Financial Disclosures

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1 Financial Disclosures Consulting: AstraZeneca, Bayer, Boehringer Ingleheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Glaxo Smith Kline, Johnson & Johnson, Merck, Novartis, Ortho/McNeill, Pfizer, Polymedix, Sanofi-Aventis, Schering-Plough Grant Support: AstraZeneca, Bayer, Boehringer Ingleheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Glaxo Smith Kline, Johnson & Johnson, Merck, Momenta Pharmaceuticals, Novartis, Portola, Pozen, Regado Biotechnologies, Sanofi- Aventis, Schering-Plough, The Medicines Company Full disclosures available on

2 New Oral Anticoagulants Should Be Standard of Care Versus Warfarin in Atrial Fibrillation Kenneth W. Mahaffey, MD Co-Director, CV Research Director, CEC Group Duke Clinical Research Institute Durham, NC

3 AF-Related Stroke Greater disability compared to non-af related stroke¹ higher mortality (AF vs no AF = 1.84)¹ larger infarcts (52 vs. 16 ml, p=0.05)² more severe hemorrhagic transformation (29 vs. 5%, p=0.002 for parenchymal hematomas)² 2.3 million with AF in N. America - $3600 per patient per year 3 Severe disability (% of stroke patients) AF 11 Acute 3 m 6 m 12 m Time a'er stroke event AF (n) Non-AF (n) Non-AF 1. Lin HJ, et al. Stroke 1996 Oct;27(10): Tu HT, et al. Cerebrovasc Dis 2010;30(4): Le Heuzey JY, Am Heart J 2004

4 ACC/AHA/ESC 2006 Guidelines and ACCF/AHA/HRS 2011 Focused Update Risk category No risk factors One moderate risk factor Any high risk factor or more than 1 moderate risk factor Recommended prophylaxis Aspirin mg daily Aspirin mg daily, or warfarin, alterna?ve dabigatran (NVAF) Warfarin, alterna?ve dabigatran (NVAF) Less validated/weaker risk factors Moderate risk factors High risk factors Female gender Age 75 years Previous stroke, TIA or embolism Age 65 to 74 years Hypertension Mitral stenosis Coronary artery disease Heart failure ProstheQc heart valve Thyrotoxicosis LVEF 35% Diabetes mellitus NVAF = non valvular atrial fibrillaqon Wann LS, et al. J Am Coll Cardiol Mar 15;57(11): Wann LS, et al. CirculaQon Mar 15;123(10): Fuster V, et al. CirculaQon Aug 15;114(7):e

5 Warfarin Battling All Comers for Decades Warfarin vs placebo Warfarin vs ASA Warfarin vs ASA + fixed dose Warfarin vs dual antiplatelet Warfarin vs DTI Warfarin vs Factor Xa

6 Old Era of Anticoagulation for Afib

7 New Era of Anticoagulation for Afib 5 Trials 3 Drugs Dabigatran Apixaban Rivaroxaban > 55,000 patients Global exposure Pragmatic studies Strong foundation for evidence-based clinical decisions

8 Drug and Trial Comparisons Cross trial comparisons are common but often misleading ROCKET, RELY, and ARISTOTLE: Different drugs Different trial designs Different patient populations The best method to compare drugs is headto-head, randomized comparisons in large populations

9 New Anticoagulants vs Wafarin Stroke or Systemic Embolism Dabigatran 150 mg b.i.d. Dabigatran 110 mg b.i.d. Rivaroxaban 20 mg o.d. Abixaban 5 mg b.i.d New Anticoagulant Warfarin Better Better Connolly S et al NEJM 2009; Patel M et al NEJM 2011; Granger C et al NEJM 2011

10 New Anticoagulants vs Wafarin Intracranial Hemorrhage Dabigatran 150 mg b.i.d. Dabigatran 110 mg b.i.d. Rivaroxaban 20 mg o.d. Abixaban 5 mg b.i.d New Anticoagulant Warfarin Better Better Connolly S et al NEJM 2009; Patel M et al NEJM 2011; Granger C et al NEJM 2011

11 New Anticoagulants vs Wafarin All-cause Mortality Dabigatran 150 mg b.i.d. Dabigatran 110 mg b.i.d. Rivaroxaban 20 mg o.d. Abixaban 5 mg b.i.d New Anticoagulant Warfarin Better Better Connolly S et al NEJM 2009; Patel M et al NEJM 2011; Granger C et al NEJM 2011

12 My Opponent Likely Approach Stable VKA therapy TTR Efficient Coagulation Clinic or Home INR monitoring Money

13 Primary Efficacy Outcome Stroke and non-cns Embolism Age Sex <75 75 Male Female CHADS Race BMI (kg/m 2 ) Creatinine Clearance (ml/min) White Black Asian >35 < >80 Prior Stroke/ TIA/ Non-CNS Systemic Embolism Region Prior VKA Use* Yes No North America Latin America West Europe East Europe Asia Pacific Yes No Rivaroxaban better Warfarin better Rivaroxaban better Warfarin better * 62-63% of patients Based on Safety On Treatment Population

