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Drug Evaluations

Rivaroxaban, an oral direct factor Xa inhibitor

, MD, , MD, , MD, , MB ChB & , MD
Pages 925-937 | Published online: 21 May 2008

Bibliography

  • Rosamond W, Flegal K, Friday G, et al. Heart disease and stroke statistics – 2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2007;115:e69-171
  • Caprini JA, Botteman MF, Stephens JM, et al. Economic burden of long-term complications of deep vein thrombosis after total hip replacement surgery in the United States. Value Health 2003;6:59-74
  • MacDougall DA, Feliu AL, Boccuzzi SJ, Lin J. Economic burden of deep-vein thrombosis, pulmonary embolism, and post-thrombotic syndrome. Am J Health Syst Pharm 2006;63:S5-15
  • 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;285:2370-5
  • Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham study. Stroke 1991;22:983-8
  • Dulli DA, Stanko H, Levine RL. Atrial fibrillation is associated with severe acute ischemic stroke. Neuroepidemiology 2003;22:118-23
  • Link K. The discovery of dicumarol and its sequels. Circulation 1959;19:97-107
  • Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007;146:857-67
  • The ACTIVE Writing Group on behalf of the ACTIVE Investigators. 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;367:1903-12
  • Jones M, McEwan P, Morgan CL, et al. Evaluation of the pattern of treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non-valvar atrial fibrillation: a record linkage study in a large British population. Heart 2005;91:472-7
  • Hylek EM, Evans-Molina C, Shea C, et al. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007;115:2689-96
  • Breckenridge A, Orme M, Wesseling H, et al. Pharmacokinetics and pharmacodynamics of the enantiomers of warfarin in man. Clin Pharmacol Ther 1974;15:424-30
  • Aithal GP, Day CP, Kesteven PJL, Daly AK. Association of polymorphisms in the cytochrome P450 CYP2C9 with warfarin dose requirement and risk of bleeding complications. Lancet 1999;353:717-9
  • Hirsh J, Dalen JE, Guyatt G. The sixth 2000; ACCP guidelines for antithrombotic therapy for prevention and treatment of thrombosis. Chest 2001;119:S1-2
  • James AH, Britt RP, Raskino CL, Thompson SG. Factors affecting the maintenance dose of warfarin. J Clin Pathol 1992;45:704-6
  • D'Andrea G, D'Ambrosio RL, Di Perna P, et al. A polymorphism in the VKORC1 gene is associated with an interindividual variability in the dose-anticoagulant effect of warfarin. Blood 2005;105:645-9
  • Anderson JL, Horne BD, Stevens SM, et al. Randomized trial of genotype-guided versus standard warfarin dosing in patients initiating oral anticoagulation. Circulation 2007;116:2563-70
  • Gage BF, Birman-Deych E, Radford MJ, et al. Risk of osteoporotic fracture in elderly patients taking warfarin: results from the national registry of atrial fibrillation 2. Arch Intern Med 2006;166:241-6
  • Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation: stroke prevention in atrial fibrillation II study. Lancet 1994;343:687-91
  • Fang MC, Go AS, Hylek EM, et al. Age and the risk of warfarin-associated hemorrhage: the anticoagulation and risk factors in atrial fibrillation study. J Am Geriatr Soc 2006;54:1231-6
  • McCormick D, Gurwitz JH, Goldberg RJ, et al. Prevalence and quality of warfarin use for patients with atrial fibrillation in the long-term care setting. Arch Intern Med 2001;161:2458-63
  • Fang MC, Stafford RS, Ruskin JN, Singer DE. National trends in antiarrhythmic and antithrombotic medication use in atrial fibrillation. Arch Intern Med 2004;164:55-60
  • Olsson SB. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial. Lancet 2003;362:1691-8
  • 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;293:690-8
  • Lee WM, Larrey D, Olsson R, et al. Hepatic findings in long-term clinical trials of ximelagatran. Drug Saf 2005;28:351-70
  • Boos CJ, Lip GYH. Ximelagatran: an eulogy. Thromb Res 2006;118:301-4
  • van Walraven C, Hart RG, Singer DE, et al. Oral anticoagulants vs aspirin in nonvalvular atrial fibrillation: an individual patient meta-analysis. JAMA 2002;288:2441-8
  • Rosenberg RD, Aird WC. Vascular-bed – specific hemostasis and hypercoagulable states. N Engl J Med 1999;340:1555-64
