A new approach with anticoagulant development: tailoring anticoagulant therapy with dabigatran etexilate according to patient risk

Bibliography

• Geerts WH, Bergqvist D, Pineo GF, Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th edition. Chest 2008;133:381S-453S
   PubMedGoogle Scholar
• Dahl OE, Caprini JA, Colwell CW Jr, Fatal vascular outcomes following major orthopedic surgery. Thromb Haemost 2005;93:860-96
   PubMed Web of Science ®Google Scholar
• Friedman RJ, Dahl OE, Rosencher N, for the RE-MOBILIZE, RE-MODEL, Re-NOVATE Steering Committees. Dabigatran versus enoxaparin for prevention of venous thromboembolism after hip or knee arthroplasty. A pooled analysis of three trials. Thromb Res 2010;126:175-82
   PubMed Web of Science ®Google Scholar
• Schulman S, Beyth RJ, Kearon C, Levine MN. Hemorrhagic complications of anticoagulant and thrombolytic treatment: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th edition. Chest 2008;133:257S-98S
   PubMed Web of Science ®Google Scholar
• Mismetti P, Laporte S, Zufferey P, Prevention of venous thromboembolism in orthopedic surgery with vitamin K antagonists: a meta-analysis. J Thromb Haemost 2004;2:1058-70
   PubMed Web of Science ®Google Scholar
• Arixtra European Public Assessment Report. Scientific Discussion. European Medicines Agency, 2004. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000403/WC500027737.pdf [Last accessed 24 August 2011]
   Google Scholar
• Lotke PA, Lonner JH. Deep venous thrombosis prophylaxis: better living through chemistry—in opposition. J Arthroplasty 2005;20(Suppl 2):15-17
   PubMed Web of Science ®Google Scholar
• Eikelboom JW, Quinlan DJ, O'Donnell M. Major bleeding, mortality, and efficacy of fondaparinux in venous thromboembolism prevention trials. Circulation 2009;120:2006-11
   PubMed Web of Science ®Google Scholar
• Cohen AT, Tapson VF, Bergmann JF, ENDORSE Investigators. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet 2008;2:387-94
   Web of Science ®Google Scholar
• Arcelus JI, Monreal M, Caprini JA, RIETE investigators. Clinical presentation and time-course of postoperative venous thromboembolism: results from the RIETE registry. Thromb Haemost 2008;99:546-51
   PubMed Web of Science ®Google Scholar
• Lim W. Using low molecular weight heparin in special patient populations. J Thromb Thrombolysis 2010;29:233-40
   PubMed Web of Science ®Google Scholar
• Lacut K, Le Gal G, Mottier D. Primary prevention of venous thromboembolism in elderly medical patients. Clin Interv Aging 2008;3:399-411
   PubMed Web of Science ®Google Scholar
• Hauel NH, Nar H, Priepke H, Structure-based design of novel potent nonpeptide thrombin inhibitors. J Med Chem 2002;45:1757-66
   PubMed Web of Science ®Google Scholar
• Wienen W, Stassen JM, Priepke H, 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
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Dahl OE, Rosencher N, 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;5:2178-85
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Dahl OE, Rosencher N, Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet 2007;370:949-56
   PubMed Web of Science ®Google Scholar
• Schulman S, Kearon C, Kakkar AK, Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009;361:2342-52
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Dahl OE, Huo MH, the RE-NOVATE II Study Group. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II). A randomised, double-blind, non-inferiority trial. Thromb Haemost 2011;105:721-9
   PubMed Web of Science ®Google Scholar
• Ginsberg JS, Davidson BL, Comp PC, 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
   PubMed Web of Science ®Google Scholar
• Dahl OE. Dabigatran etexilate: an oral direct thrombin inhibitor. Therapy 2008;5:685-95
   Google Scholar
• Pradaxa® Summary of Product Characteristics. Boehringer Ingelheim International GmbH, D-55216 Ingelheim am Rhein, Germany, 2011. Available from: http://www.emc.medicines.org.uk/medicine/20760/SPC/Pradaxa+110+mg+hard+capsules/ [Last accessed 24 August 2011]
