Xarelto (Rivaroxaban): Effective in a broad spectrum. Joep Hufman, MD Medical Scientific Liason

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1 Xarelto (Rivaroxaban): Effective in a broad spectrum Joep Hufman, MD Medical Scientific Liason

2 Xarelto : Effective in a broad spectrum Introduction Therapeutic areas SPAF VTE Prevention VTE treatment Practical issues Monitoring? Antidote? Switch? SPAF VTE Treatment VTE Prevention Discussion/BI

3 Introduction What is coagulation? Why? Entities? Mechanisms anticoagulant treatment?

4 Introduction: Xarelto Selective, direct Factor Xa inhibitor 1 High oral bioavailability 2 Cmax: 2-4 hrs 3 Half-life: 7-11 hrs 2 4 Dual mode of elimination: 5 1/3 of active drug excreted unchanged by the kidneys 2/3 of drug metabolized by liver; 50% is excreted renally, 50% via the hepatobiliary route Interactions: Ritonavir Ketokonazole TF/VIIa X IXa VIIIa Va Xa II IIa Fibrinogen IX Rivaroxaban Fibrin 1. Perzborn et al, 2005; 2. Kubitza et al, 2005a; 3. Kubitza et al, 2005b; 4. Kubitza et al, 2008; 5. Weinz et al, 2009 Adapted from Weitz et al, 2005; 2008

5 Introduction: Xarelto Metabolism CYP3A4 Pgp Bioavailability % Distribution 92-95% albumin binding Vss 50L SMPC

6 Introduction Contra indications Renal clearance <15ml/min Active bleeding Pregnancy Breastfeeding Liver disease with coagulapathy Caution Strong or moderate CYP3A4 and Pgp inhibitors or inductors! Ketoconazol Fluconazol Ritonavir Other anticoagulants and platelet inhibitors SMPC

7 Therapeutic areas SPAF VTEpos VTEx

8 Therapeutic areas SPAF SPAF: Stroke prevention in Atrial fibrillation Strokes are major healthcare burden 80% of strokes are ischaemic 20% of strokes caused by AF 1 AF related strokes are more prone to reoccur and have higher mortality rates 1,2 1: ESC guidelines 2010, 2: Marini et al, 2005

9 ROCKET AF Study Design Randomized, double-blind, double-dummy, event-driven Non-valvular AF History of stroke, TIA or non-cns SE OR 2* of the following: CHF Hypertension Age 75 years Diabetes N=14,264 R Rivaroxaban 20 mg once daily** Warfarin target INR 2 3 End of study 30-day follow-up ~11 41 months*** *Enrollment of patients with 2 risk factors or without prior stroke/tia or non-cns SE was limited to 10% **Patients with CrCl ml/min: 15 mg rivaroxaban once daily ***Duration of therapy varied for each patient as study was event-driven ROCKET AF Study Investigators. Am Heart J 2010; Patel et al. NEJM 2011, August 10th epub ahead of print

10 ROCKET AF Study Endpoints Primary efficacy endpoint Composite of stroke and systemic embolism (SE) Secondary efficacy endpoints Composite of stroke, SE, or cardiovascular death Composite of stroke, SE, cardiovascular death, or MI Individual components of the above endpoints Principal safety endpoint Composite of major and non-major clinically relevant bleeding ROCKET ROCKET AF AF Study Study Investigators. Investigators. Am Am Heart Heart J J 2010; 2010; Patel Patel et et al. al. NEJM NEJM 2011, 2011, August August 10th 10th epub epubahead of of print print

11 Primary Efficacy Outcome Rivaroxaban Warfarin Event Rate Event Rate HR (95% CI) P-value On Treatment (0.65,0.95) ITT (0.74,1.03) Rivaroxaban better Warfarin better Event Rates are per 100 patient-years Based on Safety on Treatment or Intention-to-Treat thru Site Notification populations ROCKET AF Study Investigators. Am Heart J 2010; Patel et al. NEJM 2011, August 10th epub ahead of print