  • Bauer KA. New anticoagulants: anti IIa vs anti Xa – is one better? J Thromb Thrombolysis 2006;21:67-72
  • Mann KG, Brummel K, Butenas S. What is all that thrombin for? J Thromb Haemost 2003;1:1504-14
  • Suzuki K, Dahlback B, Stenflo J. Thrombin-catalyzed activation of human coagulation Factor V. J Biol Chem 1982;257:6556-64
  • Walsh PMD. Platelet coagulation-protein interactions. Semin Thromb Hemost 2004;461-71
  • Kakar P, Watson T, Lip GY. Drug evaluation: rivaroxaban, an oral, direct inhibitor of activated Factor X. Curr Opin Investig Drugs 2007;8:256-65
  • Kubitza D, Haas S. Novel factor Xa inhibitors for prevention and treatment of thromboembolic diseases. Expert Opin Investig Drugs 2006;15:843-55
  • Roehrig S, Straub A, Pohlmann J, et al. Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor. J Med Chem 2005;48:5900-8
  • Biemond BJ, Perzborn E, Friederich PW, et al. Prevention and treatment of experimental thrombosis in rabbits with rivaroxaban (BAY 597939) – an oral, direct Factor Xa inhibitor. Thromb Haemost 2007;97:471-7
  • Perzborn E, Strassburger J, Wilmen A, et al. In vitro and in vivo studies of the novel antithrombotic agent BAY 59-7939 – an oral, direct Factor Xa inhibitor. J Thromb Haemost 2005;3:514-21
  • Kubitza D, Becka M, Mueck W, Zuehlsdorf M. Rivaroxaban (BAY 59-7939) – an oral, direct Factor Xa inhibitor – has no clinically relevant interaction with naproxen. Br J Clin Pharmacol 2007;63:469-76
  • Kubitza D, Becka M, Voith B, et al. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct Factor Xa inhibitor. Clin Pharmacol Ther 2005;78:412-21
  • Mueck W, Becka M, Kubitza D, et al. Population model of the pharmacokinetics and pharmacodynamics of rivaroxaban – an oral, direct Factor xa inhibitor – in healthy subjects. Int J Clin Pharmacol Ther 2007;45:335-44
  • Harder S, Graff J, Hentig NV, et al. Effects of BAY 59-7939, an oral, direct factor Xa inhibitor, on thrombin generation in healthy volunteers. Blood 2003;102(11):3003
  • Kubitza D, Becka M, Wensing G, et al. Safety pharmacodynamics, and pharmacokinetics of BAY-597939 – an oral, direct Factor Xa inhibitor – after multiple dosing in healthy male subjects. Eur J Clin Pharm 2005;61:873-80
  • Kubitza D, Becka M, Wensing G, et al. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939 – an oral, direct Factor Xa inhibitor – after multiple dosing in healthy male subjects. Eur J Clin Pharmacol 2005;61:873-80
  • Halabi A, Maatouk H, Klause N, et al. Effects of renal impairment on the pharmacology of rivaroxaban (BAY 59-7939) – an oral, direct, Factor Xa inhibitor. ASH Annual Meeting Abstracts. 2006;108:913
  • Kubitza D, Becka M, Zuehlsdorf M, Mueck W. Body weight has limited influence on the safety, tolerability, pharmacokinetics, or pharmacodynamics of rivaroxaban (BAY 59-7939) in healthy subjects. J Clin Pharmacol 2007;47:218-26
  • Kubitza D, Becka M, Zuehlsdorf M, Mueck W. Effect of food, an antacid, and the H2 antagonist ranitidine on the absorption of BAY 59-7939 (rivaroxaban), an oral, direct Factor Xa inhibitor, in healthy subjects. J Clin Pharmacol 2006;46:549-58
  • Kubitza D, Becka M, Mueck W, Zuehlsdorf M. Safety, tolerability, pharmacodynamics, and pharmacokinetics of rivaroxaban – an oral, direct Factor Xa inhibitor – are not affected by aspirin. J Clin Pharmacol 2006;46:981-90
  • Kubitza D, Becka M, Zuelsdorf M, Mueck W. No interaction between the novel, oral direct Factor XA inhibitor BAY 59-7939 and digoxin. J Clin Pharmacol 2006;46:11
  • Kubitza D, Becka M, Voith B, Zuehlsdorf M. Effect of enoxaparin on the safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 59-7939 – an oral, direct factor Xa inhibitor. J Thromb Haemost 2005;3:1704
  • Tinel H, Huetter J, Perzborn E. Partial reversal of the anticoagulant effect of high-dose rivaroxaban – an oral, direct Factor Xa inhibitor – by recombinant factor VIIa in rats. Blood 2006;108:915
  • Fisher WD, Eriksson BI, Bauer KA, et al. Rivaroxaban for thromboprophylaxis after orthopaedic surgery: pooled analysis of two studies. Thromb Haemost 2007;97:931-7
  • Kubitza D, Mueck W, Becka M. Randomized, double-blind, crossover study to investigate the effect of rivaroxaban on QT-interval prolongation. Drug Saf 2008;31:67-77
