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Drug Profile

Dabigatran for the treatment of venous thromboembolism

References

  • Pollak AW, McBane RD. Succinct review of the new VTE prevention and management guidelines. Mayo Clin Proc 2014;89:394-408
  • ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to the global disease burden. J Thromb Haemost 2014;12:1580-90
  • Deitelzweig SB, Johnson BH, Lin J, et al. Prevalence of clinical venous thromboembolism in the USA: current trends and future projections. Am J Hematol 2011;86:217-20
  • Silverstein MD, Heit JA, Mohr DN, et al. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med 1998;158:585-93
  • Bleker SM, Coppens M, Middeldorp S. Sex, thrombosis and inherited thrombophilia. Blood Rev 2014;28:123-33
  • Zhu T, Martinez I, Emmerich J. Venous thromboembolism: risk factors for recurrence. Arterioscler Thromb Vasc Biol 2009;29:298-310
  • Noble S, Pasi J. Epidemiology and pathophysiology of cancer-associated thrombosis. Br J Cancer 2010;102(Suppl 1):S2-9
  • Mahmoodi BK, Gansevoort RT, Naess IA, et al. Association of mild to moderate chronic kidney disease with venous thromboembolism: pooled analysis of five prospective general population cohorts. Circulation 2012;126:1964-71
  • Heit JA, Silverstein MD, Mohr DN, et al. Predictors of survival after deep vein thrombosis and pulmonary embolism: a population-based, cohort study. Arch Intern Med 1999;159:445-53
  • Heit JA, Mohr DN, Silverstein MD, et al. Predictors of recurrence after deep vein thrombosis and pulmonary embolism: a population-based cohort study. Arch Intern Med 2000;160:761-8
  • Kahn SR, Ginsberg JS. The post-thrombotic syndrome: current knowledge, controversies, and directions for future research. Blood Rev 2002;16:155-65
  • Kearon C, Akl EA, Comerota AJ, et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012;141:e419S-94S
  • Toshner M, Pepke-Zaba J. Chronic thromboembolic pulmonary hypertension: time for research in pathophysiology to catch up with developments in treatment. Prime Rep 2014;6:38
  • Konstantinides SV, Torbicki A, Agnelli G, et al. 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J 2014;35:3033-3069k
  • Schulman S, Rhedin AS, Lindmarker P, et al. A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. Duration of Anticoagulation Trial Study Group. N Engl J Med 1995;332:1661-5
  • Baglin T, Luddington R, Brown K, et al. Incidence of recurrent venous thromboembolism in relation to clinical and thrombophilic risk factors: prospective cohort study. Lancet 2003;362:523-6
  • Garcia DA, Baglin TP, Weitz JI, et al. Parenteral anticoagulants: Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012;141:e24S-43S
  • Hirsh J, Raschke R. Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126:188S-203S
  • Nutescu E, Singh-Khalsa M. Treatment of venous thromboembolism: challenging the unfractionated heparin standard. Pharmacotherapy 2004;24:127S-31S
  • Buller HR, Davidson BL, Decousus H, et al. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med 2003;349:1695-702
  • Buller HR, Davidson BL, Decousus H, et al. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Ann Intern Med 2004;140:867-73
  • Ansell J, Hirsh J, Hylek E, et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest 2008;133:160S-98S
  • Holbrook AM, Pereira JA, Labiris R, et al. Systematic overview of warfarin and its drug and food interactions. Arch Intern Med 2005;165:1095-106
  • van Es N, Coppens M, Schulman S, et al. Direct oral anticoagulants compared with vitamin K antagonists for acute venous thromboembolism: evidence from phase 3 trials. Blood 2014;124:1968-75
  • Bauer KA. Pros and cons of new oral anticoagulants. Hematology Am Soc Hematol Educ Program 2013;2013:464-70
  • van Ryn J, Goss A, Hauel N, et al. The discovery of dabigatran etexilate. Front Pharmacol 2013;4:12
  • 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;98:155-62
  • van Ryn J, Hauel N, Waldmann L, et al. Dabigatran inhibits both clot-bound and fluid phase thrombin in vitro: Effects compared to heparin and hirudin. Blood 2007;110(11):3998
