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Safety and efficacy of rivaroxaban for thromboprophylaxis following lower limb surgery: an update

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Pages 687-696 | Published online: 15 Mar 2011

Bibliography

  • Callaghan JJ, Dorr LD, Engh GA, Prophylaxis for thromboembolic disease: recommendations from the American College of Chest Physicians–are they appropriate for orthopaedic surgery? J Arthroplasty 2005;20(3):273-4
  • House of Commons Health Committee Report. The prevention of venous thromboembolism in hospitalised Patients 2010. Available from: http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/99/99.pdf
  • Venous thromboembolism – reducing the risk in surgical inpatients. National Institute of Health and Clinical Excellence (NICE) Guideline, April 2007. Available from: http://www.nice.org.uk/CG46
  • Pellegrini VD, Donaldson CT, Farber DC, Prevention of readmission for venous thromboembolic disease after total hip arthroplasty. Clin Orthop 2005;441:56-62
  • Geerts WH, Pineo GF, Heit JA, Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126:338S-400S
  • Sharif KM, Rehman SF, Nunn T, Implementation of the NICE guidelines for venous thromboprophylaxis; a national survey of hip surgeons. Hip International 2009;19:58-63
  • Furie B, Furie BC. Molecular basis of vitamin K-dependent c-carboxylation. Blood 1990;75:1753-62
  • Weitz JI, Hirsh J, Samama MM. New antithrombotic drug. American College of Chest Physicians evidence-based clinical practice guidelines, 8th edition. Chest 2008;133:234S-256S
  • Clexane (enoxaparin). Summary of Product Characteristics. Available from: http://emc.medicines.org.uk/document.aspx?documentId=12847
  • Brown GA. Venous thromboembolism prophylaxis after major orthopaedic surgery: a pooled analysis of randomized controlled trials. J Arthroplasty 2009;24(Suppl 6):77-83
  • Venous thromboembolism – reducing the risk. National Institute of Health and Clinical Excellence (NICE) Guideline, January 2010. Available from: http://www.nice.org.uk/CG92
  • Turpie AG, Bauer KA, Eriksson BI, Superiority of fondaparinux over enoxaparin in preventing venous thromboembolism in major orthopaedic surgery using different efficacy end points. Chest 2004;126:501-8
  • Costing statement: Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults. Available from: http://www.nice.org.uk/nicemedia/pdf/TA157CostStatement.PDF
  • Gross PL, Weitz JI. New anticoagulants for treatment of venous thromboembolism. Arterioscler Thromb Vasc Biol 2008;28:380-6
  • Kubitza D, Becka M, Voith B, Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939 – an oral, direct Factor Xa inhibitor. Clin Pharmacol Ther 2005;78:412-21
  • Kubitza D, Becka M, Wensing G, 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
  • Kubitza D, Becka M, Mueck W, Zuehlsdorf M. The effect of extreme age, and gender, on pharmacology and tolerability of rivaroxaban – an oral, direct Factor Xa inhibitor. Blood 2006;108: abstract 905
  • Kubitza D, Becka M, Roth A, Mueck W. Dose escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects. Curr Med Res Opinion 2008;24:2757-65
  • Kubitza D, becka M, Zuehlsdorf M, Mueck W. Body weight has limited influence of safety, tolerability, pharmacokinetics, or pharmacodynamics of rivaroxaban (BAY 59-7939) in healthy subjects. J Clin Pharmacol 2007;47:218-26
  • Weinz C, Radtke M, Schmeer K, In vitro metabolism of BAY 59-7939 – an oral, direct Factor Xa inhibitor. Drug Metab Rev 2004;36(Suppl 1): abstract 195
  • Weinz C, Schwartz T, Pleiss U, Metabolism and distribution of BAY 59-7939 – an oral, direct Factor Xa inhibitor – in rat, dog, and human. Drug Metab Rev 2004;36: abstract 196