  • Agnelli G, Gallus A, Goldhaber SZ, et al. Treatment of proximal deep-vein thrombosis with the oral direct Factor Xa inhibitor rivaroxaban (BAY 59-7939): the ODIXa-DVT (oral direct factor Xa inhibitor BAY 59-7939 in patients with acute symptomatic deep-vein thrombosis) study. Circulation 2007;116:180-7
  • Eriksson BI, Borris LC, Dahl OE, et al. Dose-escalation study of rivaroxaban (BAY 59-7939) – an oral, direct Factor Xa inhibitor – for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Res 2007
  • Eriksson BI, Borris LC, Dahl OE, et al. Dose-escalation study of rivaroxaban (BAY 59-7939) – an oral, direct Factor Xa inhibitor – for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Res 2007;120:685-93
  • Turpie AG, Fisher WD, Bauer KA, et al. BAY 59-7939: an oral, direct Factor Xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement. A phase II dose-ranging study. J Thromb Haemost 2005;3:2479-86
  • Fisher WD, Eriksson BI, Bauer KA, et al. Rivaroxaban for thromboprophylaxis after orthopaedic surgery: pooled analysis of two studies. Thromb Haemost 2007;97(6):931-7
  • Eriksson BI, Borris LC, Dahl OE, et al. A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement. Circulation114:2374-81
  • Lassen M, Turpie AG, Rosencher N, et al. Rivaroxaban: an oral, direct Factor Xa inhibitor for the prevention of venous thromboembolism in total knee replacement surgery – results of the RECORD3 study. XXIst Congress of the International Society on Thrombosis and Haemostasis; Geneva, Switzerland; 2007
  • Eriksson BI, Borris LC, Dahl OE, et al. A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement. Circulation 2006;114:2374-81
  • Lassen M, Turpie AG, Rosencher N, et al. Rivaroxaban: an oral, direct Factor Xa inhibitor for the prevention of venous thromboembolism in total knee replacement surgery – results of the RECORD3 study. XXIst Congress of the International Society on Thrombosis and Haemostasis; Geneva, Switzerland; 8 July 2007
  • Eriksson BI, Borris LC, Friedman RJ, et al. Oral rivaroxaban compared with subcutaneous enoxaparin for extended prophylaxis after total hip arthroplasty: the RECORD 1 trial. Blood 2007;110:6
  • Kakkar AK, Brenner B, Dahl OE, et al. Extended thromboprophylaxis with rivaroxaban compared with short-term thromboprophylaxis with enoxaparin after total hip arthroplasty: the RECORD 2 trial. Blood 2007;110:307
  • Büller H, Agnelli G. Once- or twice-daily rivaroxaban for the treatment of proximal deep vein thrombosis: similar efficacy and safety to standard therapy in dose-ranging studies. Blood 2006;108:572
  • Rivaroxaban in combination with aspirin alone or with aspirin and a thienopyridine in subjects with acute coronary syndromes (The ATLAS ACS TIMI 46 trial). Identifier NCT00402597. Available from: www.clinicaltrials.gov [Last accessed 5 April 2008]
  • Connolly SJ, Eikelboom J, O'Donnell M, et al. Challenges of establishing new antithrombotic therapies in atrial fibrillation. Circulation 2007;116:449-55
  • Kaul S, Diamond GA, Weintraub WS. Trials and tribulations of non-inferiority: the ximelagatran experience. J Am Coll Cardiol 2005;46:1986-95
  • Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001;23:1296-310
  • Richter A, Anton SE, Koch P, Dennett SL. The impact of reducing dose frequency on health outcomes. Clin Ther 2003;25:2307-35
  • Jacobson BC, Ferris TG, Shea TL, et al. Who is using chronic acid suppression therapy and why? Am J Gastroenterol 2003;98:51-8
  • Agnelli G, Haas S, Ginsberg JS, et al. A phase II study of the oral Factor Xa inhibitor LY517717 for the prevention of venous thromboembolism after hip or knee replacement. J Thromb Haemost 2007;5:746-53
  • 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
  • Eriksson BI, Dahl OE, Rosencher N, et al. 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
  • Eriksson BI, Dahl OE, Rosencher N, et al. 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
  • Turpie AGG. Oral, direct Factor Xa inhibitors in development for the prevention and treatment of thromboembolic diseases. Arterioscler Thromb Vasc Biol 2007;27:1238-47

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