  • 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;64:292-303
  • Ring A, Rathgen K, Stangier J, et al. Dabigatran does not prolong the QT interval with supratherapeutic exposure: a thorough QT study in healthy subjects. Clin Drug Investig 2013;33:333-42
  • Blech S, Ebner T, Ludwig-Schwellinger E, et al. The metabolism and disposition of the oral direct thrombin inhibitor, dabigatran, in humans. Drug Metab Dispos 2008;36:386-99
  • Stangier J, Stahle H, Rathgen K, et al. Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects. Clin Pharmacokinet 2008;47:47-59
  • 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;49:259-68
  • 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;48:1411-19
  • Boehringer Ingelheim International GmbH. Summary of product characteristics: Pradaxa. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000829/WC500041059.pdf [Last accessed 26 November 2014]
  • Boehringer Ingelheim Pharmaceuticals Inc. Full prescribing information: Pradaxa. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s024lbl.pdf [Last accessed 24 January 2015]
  • 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;9:59-68
  • Hartter S, Sennewald R, Schepers C, et al. Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers. Eur J Clin Pharmacol 2013;69:327-39
  • Hartter S, Koenen-Bergmann M, Sharma A, et al. Decrease in the oral bioavailability of dabigatran etexilate after co-medication with rifampicin. Br J Clin Pharmacol 2012;74:490-500
  • Hartter S, Sennewald R, Nehmiz G, et al. Oral bioavailability of dabigatran etexilate (Pradaxa®) after co-medication with verapamil in healthy subjects. Br J Clin Pharmacol 2013;75:1053-62
  • Schulman S, Kearon C, Kakkar AK, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009;361:2342-52
  • Schulman S, Kakkar AK, Goldhaber SZ, et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation 2014;129:764-72
  • Schulman S, Kearon C, Kakkar AK, et al. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med 2013;368:709-18
  • Eriksson BI, Dahl OE, Buller HR, et al. A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial. J Thromb Haemost 2005;3:103-11
  • 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;100:1419-26
  • Fiessinger JN, Huisman MV, Davidson BL, et al. Ximelagatran vs low-molecular-weight heparin and warfarin for the treatment of deep vein thrombosis: a randomized trial. JAMA 2005;293:681-9
  • Middeldorp S, Prins MH, Hutten BA. Duration of treatment with vitamin K antagonists in symptomatic venous thromboembolism. Cochrane Database Syst Rev 2014;8:CD001367
  • Kakkos SK, Kirkilesis GI, Tsolakis IA. Editor’s Choice - efficacy and safety of the new oral anticoagulants dabigatran, rivaroxaban, apixaban, and edoxaban in the treatment and secondary prevention of venous thromboembolism: a systematic review and meta-analysis of phase III trials. Eur J Vasc Endovasc Surg 2014;48:565-75
  • Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med 2013;368:699-708
  • Romualdi E, Donadini MP, Ageno W. Oral rivaroxaban after symptomatic venous thromboembolism: The continued treatment study (EINSTEIN-extension study). Expert Rev Cardiovasc Ther 2011;9:841-4
  • Schulman S, Eriksson H, Goldhaber SZ, et al. Influence of age on the efficacy and safety of dabigatran versus warfarin for the treatment of acute venous thromboembolism: a pooled analysis Of RE-COVER and RE-COVER II. Blood 2013;122:2375
  • Schulman S, Eriksson H, Goldhaber SZ, et al. Influence of renal function on the efficacy and safety of dabigatran versus warfarin for the treatment of acute venous thromboembolism: a pooled analysis From RE-COVER and RE-COVER II. Blood 2013;122:212
  • Schulman S, Eriksson H, Kakkar A, et al. Influence of age and renal function on efficacy and safety of dabigatran versus warfarin for the treatment of acute venous thromboembolism: a pooled analysis of RE-COVER™ and RE-COVER™ II. Blood 2014;124(21):abstract 594
  • Schulman S, Eriksson H, Goldhaber SZ, et al. Influence of active cancer on the efficacy and safety of dabigatran versus warfarin for the treatment of acute venous thromboembolism: a pooled analysis from RE-COVER and RE-COVER II. Blood 2013;122:582
