Review of Non-VKA Oral AntiCoagulants (NOACs) and their use in Great Britain

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1 Review of Non-VKA Oral AntiCoagulants (NOACs) and their use in Great Britain Dr Alexander (Ander) Cohen Guy s and St Thomas Hospitals, King s College London, UK Pavia Spring Meeting 13 June 2014

2 Overview Atrial fibrillation VTE treatment Limitations

3

4 Lessons from Clinical Trials in Atrial Fibrillation All of the novel oral anticoagulants are at least as effective as warfarin and can be given without routine monitoring All agents reduce the risk of intracranial bleeding Novel agents produce about a 10% reduction in mortality

5 Novel Oral Anticoagulants vs. Warfarin: Stroke or Systemic Embolism Superiority p-value Dabigatran 110 mg BID Dabigatran 150 mg BID Rivaroxaban 20 mg QD Apixaban 5 mg BID Edoxaban 30 mg Edoxaban 60 mg 0.29 < HR (95% CI) Warfarin better Comparator better Connolly SJ, et al. NEJM 2009; Alexander J, et al. NEJM 2011; Mahaffey K, et al. NEJM 2011; Giugliano RP, et al. NEJM 2013

6 Novel Oral Anticoagulants vs. Warfarin: Ischemic Stroke Superiority p-value Dabigatran 110 mg BID Dabigatran 150 mg BID Rivaroxaban 20 mg QD Apixaban 5 mg BID Edoxaban 30 mg Edoxaban 60 mg < HR (95% CI) Comparator better Warfarin better Connolly SJ, et al. NEJM 2009; Alexander J, et al. NEJM 2011; Mahaffey K, et al. NEJM 2011; Giugliano RP, et al. NEJM 2013

7 Novel Oral Anticoagulants vs. Warfarin: All-Cause Mortality Superiority p-value Dabigatran 110 mg BID Dabigatran 150 mg BID Rivaroxaban 20 mg QD Apixaban 5 mg BID Edoxaban 30 mg Edoxaban 60 mg HR (95% CI) Comparator better Warfarin better Connolly SJ, et al. NEJM 2009; Alexander J, et al. NEJM 2011; Mahaffey K, et al. NEJM 2011; Giugliano RP, et al. NEJM 2013

8 Novel Oral Anticoagulants vs. Warfarin: Intracranial Hemorrhage Superiority p-value Dabigatran 110 mg BID Dabigatran 150 mg BID Rivaroxaban 20 mg QD Apixaban 5 mg BID Edoxaban 30 mg Edoxaban 60 mg <0.001 < <0.001 <0.001 < HR (95% CI) Comparator better Warfarin better Connolly SJ, et al. NEJM 2009; Alexander J, et al. NEJM 2011; Mahaffey K, et al. NEJM 2011; Giugliano RP, et al. NEJM 2013

9 Novel Oral Anticoagulants vs. Warfarin: ISTH Major Bleeding Dabigatran 110 mg BID Dabigatran 150 mg BID Rivaroxaban 20 mg QD Apixaban 5 mg BID Edoxaban 30 mg Edoxaban 60 mg Superiority p-value <0.001 <0.001 < HR (95% CI) Warfarin better Comparator better Connolly SJ, et al. NEJM 2009; Alexander J, et al. NEJM 2011; Mahaffey K, et al. NEJM 2011; Giugliano RP, et al. NEJM 2013

10 Differentiators Dabigatran, at a dose of 150 mg, reduces ischemic stroke Apixaban and edoxaban reduce hemorrhagic stroke and major bleeding Rivaroxaban is associated with a lower rate of fatal bleeding but an increase rate of GI bleeding

11 Network comparisons Not direct comparisons nor head to head comparisons Use a common comparator as the anchoring point E.g. Warfarin or Standard of Care Network plotting Network Meta-Analyses (NMA) Used widely in HTA (Health Technology Assessments) (aka Horse Trading Association)

12 Network plotting indirect comparisons Comparing efficacy and safety on opposing axes Efficacy on X axis Safety on Y axis Give you a feel for the data Best results are in the bottom left of page (opposite to marketing strategy)

13 Trade off Safety - HR of major bleed Worst Efficacy - HR stroke & SE Best Trade off

14 NOACs vs. warfarin for stroke prevention in NVAF Primary efficacy and Major Bleeding HR major bleed Hazard ratios (or for dabigatran risk reductions) and 95% confidence intervals in comparison with warfarin Trade off Worst These are not head-tohead comparisons between the NOACs R HR stroke & SE D150 D A 0.6 Best 0.5 Trade off Adapted from S. Schulman / Thrombosis Research 131, Suppl. 1 (2013) S63 S66.