14 My Opponent Likely Approach Stable VKA therapy TTR Efficient Coagulation Clinic or Home INR monitoring Money

15 SystemaQc US Overview Percentage of INR Time In TherapeuQc Range AC Clinic Based Warfarin Dosing Samsa, 2000 (n=43) Menzin, 2005 (n=600) Hylek, 2007 (n=306) Nichol, 2008 (n=351) Subtotal AC Clinic Community Based Warfarin Dosing Samsa, 2000 (n=61) Samsa, 2000 (n=125) McCormick, 2001 (n=174) Matchar, 2003 (n=363) Matchar, 2003 (n=317) Matchar, 2003 (n=317) Go, 2003 (n=7445) Shen, 2007 (n=11016) Nichol, 2008 (n=756) Subtotal Community Based Overall Effect 0.60 ( ) 0.62 ( ) 0.58 ( ) 0.68 ( ) 0.63 ( ) 0.47 ( ) 0.36 ( ) 0.51 ( ) 0.56 ( ) 0.49 ( ) 0.52 ( ) 0.63 ( ) 0.55 ( ) 0.42 ( ) 0.51 ( ) 0.55 ( ) Baker W, et al. J Manag Care Pharm 2009; 15: Time in TherapeuQc Range (95% CI) CC 15

16 Primary Efficacy Endpoint by Center TTR ROCKET AF/RE LY/ARISTOTLE Treatment Group n/j (rate) Warfarin n/j (rate) p value (interacqon) ROCKET AF % 45/1735 (1.77) 62/1689 (2.53) % 53/1746 (1.94) 63/1807 (2.18) % 54/1734 (1.90) 62/1758 (2.14) % 37/1676 (1.33) 55/1826 (1.80) RE LY (Dabigatran 150 mg) 0.20 <57.1% 32/1509 (1.1) 54/1504 (1.92) % 32/1526 (1.04) 62/1514 (2.06) % 31/1484 (1.04) 45/1487 (1.51) >72.6% 38/1514 (1.27) 40/1509 (1.34) ARISTOTLE 0.29 < 58.0% 70/2266 (1.75) 88/2252 (2.28) % 54/2251 (1.30) 68/2278 (1.61) % 51/2256 (1.21) 65/2266 (1.55) > 72.2 % 36/2266 (0.83) 44/2251 (1.02) WallenQn L, et al. Lancet 2010;376: Granger, CB. Results of the ARISTOTLE Trial. ESC, France, August, 2011 Rate = number of events per 100 paqent years n = subjects with events; J = number of subjects in each subgroup Hazard RaQo (95% CI) Study Drug Favors Warfarin CC 16

17 My Opponent Likely Approach Stable VKA therapy TTR Efficient Coagulation Clinic or Home INR monitoring Money

18 Warfarin Use in Eligible Patients US Systematic Overview Baker WL et al. JMCP 2009; 15:

19 THINRS: Primary Endpoint Death, Major Bleeding, Stroke Matchar, NEJM, 2010

20 My Opponent Likely Approach Stable VKA therapy TTR Efficient Coagulation Clinic or Home INR monitoring Costs and Cost-Effectiveness

21 Cost Effectiveness Warfarin vs Novel Agents The costs associated with warfarin are well described: Cost of drug Cost of monitoring Cost of adverse events The cost of dabigatran is known Several investigators* have published cost-effectiveness analyses No patient level cost-effective analyses has been published *Shah, Circulation 2011; Pink BMJ 2011 Freeman, Ann Intern Med 2011

22 Cost-effectiveness of Fixed-dose Dabigatran Freeman, Ann Intern Med 2011

23 A Back of the Envelope Assessment of the Potential Cost Effectiveness of Dabigatran (Pradaxa) in Non- Valvular Atrial Fibrillation C. Michael Gibson, M.S., M.D.

24 Key Points Better Outcomes Comparable or Better Overall Bleeding Significant Reduction ICH Convenience Favorable Cost- Effectiveness Warfarin Novel Agents

25 New Era for Antithrombotic Therapy Non-ST Elevation ST Elevation Acute Coronary Syndromes Venous Disease / PE Prophylactic Mechanical Valves Stents BMS/DES Atrial Fibrillation

26 100 Initial Priority Topics Comparative Effectiveness Research # 1 Compare the effectiveness of treatment strategies for atrial fibrillation including surgery, catheter ablation, & pharmacologic treatment. IOM. Initial Priorities for Comparative Effectiveness Research. June 30,

27 Ideal Atrial Fibrillation Anticoagulant Efficacy DRUG (s)?? Safety Ease

RR 0.88 (95% CI: 0.77 1.00) P=0.051 (superiority) 3.75

RR 0.88 (95% CI: 0.77 1.00) P=0.051 (superiority) 3.75 ALL-CAUSE MORTALITY RR 0.88 (95% CI: 0.77 1.00) P=0.051 (superiority) Rate per year (%) 5.0 4.0 3.0 2.0 1.0 0 3.64 D150 mg BID 3.75 D110 mg BID RR 0.91 (95% CI: 0.80 1.03) P=0.13 (superiority) 4.13 Warfarin

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