Wallentin L, et al. Concomitant use of antiplatelet therapy with dabigatran or warfarin in the randomized evaluation of long-term anticoagulation therapy (RE-LY) trial. Circulation. 2013;127(5):634–40.

    Article  CAS  PubMed  Google Scholar 

  33. Hori M, Connolly SJ, Zhu J, et al. Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in Asians and non-Asians with atrial fibrillation. Stroke. 2013;44(7):1891–6.

    Article  CAS  PubMed  Google Scholar 

  34. Nagarakanti R, Wallentin L, Noack H, et al. Comparison of characteristics and outcomes of dabigatran versus warfarin in hypertensive patients with atrial fibrillation (from the RE-LY trial). Am J Cardiol. 2015;116(8):1204–9.

    Article  CAS  PubMed  Google Scholar 

  35. Oldgren JMDP, Alings MMDP, Darius HMDP, et al. Risks for stroke, bleeding, and death in patients with atrial fibrillation receiving dabigatran or warfarin in relation to the CHADS2 score: a subgroup analysis of the RE-LY trial. Ann Intern Med. 2011;155(10):660–7.

    Article  PubMed  Google Scholar 

  36. Hori M, Fukaya T, Kleine E, et al. Efficacy and safety of dabigatran etexilate vs. warfarin in Asian RE-LY patients according to baseline renal function or CHADS2 score. Circ J. 2015;79(10):2138–47.

    Article  PubMed  Google Scholar 

  37. Brambatti M, Darius H, Oldgren J, et al. Comparison of dabigatran versus warfarin in diabetic patients with atrial fibrillation: results from the RE-LY trial. Int J Cardiol. 2015;196:127–31.

    Article  PubMed  Google Scholar 

  38. Hori M, Connolly SJ, Ezekowitz MD, et al. Efficacy and safety of dabigatran vs. warfarin in patients with atrial fibrillation-sub-analysis in Japanese population in RE-LY trial. Circ J. 2011;75(4):800–5.

    Article  CAS  PubMed  Google Scholar 

  39. Nagarakanti R, Connolly S, Fraessdorf M, et al. Clinical outcomes of atrial fibrillation patients receiving digoxin in the RE-LY® trial [abstract no. 1188-351]. J Am Coll Cardiol. 2016;67(13 Suppl):802.

    Article  Google Scholar 

  40. Verdecchia P, Di Pasquale G, Reboldi G, et al. Effects of dabigatran versus warfarin in relation to left ventricular hypertrophy in atrial fibrillation [abstract no. 1268-351]. J Am Coll Cardiol. 2016;67(13 Suppl):884.

    Article  Google Scholar 

  41. 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 [abstract no. A4]. J Am Coll Cardiol. 2010;55(10 Suppl 1):E37–9.

  42. Ezekowitz MD, Nagarakanti R, Noack H, et al. Comparison of dabigatran and warfarin in patients with atrial fibrillation and valvular heart disease: the RE-LY trial. Circulation. 2016;134(8):589–98.

    Article  CAS  PubMed  Google Scholar 

  43. 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.

    Article  CAS  PubMed  Google Scholar 

  44. Lip GYH, Clemens A, Noack H, et al. Patient outcomes using the European label for dabigatran: a post-hoc analysis from the RE-LY database. Thromb Haemost. 2014;111(5):933–42.

    Article  CAS  PubMed  Google Scholar 

  45. Douketis JD, Healey JS, Brueckmann M, et al. Urgent surgery or procedures in patients taking dabigatran or warfarin: analysis of perioperative outcomes from the RE-LY trial. Thromb Res. 2016;139:77–81.

    Article  CAS  PubMed  Google Scholar 

  46. Larsen TB, Rasmussen LH, Skjoth 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.

    Article  CAS  PubMed  Google Scholar 

  47. Graham DJ, Reichman ME, Wernecke M, et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015;131(2):157–64.

    Article  CAS  PubMed  Google Scholar 

  48. Lauffenburger JC, Farley JF, Gehi AK, et al. Effectiveness and safety of dabigatran and warfarin in real-world US patients with non-valvular atrial fibrillation: a retrospective cohort study. J Am Heart Assoc. 2015;4(4):e001798.

  49. Chan YH, Yen KC, See LC, et al. Cardiovascular, bleeding, and mortality risks of dabigatran in Asians with nonvalvular atrial fibrillation. Stroke. 2016;47:441–9.

    Article  CAS  PubMed  Google Scholar 

  50. Avgil-Tsadok M, Jackevicius CA, Essebag V, et al. Dabigatran use in elderly patients with atrial fibrillation. Thromb Haemost. 2015;115(1):152–60.

    Article  PubMed  Google Scholar 

  51. Seeger JD, Bykov K, Bartels DB, et al. Safety and effectiveness of dabigatran and warfarin in routine care of patients with atrial fibrillation. Thromb Haemost. 2015;114(6):1277–89.