   Google Scholar
• Eriksson BI, Dahl OE, Ahnfelt L, 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;2:1573-80
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Dahl OE, Buller HR, 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
   PubMed Web of Science ®Google Scholar
• Connolly SJ, Ezekowitz MD, Yusuf S, RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Borris LC, Friedman RJ, Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008;358:2765-75
   PubMed Web of Science ®Google Scholar
• Kakkar AK, Brenner B, Dahl OE, Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet 2008;372:31-9
   PubMed Web of Science ®Google Scholar
• Lassen MR, Ageno W, Borris LC, Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008;358:2776-86
   PubMed Web of Science ®Google Scholar
• Turpie AG, Lassen MR, Davidson BL, Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009;373:1673-80
   PubMed Web of Science ®Google Scholar
• Turpie AG. Rivaroxaban for the prevention and treatment of venous thromboembolism. Fundam Clin Pharmacol 2011; [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• Abdulsattar Y, Bhambri B, Nogid A. Rivaroxaban (Xarelto) for the prevention of thromboembolic disease: an inside look at the oral direct factor Xa inhibitor. Pharm Ther 2009;34:238-44
   Google Scholar
• Dahl OE, Kurth AA, Rosencher N, No difference detected in efficacy of dabigatran etexilate when initial dosing was delayed: a post hoc analysis of pooled data from the European pivotal phase III trials. J Bone Joint Surg 2009;92-B(SUPPIV):494
   Google Scholar
• Mueck W, Borris LC, Dahl OE, Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Haemost 2008;100:453-61
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Mueck W, Zuehlsdorf M. The effect of extreme age, and gender, on the pharmacology and tolerability of rivaroxaban, an oral, direct factor Xa inhibitor. Annual Meeting of the American Society of Hematology (Abstracts). Blood 2006;108:905
   Web of Science ®Google Scholar
• Food and Drug Administration. Xarelto approval letter. November 2, 2011
   Google Scholar
• Patel MR, Mhaqffey KW, Garg JMS, Rivaroxaban versus warfarin in nonvalvular atrial fibrillation, ROCKET-AF trial. N Engl J Med 2011;365:883-91
   PubMed Web of Science ®Google Scholar
• Lassen MR, Raskob GE, Gallus A, Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet 2010;375:807-15
   PubMed Web of Science ®Google Scholar
• Lassen MR, Gallus A, Raskob GE, Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med 2010;363:2487-98
   PubMed Web of Science ®Google Scholar
• Huisman MV, Quinlan DJ, Dahl OE, Schulman S. Enoxaparin versus dabigatran or rivaroxaban for thromboprophylaxis after hip or knee arthroplasty: results of separate pooled analyses of phase III multicenter randomized trials. Circ Cardiovasc Qual Outcomes 2010;3:652-60
   PubMed Web of Science ®Google Scholar
• Granger CB, Alexander JH, McMurray JJ, Apixaban versus warfarin in patients with atrial fibrillation, ARISTOTLE trial. N Engl J Med 2011;365:981-92
   PubMed Web of Science ®Google Scholar
• Vera-Llonch M, Hagiwara M, Oster G. Clinical and economic consequences of bleeding following major orthopedic surgery. Thromb Res 2006;117:569-77
   PubMed Web of Science ®Google Scholar
• Rosencher N, Vielpeau C, Emmerich J, ESCORTE group. Venous thromboembolism and mortality after hip fracture surgery: the ESCORTE study. J Thromb Haemost 2005;3:2006-14
   PubMed Web of Science ®Google Scholar
• Lie SA, Engesaeter LB, Havelin LI, Early postoperative mortality after 67,548 total hip replacements: causes of death and thromboprophylaxis in 68 hospitals in Norway from 1987 to 1999. Acta Orthop Scand 2002;73:392-9
   PubMed Web of Science ®Google Scholar
• Thaler HW, Roller RE, Greiner N, Thromboprophylaxis with 60 mg enoxaparin is safe in hip trauma surgery. J Trauma 2001;51:518-21
   PubMedGoogle Scholar
