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

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Table 4.7: Summary of statistical analyses in apixaban RCTs Trial no. (acronym) ADVANCE 1 Statistical analysis Data management, patient withdrawals Point estimates and 95% CIs for the risk ratio and risk difference between apixaban and enoxaparin were calculated for primary and key secondary outcomes using knee replacement surgery type as stratification factor. Non-inferiority for apixaban on the primary efficacy endpoint would be demonstrated if both of the following conditions were met: Upper bound of the two-sided 95% CI for relative risk
4.2.4 Describe and critique the manufacturer’s approach to outcome selection within each relevant trial. According to NICE scope the outcomes required were: mortality incidence of VTE (symptomatic and asymptomatic) post DVT complications including thrombotic syndrome length of hospital stay joint outcomes (medium and long term), including joint infection adverse effects of treatment including bleeding events health-related quality of life All of the outcomes listed above were reported in the inclusion criteria in Table 4 in MS, page 32-33. Table 4.8 below compares the outcomes identified in the scope with those reported in the relevant trials. Table 4.8: Outcomes mentioned in the NICE scope and reported in relevant trials Trial Mortality Incidence of VTE (symptomatic and asymptomatic) Post DVT complications Pulmonary Embolism Thrombotic syndrome 27 Length of hospital stay Joint outcomes including joint infection AEs of treatment including bleeding events ADVANCE-1 X X X ADVANCE-2 X X X ADVANCE-3 X X X APROPOS X X X X AE=Adverse events Health related quality of life None of the trials reported results for length of hospital stay, joint outcomes, or health related quality of life. Pulmonary embolism was reported by three trials as the main post-DVT complication but results for thrombotic syndrome are not presented in any trial. 4.2.5 To what extent does each relevant trial include the patient population(s), intervention(s), comparator(s) and outcomes as defined in the final scope? Population One trial included patients with total hip replacement (ADVANCE-3), and three trials included patients with total knee replacement (ADVANCE-1 and 2, and APROPOS). Intervention The three ADVANCE trials used the same intervention: oral apixaban, 2.5 mg bd. The APROPOS trial used 6 different doses of apixaban: oral apixaban 5mg, 10mg, 20mg, od and bd. Comparators All apixaban trials directly compare apixaban with enoxaparin, which is included amongst the appropriate comparators stated in the decision problem. ADVANCE-2 and ADVANCE-3 compare Copyright 2011 Queen’s Printer and Controller of HMSO. All rights reserved.
Page 1 and 2: in collaboration with: Apixaban for
Page 3 and 4: Abbreviations AAOS American Academy
Page 5 and 6: 1. SUMMARY ........................
Page 7 and 8: 1. SUMMARY 1.1 Scope of the manufac
Page 9 and 10: The three identified trials, which
Page 11 and 12: Table 2.1. Summary of Annual TKR an
Page 13 and 14: The NICE clinical guideline on redu
Page 15 and 16: Indirect and mixed treatment compar
Page 17 and 18: 4.1.2 State the inclusion/exclusion
Page 19 and 20: APROPOS 2 0 Phase II, randomised, e
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Page 23 and 24: Table 4.5: Results for Apixaban ver
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Page 35 and 36: Table 5.1 Main findings of studies
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Page 41 and 42: Administration of apixaban is oral,
Page 43 and 44: A mixed treatment comparison (MTC)
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Page 51 and 52: Table 5.12 Costs for health states
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Page 71 and 72: References [1] White RH. The epidem
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Appendix 1A: ERG Search Strategies
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76 Comment/ (451657) 77 Letter/ (72
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Appendix 1B: Review of search strat
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Question(s) Appendix 2: Phillips et
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Has the source for all costs been d
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