    Article  PubMed  Google Scholar 

  52. Villines TC, Schnee J, Fraeman K, et al. A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system. Thromb Haemost. 2015;114(6):1290–8.

    Article  PubMed  Google Scholar 

  53. 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.e1–5.

  54. Böhm M, Ezekowitz MD, Connolly SJ, et al. Changes in renal function in patients with atrial fibrillation: an analysis from the RE-LY trial. J Am Coll Cardiol. 2015;65(23):2481–93.

    Article  PubMed  Google Scholar 

  55. Eikelboom JW, Wallentin L, Connolly SJ, et al. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation. 2011;123(21):2363–72.

    Article  CAS  PubMed  Google Scholar 

  56. Hernandez I, Baik SH, Pinera A, et al. Risk of bleeding with dabigatran in atrial fibrillation. JAMA Intern Med. 2015;175(1):18–24.

    Article  PubMed  Google Scholar 

  57. Vaughan Sarrazin MS, Jones M, Mazur A, et al. Bleeding rates in Veterans Affairs patients with atrial fibrillation who switch from warfarin to dabigatran. Am J Med. 2014;127(12):1179–85.

    Article  CAS  PubMed  Google Scholar 

  58. Larsen TB, Gorst-Rasmussen A, Rasmussen LH, et al. Bleeding events among new starters and switchers to dabigatran compared with warfarin in atrial fibrillation. Am J Med. 2014;127(7):650–6.e5.

  59. Graham DJ, Reichman ME, Wernecke M, et al. Stroke, bleeding, and mortality risks in elderly Medicare beneficiaries treated with dabigatran or rivaroxaban for nonvalvular atrial fibrillation. JAMA Intern Med. 2016;176(11):1662–71.

    Article  PubMed  Google Scholar 

  60. Zint K, Kreuzer J. A methodological appraisal of recent real-world data publications on dabigatran. JAMA Intern Med. 2015;175(7):1244.

    Article  PubMed  Google Scholar 

  61. National Institute for Health and Care Excellence. Atrial fibrillation: management. 2014. https://www.nice.org.uk. Accessed 18 Jan 2017.

  62. Eikelboom JW, Hankey GJ. Is there really misuse and abuse of dabigatran? Med J Aust. 2013;198(7):358–9.

    Article  PubMed  Google Scholar 

  63. Eikelboom JW, Connolly SJ, Hart RG, et al. Balancing the benefits and risks of 2 doses of dabigatran compared with warfarin in atrial fibrillation. J Am Coll Cardiol. 2013;62(10):900–8.

    Article  CAS  PubMed  Google Scholar 

  64. Reilly PA, Lehr T, Haertter S, et al. The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). J Am Coll Cardiol. 2014;63(4):321–8.

    Article  CAS  PubMed  Google Scholar 

  65. Kakkar AK, Mueller I, Bassand JP, et al. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J. 2012;163(1):13–9.

    Article  PubMed  Google Scholar 

  66. Huisman MV, Lip GY, Diener HC, et al. Design and rationale of global registry on long-term oral antithrombotic treatment in patients with atrial fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014;167(3):329–34.

    Article  PubMed  Google Scholar 

  67. Camm AJ, Accetta G, Ambrosio G, et al. Evolving antithrombotic treatment patterns for patients with newly diagnosed atrial fibrillation. Heart. 2016. doi:10.1136/heartjnl-2016-309832.

    PubMed  Google Scholar 

  68. Huisman MV, Rothman KJ, Paquette M, et al. Antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation: the GLORIA-AF registry, phase II. Am J Med. 2015;128(12):1306–13.e1.

  69. Dzeshka MS, Lip GY. Non-vitamin K oral anticoagulants in atrial fibrillation: where are we now? Trends Cardiovasc Med. 2015;25(4):315–36.

    Article  CAS  PubMed  Google Scholar 

  70. Gorst-Rasmussen A, Skjoth F, Larsen TB, et al. Dabigatran adherence in atrial fibrillation patients during the first year after diagnosis: a nationwide cohort study. J Thromb Haemost. 2015;13(4):495–504.

    Article  CAS  PubMed  Google Scholar 

  71. Shore S, Carey EP, Turakhia MP, et al. Adherence to dabigatran therapy and longitudinal patient outcomes: insights from the veterans health administration. Am Heart J. 2014;167(6):810–7.

    Article  CAS  PubMed  Google Scholar 

  72. Hanley JP. Warfarin reversal. J Clin Pathol. 2004;57(11):1132–9.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  73. Syed YY. Idarucizumab: a review as a reversal agent for dabigatran. Am J Cardiovasc Drugs. 2016;16(4):297–304.

    Article  CAS  PubMed  Google Scholar 

  74. McKeage K. Dabigatran etexilate: a pharmacoeconomic review of its use in the prevention of stroke and systemic embolism in patients with atrial fibrillation. Pharmacoeconomics. 2012;30(9):841–55.