  • Xarelto® Summary of product characteristics. Available from: http://www.xarelto.com/html/downloads/xarelto_summary_of_product_characteristics_30sept2008.pdf
  • Bauer K, Homering M, Berkowitz S. Effects of Age, Weight, Gender and Renal Function in a Pooled Analysis of Four Phase III Studies of Rivaroxaban for Prevention of Venous Thromboembolism after Major Orthopaedic Surgery. Blood (ASH Annual Meeting Abstracts) 2008;112:436
  • Halabi A, Kubitza D, Zuehlsdorf M, Effect of hepatic impairment on the pharmacokinetics, pharmacodynamics and tolerability of rivaroxaban – an oral, direct Factor Xa inhibitor. J Thromb Haemost 2007;5(Suppl 2): abstract P-M-635
  • 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 Factor Xa inhibitor, in healthy subjects. J Clin Pharmacol 2006;46:549-58
  • Kubitza D, Becka M, Mueck W, Zuehlsdorf M. Rivaroxaban (BAY 59-7939) - an oral Factor Xa inhibitor – has no clinically relevant interaction with naproxen. Br J Clin Pharmacol 2007;63:469-79
  • Kubitza D, Becka M, Mueck W, Zuehlsdorf M. Safety, tolerability, pharmacodynamics, and pharmacokinetics of rivaroxaban - an oral Factor Xa inhibitor – are not affected by aspirin. J Clin Pharmacol 2006;46:981-90
  • Kubitza D, Becka M, Mueck W, Zuehlsdorf M. Co-administration of rivaroxaban – a novel, oral, direct Factor Xa inhibitor – and clopidogrel in healthy subjects. Eur Heart J 2007;28(Suppl 1):189
  • Perzborn E, Harwardt M. Recombinant factor VIIa partially reverses the effects of the factor Xa inhibitor rivaroxaban on thrombin generation, but not the effects of thrombin inhibitors, in vitro. J Thromb Haemost 2007;5: abstract PW640
  • Eriksson BI, Borris LC, Dahl OE, A once-daily, oral, factor Xa inhibitor, rivaroxaban (BAY59-7939), for thromboprophylaxis after total hip replacement. Circulation 2006;114:2374-81
  • Eriksson BI, Borris LC, Dahl OE, Oral, direct factor Xa inhibition with BAT 59-7939 for the prevention of venous thromboembolism after total hip replacement. J Thromb Haemost 2006;4:121-8
  • Eriksson BI, Borris LC, Dahl OE, 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, 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
  • Eriksson BI, Borris LC, Friedman RJ, Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008;358(26):2765-75
  • 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
  • Lassen MR, Ageno W, Borris LC, Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Eng J Med 2008;358:2776-86
  • Turpie AG, Lassen MR, Davidson BL, Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009;373:1673-80
  • Eriksson BI, Kakkar AK, Turpie AG, Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement. J Bone Joint Surg Br 2009;91:636-44
  • Huo M. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty: the RE-NOVATE II randomized trial. Presented at: 15th Congress of the European Hematology Association; 10 – 13 June; Barcelona
  • 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
  • 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
  • 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
  • Wolowacz SE, Roskell NS, Plumb JM, Efficacy and safety of dabigatran etexilate for the prevention of venous thromboembolism following total hip or knee arthroplasty. A meta-analysis. Thromb Haemost 2009;101:77-85
  • Hull RD, Liang J. Pooled analysis of trials may, in the presence of heterogeneity inadvertently lead to fragile conclusions due to the importance of clinically relevant variables being either hidden or lost when the findings are pooled. Thromb Res 2010;126:164-5
  • Trkulja V, Kolundzic R. Rivaroxaban vs dabigatran for thromboprophylaxis after joint-replacement surgery: exploratory indirect comparison based on meta-analysis of pivotal clinical trials. Croat Med J 2010;51(2):113-23
