Apixaban for the prevention of venous thromboembolism in people ...

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[12] Appendix 4: Searching for adverse effects [Internet]. In: Centre for Reviews and Dissemination. Systematic Reviews: CRD’s guidance for undertaking reviews in health care. York: University of York, 2009 [cited 27.04.11]. 253-254p. Available from: http://www.york.ac.uk/inst/crd/SysRev/- !SSL!/WebHelp/SysRev3.htm [13] Kleijnen Systematic Reviews (KSR) Ltd. Apixaban for prevention VTE after elective THR and TKR – request for clarification from the manufacturer. York: KSR Ltd., 2011: 3p. [14] Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med 2009;361(6):594-604. [15] Bristol-Myers Squibb Pharmaceuticals Ltd., Pfizer Ltd. Clinical study report for study CV185034 (ADVANCE 1). A phase 3 randomised, double-blind, active-controlled (enoxaparin), parallelgroup, multi-centre study to evaluate the safety and efficacy of oral apixaban in subjects undergoing elective total knee replacement surgery. [Data on file], 2009 [16] Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet 2010;375(9717):807-15. [17] Bristol-Myers Squibb Pharmaceuticals Ltd., Pfizer Ltd. Clinical study report for study CV185047 (ADVANCE 2). A phase 3, randomised, double-blind, active-controlled (enoxaparin 40 mg QD), parallel group, multi-centre study to evaluate the safety and efficacy of apixaban in subjects undergoing elective total knee replacement surgery. [Data on file], 2009 [18] Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med 2010;363(26):2487-98. [19] Bristol-Myers Squibb Pharmaceuticals Ltd., Pfizer Ltd. Clinical Study Report for Study CV185035. A phase 3, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of apixaban in subjects undergoing elective total hip replacement surgery (The Advance-3 Study Apixaban Dosed Orally Versus AntiCoagulation with Injectable Enoxaparin to prevent venous thromboembolism) [Data on file], 2009 [20] Lassen MR, Davidson BL, Gallus A, Pineo G, Ansell J, Deitchman D. The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement. J Thromb Haemost 2007;5(12):2368-75. [21] Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, 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(9591):949-56. [22] Eriksson BI, Dahl OE, Huo MH, Kurth AA, Hantel S, Hermansson K, et al. 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(4):721-9. 72 Copyright 2011 Queen’s Printer and Controller of HMSO. All rights reserved.
[23] Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, 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(11):2178-85. [24] Ginsberg JS, Davidson BL, Comp PC, Francis CW, Friedman RJ, Huo MH, et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty 2009;24(1):1-9. [25] Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008;358(26):2765-75. [26] Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, 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(9632):31-9. [27] Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008;358(26):2776-86. [28] Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009;373(9676):1673-80. [29] Lassen MR, Bauer KA, Eriksson BI, Turpie AGG. Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: a randomised double-blind comparison. Lancet 2002;359(9319):1715-20. [30] Turpie AGG, Bauer KA, Eriksson BI, Lassen MR. Postoperative fondaparinux versus postoperative enoxaparin for prevention of venous thromboembolism after elective hipreplacement surgery: A randomised double-blind trial. Lancet 2002;359(9319):1721-26. [31] Bauer KA, Eriksson BI, Lassen MR, Turpie AGG. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery. N Engl J Med 2001;345(18):1305-10. [32] Huo M, Eriksson BI, Dahl OE, Kurth AA, Hantel S, Hermansson K, et al. Oral dabigatran versus enoxaparin fro thromboprophylaxis after primary total hip arthroplasty: The RENOVATE-II randomised trial (abstract). European Hematology Association; 2010 October 22-24; . Beirut, Lebanon, 2010. [33] European Medicines Agency, Committee for Propriety Medicinal Products (CPMP). Points to consider on clinical investigation of medicinal products for prophylaxis of intra- and postoperative venous thromboembolic risk [Internet], 2000 [cited 31.8.11]. Report No: CPMP/EWP/707/98 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/- Scientific_guideline/2009/09/WC500003304.pdf 73 Copyright 2011 Queen’s Printer and Controller of HMSO. All rights reserved.
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in collaboration with: Apixaban for
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Abbreviations AAOS American Academy
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1. SUMMARY ........................
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1. SUMMARY 1.1 Scope of the manufac
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The three identified trials, which
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Table 2.1. Summary of Annual TKR an
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The NICE clinical guideline on redu
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Indirect and mixed treatment compar
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4.1.2 State the inclusion/exclusion
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APROPOS 2 0 Phase II, randomised, e
Page 21 and 22: 4.2 Summary and critique of submitt
Page 23 and 24: Table 4.5: Results for Apixaban ver
Page 25 and 26: Trial no. (acronym) ADVANCE 1 ADVAN
Page 27 and 28: 4.2.4 Describe and critique the man
Page 29 and 30: Table 4.9: Results from indirect co
Page 31 and 32: Results for the main outcomes from
Page 33 and 34: 5 COST EFFECTIVENESS 5.1 ERG commen
Page 35 and 36: Table 5.1 Main findings of studies
Page 37 and 38: 5.2.2 Model structure The manufactu
Page 39 and 40: died in the decision tree enter the
Page 41 and 42: Administration of apixaban is oral,
Page 43 and 44: A mixed treatment comparison (MTC)
Page 45 and 46: Long term recurrent risks of VTE an
Page 47 and 48: 5.2.7 Health related quality of lif
Page 49 and 50: on assumptions, and not further jus
Page 51 and 52: Table 5.12 Costs for health states
Page 53 and 54: Table 5.14 Drug and administration
Page 55 and 56: Comment - The ERG restructured the
Page 57 and 58: 5.2.10 Sensitivity analyses Methods
Page 59 and 60: Figure 5.3 Cost-effectiveness accep
Page 61 and 62: Figure 5.6 Cost-effectiveness accep
Page 63 and 64: Cost-Effectiveness Acceptability Cu
Page 65 and 66: Cost-Effectiveness Acceptability Cu
Page 67 and 68: number of QALYs gained by dabigatra
Page 69 and 70: 5.4 Conclusions Describe the comple
Page 71: References [1] White RH. The epidem
Page 75 and 76: ISPOR 11th Annual European Congress
Page 77 and 78: Appendix 1A: ERG Search Strategies
Page 79 and 80: 85 84 not 83 (88613) 86 1 or 2 or 3
Page 81 and 82: 76 Comment/ (451657) 77 Letter/ (72
Page 83 and 84: 68 Motion Therapy, Continuous Passi
Page 85 and 86: 23 pentasaccharide*.mp. (2192) 24 e
Page 87 and 88: Appendix 1B: Review of search strat
Page 89 and 90: Question(s) Appendix 2: Phillips et
Page 91 and 92: Has the source for all costs been d
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