    Article  PubMed  Google Scholar 

  75. Finnish Medicines Agency. Use of idarucizumab as a specific antidote to dabigatran seems reasonable. 2015. https://www.fimea.fi. Accessed 18 Jan 2017.

  76. Scottish Medicines Consortium. Idarucizumab 2.5 g/50 mL solution for injection/infusion (Praxbind®). 2016. https://www.scottishmedicines.org.uk. Accessed 18 Jan 2017.

  77. Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955–62.

    Article  CAS  PubMed  Google Scholar 

  78. Caldeira D, Goncalves N, Ferreira JJ, et al. Tolerability and acceptability of non-vitamin K antagonist oral anticoagulants in atrial fibrillation: systematic review and meta-analysis. Am J Cardiovasc Drugs. 2015;15(4):259–65.

    Article  CAS  PubMed  Google Scholar 

  79. Cameron C, Coyle D, Richter T, et al. Systematic review and network meta-analysis comparing antithrombotic agents for the prevention of stroke and major bleeding in patients with atrial fibrillation. BMJ Open. 2014;4(6):e004301.

    Article  PubMed  PubMed Central  Google Scholar 

  80. Fu W, Guo H, Guo J, et al. Relative efficacy and safety of direct oral anticoagulants in patients with atrial fibrillation by network meta-analysis. J Cardiovasc Med. 2014;15(12):873–9.

    Article  CAS  Google Scholar 

  81. Mantha S, Ansell J. An indirect comparison of dabigatran, rivaroxaban and apixaban for atrial fibrillation. Thromb Haemost. 2012;108(3):476–84.

    Article  CAS  PubMed  Google Scholar 

  82. Skjoth F, Larsen TB, Rasmussen LH, et al. Efficacy and safety of edoxaban in comparison with dabigatran, rivaroxaban and apixaban for stroke prevention in atrial fibrillation. An indirect comparison analysis. Thromb Haemost. 2014;111(5):981–8.

    Article  PubMed  Google Scholar 

  83. Lip GYH, Verdecchia P, Tervonen T, et al. Comparison of oral anti-coagulants for stroke prevention in non-valvular atrial fibrillation: a multi-criteria decision analysis [abstract no. A35 plus poster]. In: European Society of Cardiology Congress. 2016.

  84. Abraham NS, Singh S, Alexander GC, et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study. BMJ. 2015;350:h1857.

    Article  PubMed  PubMed Central  Google Scholar 

  85. Chang HY, Zhou M, Tang W, et al. Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study. BMJ. 2015;350:h1585.

    Article  PubMed  PubMed Central  Google Scholar 

  86. Gorst-Rasmussen A, Lip GY, Bjerregaard Larsen T. Rivaroxaban versus warfarin and dabigatran in atrial fibrillation: comparative effectiveness and safety in Danish routine care. Pharmacoepidemiol Drug Saf. 2016;25:1236–44.

    Article  CAS  PubMed  Google Scholar 

  87. Hernandez I, Zhang Y. Comparing stroke and bleeding with rivaroxaban and dabigatran in atrial fibrillation: analysis of the US Medicare part D data. Am J Cardiovasc Drugs. 2016. doi:10.1007/s40256-016-0189-9.

    Google Scholar 

  88. Larsen TB, Skjoth F, Nielsen PB, et al. Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ. 2016;353:i3189.

    Article  PubMed  PubMed Central  Google Scholar 

  89. Lip GY, Keshishian A, Kamble S, et al. Real-world comparison of major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban, or warfarin. A propensity score matched analysis. Thromb Haemost. 2016;116(5):975–86.

    Article  PubMed  Google Scholar 

  90. Staerk L, Fosbol EL, Lip GY, et al. Ischaemic and haemorrhagic stroke associated with non-vitamin K antagonist oral anticoagulants and warfarin use in patients with atrial fibrillation: a nationwide cohort study. Eur Heart J. 2016. doi:10.1093/eurheartj/ehw496.

    PubMed  Google Scholar 

  91. Yao X, Abraham NS, Sangaralingham LR, et al. Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation. J Am Heart Assoc. 2016;5(6). doi:10.1161/JAHA.116.003725

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Acknowledgements

During the peer review process, the manufacturer of dabigatran etexilate was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Hannah A. Blair & Gillian M. Keating

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Hannah Blair and Gillian Keating are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

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The manuscript was reviewed by: D. Atar, Division of Cardiology, Department of Medicine, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway; H-C. Diener, Department of Neurology, University Hospital Essen, University of Duisburg-Essen, Germany; S. Goto, Department of Medicine (Cardiology), Tokai University School of Medicine, Isehara, Japan.

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Blair, H.A., Keating, G.M. Dabigatran Etexilate: A Review in Nonvalvular Atrial Fibrillation. Drugs 77, 331–344 (2017). https://doi.org/10.1007/s40265-017-0699-z

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