• Eriksson BI, Bauer KA, Lassen MR, Turpie AG; Steering Committee of the Pentasaccharide in Hip-Fracture Surgery Study. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after hip-fracture surgery. N Engl J Med 2001;345:1298-304
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Agnelli G, Cohen AT, EXPRESS Study Group. The direct thrombin inhibitor melagatran followed by oral ximelagatran compared with enoxaparin for the prevention of venous thromboembolism after total hip or knee replacement: the EXPRESS study. J Thromb Haemost 2003;1:2490-6
   PubMed Web of Science ®Google Scholar
• Bjornara BT, Gudmundsen TE, Dahl OE. Frequency and timing of clinical venous thromboembolism after major joint surgery. J Bone Joint Surg Br 2006;88:386-91
   PubMed Web of Science ®Google Scholar
• Foss NB, Kristensen MT, Jensen PS, The effects of liberal versus restrictive transfusion thresholds on ambulation after hip fracture surgery. Transfusion 2009;49:227-34
   PubMed Web of Science ®Google Scholar
• Mantilla CB, Horlocker TT, Schroeder DR, Frequency of myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or knee arthroplasty. Anesthesiology 2002;96:1140-6
   PubMed Web of Science ®Google Scholar
• Devereaux PJ, Xavier D, Pogue J, POISE (PeriOperative ISchemic Evaluation) Investigators. Characteristics and short-term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery: a cohort study. Ann Intern Med 2011;154:523-8
   PubMed Web of Science ®Google Scholar
• Gerlach AT, Pickworth KK, Seth SK, Enoxaparin and bleeding complications: a review in patients with and without renal insufficiency. Pharmacotherapy 2000;20:771-5
   PubMed Web of Science ®Google Scholar
• Pola E, Papaleo P, Santoliquido A, Clinical factors associated with an increased risk of perioperative blood transfusion in nonanemic patients undergoing total hip arthroplasty. J Bone Joint Surg Am 2004;86-A:57-61
   Web of Science ®Google Scholar
• Turpie AG, Lensing AW, Fuji T, Boyle DA. Pharmacokinetic and clinical data supporting the use of fondaparinux 1.5 mg once daily in the prevention of venous thromboembolism in renally impaired patients. Blood Coagul Fibrinolysis 2009;20:114-21
   PubMed Web of Science ®Google Scholar
• Cadroy Y, Pourrat J, Baladre MF, Delayed elimination of enoxaparin in patients with chronic renal insufficiency. Thromb Res 1991;63:385-90
   PubMed Web of Science ®Google Scholar
• Goudable C, Saivin S, Houin G, Pharmacokinetics of a low molecular weight heparin (Fraxiparine) in various stages of chronic renal failure. Nephron 1991;59:543-5
   PubMed Web of Science ®Google Scholar
• Sanderink GJ, Guimart CG, Ozoux ML, Pharmacokinetics and pharmacodynamics of the prophylactic dose of enoxaparin once daily over 4 days in patients with renal impairment. Thromb Res 2002;105:225-31
   PubMed Web of Science ®Google Scholar
• Stobe J, Siegemund A, Achenbach H, Evaluation of the pharmacokinetics of dalteparin in patients with renal insufficiency. Int J Clin Pharmacol Ther 2006;44:455-65
   PubMed Web of Science ®Google Scholar
• Mahe I, Aghassarian M, Drouet L, Tinzaparin and enoxaparin given at prophylactic dose for eight days in medical elderly patients with impaired renal function: a comparative pharmacokinetic study. Thromb Haemost 2007;97:581-6
   PubMed Web of Science ®Google Scholar
• Mahe I, Gouin-Thibault I, Drouet L, Elderly medical patients treated with prophylactic dosages of enoxaparin: influence of renal function on anti-Xa activity level. Drugs Aging 2007;24:63-71
   PubMed Web of Science ®Google Scholar
• Delavenne X, Zufferey P, Baylot D, GETHCAM Study Group; POP-A-RIX Investigators. Population pharmacokinetics of fondaparinux administered at prophylactic doses after major orthopaedic surgery in everyday practice. Thromb Haemost 2010;104:252-60
   PubMed Web of Science ®Google Scholar
• Levin A, Ben-Artzi M, Beckerman P, Factors associated with bleeding in elderly hospitalized patients treated with enoxaparin sodium: a prospective, open-label, observational study. Drugs Aging 2009;26:77-85
   PubMed Web of Science ®Google Scholar
• Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41
   PubMed Web of Science ®Google Scholar
• Hutten BA, Lensing AW, Kraaijenhagen RA, Prins MH. Safety of treatment with oral anticoagulants in the elderly: a systematic review. Drugs Aging 1999;14:303-12
   PubMed Web of Science ®Google Scholar
• Pengo V, Legnani C, Noventa F, Palareti G; ISCOAT Study Group. (Italian Study on Complications of Oral Anticoagulant Therapy). Oral anticoagulant therapy in patients with non-rheumatic atrial fibrillation and risk of bleeding. Thromb Haemost 2001;85:418
   PubMed Web of Science ®Google Scholar
• Fang MC, Chang Y, Hylek EM, Advanced age, anticoagulation intensity, and risk for intracranial hemorrhage among patients taking warfarin for atrial fibrillation. Ann Intern Med 2004;141:745-52
   PubMed Web of Science ®Google Scholar
• Johnson CE, Lim WK, Workman BS. People aged over 75 in atrial fibrillation on warfarin: the rate of major hemorrhage and stroke in more than 500 patient-years of follow-up. J Am Geriatr Soc 2005;53:655-9
   PubMed Web of Science ®Google Scholar
• Campbell NR, Hull R, Brant R, Aging and heparin-related bleeding. Arch Intern Med 1996;156:857-60
   PubMed Web of Science ®Google Scholar
• Barras MA, Duffull SB, Atherton JJ, Modelling the occurrence and severity of enoxaparin-induced bleeding and bruising events. Br J Clin Pharmacol 2009;68:700-11
   PubMed Web of Science ®Google Scholar
• Arixtra summary of product characteristics. 2007. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000403/WC500027746.pdf [Last accessed 24 August 2011]
   Google Scholar
• Samama MM, Cohen AT, Darmon JY, A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients. Prophylaxis in Medical Patients with Enoxaparin Study Group. N Engl J Med 1999;341:793-800
   PubMed Web of Science ®Google Scholar
• Alikhan R, Cohen AT, Combe S, MEDENOX Study. Risk factors for venous thromboembolism in hospitalized patients with acute medical illness: analysis of the MEDENOX Study. Arch Intern Med 2004;164:963-8
   PubMed Web of Science ®Google Scholar
• Dahl OE, Kurth AA, Rosencher N, Efficacy and safety profile of dabigatran etexilate for the prevention of venous thromboembolism in moderately renally impaired patients after total knee or hip replacement surgery. Blood (ASH Annual Meeting Abstracts) 2008;112:981
   PubMed Web of Science ®Google Scholar
• Dahl OE, Clemens A, Eriksson BI, 150 mg dabigatran etexilate once daily has a good safety profile and comparable efficacy to enoxaparin for primary prevention of venous thromboembolism after total knee or hip replacement surgery in patients over 75 years of age. Presented at the European Federation of National Associations of Orthopaedics and Traumatology 10th Congress; 3 – 6 June 2009; Vienna, Austria
   Google Scholar
• Dahl OE. Dabigatran etexilate for the prophylaxis of venous thromboembolism after hip or knee replacement: rationale for dose regimen. Clin Appl Thromb Hemost 2009;15(Suppl 1):17S-24S
   Web of Science ®Google Scholar
• Dahl OE, Kurth AA, Rosencher N, Dabigatran etexilate 150 mg once daily for the prevention of venous thromboembolism after total knee or hip replacement surgery in the elderly and those with moderate renal impairment. J Thromb Haemost 2009;7(Suppl 2):695-6
   Google Scholar
• Eriksson I, Dahl OE, Buller HR, 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
   PubMed Web of Science ®Google Scholar
• Fisher WD. Impact of venous thromboembolism on clinical management and therapy after hip and knee arthroplasty. Can J Surg 2011;54:344-51
   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;48:1-22
   PubMed Web of Science ®Google Scholar
• Nutescu EA, Shapiro NL, Chevalier A. New anticoagulant agents: direct thrombin inhibitors. Cardiol Clin 2008;26:169-87
   PubMed Web of Science ®Google Scholar
• Stangier J, Eriksson BI, Dahl OE, Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement. J Clin Pharmacol 2005;45:55-63
   Web of Science ®Google Scholar