15 NOACs for Stroke Prevention in AF At least as effective as warfarin, but safer for the brain More convenient to administer, which may increase uptake of anticoagulant prophylaxis in eligible AF patients

16 VTE Treatment

17 Recurrent VTE and VTE-related Death Dabigatran Rivaroxaban Apixaban P-value (non-inferiority) <0.001 <0.001 <0.001 Edoxaban < Favors NOAC Favors Warfarin HR (95% CI) Schulman S, et al. N Engl J Med 2009; Agnelli G, et al. N Engl J Med, 2013; Prins M, et al. Thromb J, 2013; Hokusai VTE, N Engl J Med, 2013

18 Major Bleeding Dabigatran Rivaroxaban Apixaban Edoxaban P-value (superiority) NS <0.002 <0.001 NS Major and CRNB Dabigatran Rivaroxaban Apixaban Edoxaban 0.25 Favors NOAC HR (95% CI) 1.50 < < Favors Warfarin Schulman S, et al. Circulation 2013; Agnelli G, et al. N Engl J Med, 2013; Prins M, et al. Thromb J, 2013; Hokusai VTE, N Engl J Med, 2013

19 VTE recurrence (HR [95% CI]) Efficacy and Safety of NOACs vs Comparator in Acute VTE Not head to head comparisons: these comparisons have not been made in a head to head study 2 More recurrences, fewer bleeds to 2.64 More recurrences, more bleeds RE-MEDY N=2856 RE-COVER 1 N=2564 RE-COVER 2 N=2568 EINSTEIN-PE N= AMPLIFY N=5400 Hokusai-VTE N= Fewer recurrences, fewer bleeds Cohen A T et al., Adv Ther 2014 May 13. [Epub ahead of print; DOI /s ]. EINSTEIN-DVT N=3449 Fewer recurrences, more bleeds 1 2 Major or CRNM bleeding (HR [95% CI]) EUAPI589

20 VTE recurrence (HR [95% CI]) Efficacy and Safety of NOACs vs Placebo in Extended VTE Not head to head comparisons: these comparisons have not been made in a head to head study More recurrences, fewer bleeds 1 More recurrences, more bleeds Fewer recurrences, fewer bleeds Fewer recurrences, more bleeds 0.2 AMPLIFY-Ext* Apixaban 2.5 mg N=1669 AMPLIFY-Ext* Apixaban 5 mg N=1642 EINSTEIN-Ext* N=1197 to RE-SONATE* N= Cohen AT et al., Adv Ther 2014 May 13. [Epub ahead of print; DOI /s ] Major or CRNM bleeding (HR [95% CI]) EUAPI589

21 NOACs for VTE Treatment As effective as conventional therapy Associated with less bleeding

22 What Do We Still Need to Know? Utility for VTE treatment in the setting of cancer Can the dose be lowered for long-term secondary prevention (AMPLIFY-EXT)?

23 NOACs in Patients with Active Cancer Few patients studied (total of 962) Comparator was warfarin and not LMWH

24 Which VTE Patients are not Candidates for Novel Anticoagulants? Severe PE or extensive DVT Stable on warfarin Severe renal or hepatic insufficiency High initial risk of bleeding

25

26 Deep Vein Thrombosis

27 Pulmonary Emboli

28 Pulmonary embolus

29 Which VTE Patients are not Candidates for Novel Anticoagulants? Severe PE or extensive DVT Stable on warfarin Severe renal or hepatic insufficiency High initial risk of bleeding

30 NOACs for VTE Treatment Novel oral anticoagulants streamline treatment Need more information on their utility in patients with cancer and optimal dosing for extended therapy

31 Limitations of NOACs No specific antidotes Assessment of anticoagulant activity is complicated Adherence difficult to assess

32 Use of NOACS in the UK

33 Times are changing

34 Use of NOACS in the UK Prefer VTE Registry ICT Seville May 2014

35 Conclusions NOACs represent an important advance in oral anticoagulation Patient selection is critical

36 Say nothing more

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