  • Grosso A. Drug appraisal: Dabigatran vs rivaroxaban for thromboprophylaxis. Br J Clin Pharm Vol.1 September 2009. Available from: (http://www.clinicalpharmacy.org.uk/September/drugappraisal.pdf)
  • Diamantopoulos A, LeReun C, Rasul F, Indirect Comparisons of Rivaroxaban Versus Alternative Prophylaxes for the Prevention of VTE in Patients Undergoing Total Knee Replacement. ASH Annual Meeting Abstracts. Blood 2008;112: abstract 1292
  • Search of Clinicaltrials.gov for rivaroxaban (10/10/2010). Available from: http://clinicaltrials.gov/ct2/results?term=rivaroxaban
  • MAGELLAN - Multicenter, rAndomized, Parallel Group Efficacy and Safety for the Prevention of VTE in Hospitalized Medically iLL Patients Comparing rivaroxabAN With Enoxaparin. Available from: http://clinicaltrials.gov/ct2/show/NCT00571649 [Last accessed 17th January 2010]
  • Oral direct factor xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis without symptomatic pulmonary embolism: Einstein-DVT evaluation. Available from: http://clinicaltrials.gov/ct2/show/NCT00440193 [Last accessed 17th January 2010]
  • Once - daily oral direct factor xa inhibitor rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension Study. Available from: http://clinicaltrials.gov/ct2/show/NCT00439725 [Last accessed 17th January 2010]
  • Oral direct factor xa inhibitor rivaroxaban in patients with acute symptomatic pulmonary embolism with or without symptomatic deep-vein thrombosis: Einstein-PE Evaluation. Available from: http://clinicaltrials.gov/ct2/show/NCT00439777 [Last accessed 17th January 2010]
  • A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation. Available from: http://clinicaltrials.gov/ct2/show/NCT00403767 [Last accessed 17th January 2010]
  • A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome. Available from: http://clinicaltrials.gov/ct2/show/NCT00809965 [Last accessed 17th January 2010]
  • Bauersachs R, Berkowitz SD, Brenner B, ; Einstein Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363(26):2499-510
  • ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J 2010;159(3):340-7
  • Connolly SJ, Ezekowitz MD, Yusuf S, Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51
  • Roberts CS, Gleis GE, Seligson D. Diagnosis and treatment of complications. In: Browner BD, Jupiter JB, Levine AM, Trafton PG, Krettek C. editors, Skeletal trauma. 4th edition. W. B. Saunders Co., Philadelphia; 2009. p. 545-88
  • Velmahos GC. The current status of thromboprophylaxis after trauma: a story of confusion and uncertainty. Am Surg 2006;72:757-63
  • Slobogean GP, Kelly LA, Nicolaou S, A systematic review of thromboprophylaxis for pelvic and acetabular fractures. J Orthop Trauma 2009;23:379-84
  • Latronico N, Berardino M. Thromboembolic prophylaxis in head trauma and multiple-trauma patients. Minerva Anestesiol 2008;74:543-8
  • Lassen MR, Borris LC, Nakov RL. Use of low-molecular weight heparin reviparin to prevent deep-vein thrombosis after leg injury requiring immobilization. N Eng J Med 2002;347(10):726-30
  • Sems SA, Bruce LA, Khaled D, Incidence of deep venous thrombosis after temporary joint spanning external fixation for complex lower extremity injuries. J Trauma 2009;66:1164-6
  • Parker M, Johansen A. Hip fracture. BMJ 2006;333(7557):27-30
  • NICE costing statement: rivaroxaban for the prevention of VTE after TKR and THR in adults- Available from: http://www.nice.org.uk/nicemedia/live/12133/43807/43807.pdf
  • McCullagh L, Tilson L, Walsh C, A Cost-effectiveness model comparing rivaroxaban and dabigatran etexilate with enoxaparin sodium as thromboprophylaxis after total hip and total knee replacement in the irish Healthcare Setting. Pharmacoeconomics 2009;27:829-46

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