12 ROCKET AF ROCKET AF Study Investigators. Am Heart J 2010; Patel et al. NEJM 2011, August 10th epub ahead of print

13 ROCKET AF Conclusions Xarelto at least as effective in AF as warfarin No monitoring Once daily oral dosing Few interactions Food Drugs GI Bleeds ICH ROCKET AF Study Investigators. Am Heart J 2010; Patel et al. NEJM 2011, August 10th epub ahead of print

14 Therapeutic areas VTE prevention In major orthopedic surgery Damage Immobilisation Hypercoaguble state Patients Increased VTE risk! Untreated 40-80% 1 ACCP: at least 10 days prophylaxis* 2 * Prophylaxis: LMWH, VKA or fondaparinux 1: Cayley, 2007; 2: ACCP 2008

15 RECORD1: Study design R Rivaroxaban 10 mg od S U R 6 8 hours post-surgery G E 6 8 hours post-surgery R Y Evening before surgery Enoxaparin 40 mg od Mandatory bilateral venography Day 1 Day 36±4 Last dose, day before venography F O LL O W U P Up to Day 65 Inclusion criteria Patients aged 18 years, scheduled to undergo elective THR 4591 patients Erkisson et al 2008 Major exclusion criteria Active bleeding or high risk of bleeding Significant liver disease Anticoagulant therapy that could not be stopped Use of HIV-protease inhibitors

16 VTE prevention Major Orthopedic surgery RECORD program 1dd 10mg vs LMWH Superior protection Similar bleeding profile 30 clinics using Xarelto in stead of LMWH in NL! Over pts treated! Erkisson et al 2009

17 Therapeutic areas VTE Treatment VTE is a major healthcare issue 2004 model 1 (France, Germany, Italy, Spain, Sweden, UK): cases of DVT cases of PE VTE related deaths Estimated VTE incidence 1 to 2 per 1000 people 2 Current standard of care? Bridging* followed by VKA therapy for 3, 6 or 12 months 3 EINSTEN program Bridging is LMWH, UFH or fondaparinux for 5 days 1: Cohen et al, 2007, 2: Oudega Huisarts wet. 2008, 3 ACCP 2008

18 VTE treatment EINSTEIN DVT PE EXT Confirmed symptomatic DVT without symptomatic PE N=3,449 R Treatment period: 3, 6 or 12 months Rivaroxaban 15 mg bid Enoxaparin 1.0 mg/kg bid 5 days, followed by VKA INR range 2 3 Day 1 Day 21 Rivaroxaban 20 mg od 30-day observation period Berkowitz et al 2009

19 DVT treatment DVT/PE EINSTEIN programme 1 DVT treatment finished 1 Cumulative event rate (%) Time to event (days) Enoxaparin/VKA Rivaroxaban Xarelto equal eficcacy and safety 1 1: Berkowitz et al 2009

20 Practical issues Monitoring? Antidote? Switch?

21 Practical issues Monitoring SMPC: PT with Neoplastin No relation with clinical effect! Antidote: Short T1/2: Quit Xarelto Stem bleeding Fk.cvz.nl: Novoseven Eerenberg et al: Cofact SMPC,

22 Practical issues

23 Practical issues Switch VKA Xarelto Quit VKA, monitor INR, when INR is <3 start Xarelto (SPAF, for DVT INR <2.5) LMWH Xarelto Take first dose of Xarelto when next dose of LMWH should be taken Xarelto VKA Start VKA, after 2 days check INR INR >2 quit Xarelto SMPC

24 Conclusions Xarelto has a broad indication area At least as safe and effective as current standard of treatment No monitoring No dose adjustment Few interactions Once daily oral dosing What do you think?

25 Thank you for your attention Questions?

26 Thank you! Joep Hufman

27 Forward-Looking Statements This presentation may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer s public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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