Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects

References

• 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
   PubMed Web of Science ®Google Scholar
• Fareed J, Hoppensteadt DA, Bick RL. An update on heparins at the beginning of the new millennium. Semin Thromb Hemost 2000;26 (Suppl 1):5-21
   PubMed Web of Science ®Google Scholar
• Hirsh J, Anand SS, Halperin JL,. et al. AHA scientific statement: guide to anticoagulant therapy: heparin: a statement for healthcare professionals from the American Heart Association. Arterioscler Thromb Vasc Biol 2001;21:E9
   PubMedGoogle Scholar
• White RH. The epidemiology of venous thromboembolism. Circulation 2003;107:I4-I8
   PubMed Web of Science ®Google Scholar
• Harrington RA, Becker RC, Ezekowitz M,. et al. Antithrombotic therapy for coronary artery disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126:513S-548S
   PubMed Web of Science ®Google Scholar
• Singer DE, Albers GW, Dalen JE,. et al. Antithrombotic therapy in atrial fibrillation: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126:429S-56S
   PubMed Web of Science ®Google Scholar
• Ansell J, Hirsh J, Dalen J,. et al. Managing oral anticoagulant therapy. Chest 2001;119:22S-38S
   PubMed Web of Science ®Google Scholar
• Hirsh J, Dalen J, Anderson DR,. et al. Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest 2001;119:8S-21S
   PubMed Web of Science ®Google Scholar
• Hirsh J. Current anticoagulant therapy – unmet clinical needs. Thromb Res 2003;109 (Suppl 1):S1-S8
   PubMed Web of Science ®Google Scholar
• Wells PS, Holbrook AM, Crowther NR,. et al. Interactions of warfarin with drugs and food. Ann Intern Med 1994;121:676-83
   PubMed Web of Science ®Google Scholar
• Ansell J, Hirsh J, Poller L,. et al. The pharmacology and management of the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126:204S-33S
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Zuehlsdorf M,. et al. 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
   PubMed Web of Science ®Google Scholar
• Hylek EM. Oral anticoagulants. Pharmacologic issues for use in the elderly. Clin Geriatr Med 2001;17:1-13
   PubMed Web of Science ®Google Scholar
• Mann KG, Butenas S, Brummel K. The dynamics of thrombin formation. Arterioscler Thromb Vasc Biol 2003;23:17-25
   PubMed Web of Science ®Google Scholar
• Biemond BJ, Perzborn E, Friederich PW,. et al. Prevention and treatment of experimental thrombosis in rabbits with rivaroxaban (BAY 59-7939) − an oral, direct Factor Xa inhibitor. Thromb Haemost 2007;97:471-7
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Graff J, von Hentig N, Misselwitz F,. et al. Effects of the oral, direct Factor Xa inhibitor rivaroxaban on platelet-induced thrombin generation and prothrombinase activity. J Clin Pharmacol 2007;47:1398-407
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Fareed J, Hoppensteadt D, Maddenini J,. et al. Antithrombotic mechanism of action of BAY 59-7939 – a novel, oral, direct Factor Xa inhibitor. J Thromb Haemost 2005;3:Abstract P0518
   Google Scholar
• Gerotziafas GT, Elalamy I, Depasse F,. et al. In vitro inhibition of thrombin generation, after tissue factor pathway activation, by the oral, direct Factor Xa inhibitor rivaroxaban. J Thromb Haemost 2007;5:886-8
   PubMed Web of Science ®Google Scholar
• Heeringa J, van der Kuip DAM, Hofman A,. et al. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J 2006;27:949-53
   PubMed Web of Science ®Google Scholar
• Geerts WH, Bergqvist D, Pineo GF,. et al. Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed.). Chest 2008; 133:381-453
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Borris L, Dahl OE,. et al. Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement. J Thromb Haemost 2006;4:121-8
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Perzborn E, Kubitza D, Misselwitz F. Rivaroxaban. A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders. Hämostaseologie 2007;27:282-9
   Google Scholar
• Mueck W, Eriksson B, Borris L,. et al. Rivaroxaban for thromboprophylaxis in patients undergoing total hip replacement: comparison of pharmacokinetics and pharmacodynamics with once- and twice-daily dosing. Blood 2006;108:Abstract 903
   Web of Science ®Google Scholar
• Kubitza D, Becka M, Mueck W,. et al. Pharmacology of the oral, direct Factor Xa inhibitor rivaroxaban – effect of extreme age and gender. Hämostaseologie 2007;27:A40
   Google Scholar
• Eriksson BI, Borris LC, Friedman RJ,. et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. New Engl J Med 2008;358:2765-75
   PubMed Web of Science ®Google Scholar
• Kakkar AK, Brenner B, Dahl OE,. et al. 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,. et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. New Engl J Med 2008;358:2776-86
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Mueck W, Eriksson BI, Bauer KA,. et al. Population pharmacokinetics and pharmacodynamics of rivaroxaban – an oral, direct Factor Xa inhibitor – in patients undergoing major orthopaedic surgery. Clin Pharmacokinet 2008;47:203-16
   PubMed Web of Science ®Google Scholar
• Gross PL, Weitz JI. New anticoagulants for treatment of venous thromboembolism. Arterioscler Thromb Vasc Biol 2008;28:380-6
   PubMed Web of Science ®Google Scholar
• Turpie AG. New oral anticoagulants in atrial fibrillation. Eur Heart J 2008;29:155-65
   PubMed Web of Science ®Google Scholar