  • Schulman S, Eriksson H, Goldhaber SZ, et al. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism and thrombophilia: A pooled analysis of RE-COVER™ and RE-COVER™ II. Circulation 2014;130:A18594
  • Schulman S, Goldhaber SZ, Kearon C, et al. Treatment with dabigatran or warfarin in patients with venous thromboembolism and cancer. Thromb Haemost 2015;113. [Epub ahead of print]
  • Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013;369:799-808
  • Buller HR, Decousus H, Grosso MA, et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 2013;369:1406-15
  • Prins MH, Lensing AW, Bauersachs R, et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J 2013;11:21
  • Schulman S, Eriksson H, Goldhaber SZ, et al. Influence of thrombophilia on the efficacy of dabigatran versus warfarin for the extended treatment of acute venous thromboembolism in RE-MEDY™. Blood 2014;124(21):1544
  • Castellucci LA, Cameron C, Le GG, et al. Efficacy and safety outcomes of oral anticoagulants and antiplatelet drugs in the secondary prevention of venous thromboembolism: systematic review and network meta-analysis. BMJ 2013;347:f5133
  • Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51
  • 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;11:246-52
  • Nieuwlaat R, Healey JS, Ezekowitz M, et al. Management of dyspepsia symptoms on dabigatran during RELY-ABLE: long-term follow up study after RE-LY. Eur Heart J 2013;34:102
  • Schulman S, Eriksson H, Goldhaber SZ, et al. Major bleeding events with dabigatran versus warfarin in patients with acute venous thromboembolism: a pooled analysis of RE-COVER and RE-COVER II. J Thromb Haemost 2014;12(Suppl S1):62-3
  • Southworth MR, Reichman ME, Unger EF. Dabigatran and postmarketing reports of bleeding. N Engl J Med 2013;368:1272-4
  • Harper P, Young L, Merriman E. Bleeding risk with dabigatran in the frail elderly. N Engl J Med 2012;366:864-6
  • Pfeilschifter W, Luger S, Brunkhorst R, et al. The gap between trial data and clinical practice - an analysis of case reports on bleeding complications occurring under dabigatran and rivaroxaban anticoagulation. Cerebrovasc Dis 2013;36:115-19
  • Franck AJ, Bovio JA. Extended anticoagulation in venous thromboembolism. N Engl J Med 2013;368:2328-9
  • Clemens A, Fraessdorf M, Friedman J. Cardiovascular outcomes during treatment with dabigatran: comprehensive analysis of individual subject data by treatment. Vasc Health Risk Manag 2013;9:599-615
  • 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;131:157-64
  • 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;61:2264-73
  • Boehringer Ingelheim. Pradaxa® (dabigatran etexilate) now approved in more than 100 countries for stroke prevention in atrial fibrillation. Available from: www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/06_march_2014_dabigatranetexilate.html [Last accessed 3 February 2015]
  • Carrier M, Le GG, Cho R, et al. Dose escalation of low molecular weight heparin to manage recurrent venous thromboembolic events despite systemic anticoagulation in cancer patients. J Thromb Haemost 2009;7:760-5
  • Glund S, Moschetti V, Norris S, et al. A randomised study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of idarucizumab, a specific antidote to dabigatran. Thromb Haemost 2015;113. [Epub ahead of print]
  • Lu G, DeGuzman FR, Hollenbach SJ, et al. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nat Med 2013;19:446-51
  • Bristol-Myers Squibb/Pfizer EEIG. Summary of product characteristics: Eliquis. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf [Last accessed 3 February 2015]
  • Daiichi Sankyo Inc. Full prescribing information: Savaysa. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316lbl.pdf [Last accessed 3 February 2015]
  • Bayer Pharma AG. Summary of product characteristics: Xarelto. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108.pdf [Last accessed 3 February 2015]

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