Rivaroxaban A new oral anti-thrombotic Dr. Hisham Aboul-Enein Professor of Cardiology Benha University 12/1/2012

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1 Rivaroxaban A new oral anti-thrombotic Dr. Hisham Aboul-Enein Professor of Cardiology Benha University 12/1/2012

2 Agenda Ideal anticoagulant. Drawbacks of warfarin. Rivaroxaban in clinical trails. Present status of rivaroxaban.

3 The Ideal anticoagulant Oral, fixed dosage, once daily. High efficacy, rapid onset and offset. Predictable dose response + Wide TW. Simple pharmacology. No need for monitoring. Available antidote. No or little interaction with food or drugs. Acceptable safety profiles.

4 Warfarin is not ideal? Narrow therapeutic window Unpredictable dose response Complex Pharmacology. Need frequent monitoring and dose adjustment Slow onset and offset of action. Frequent food and drugs interactions.

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6 Anticoagulants in development Agent Company Phase Dabigatran Boehringer 3 DTI AZD 0837 Astra-zinca 2 DTI MCC 977 Mitsubishi 2 DTI Rivaroxaban Bayer 3 DFXaI Apixaban Bristol, Sqb, Pfz 3 DFXaI Betrixaban Portola 2 DFXaI Edoxaban Daichi Sankyo 3 DFXaI YM 150 Astellas 2 DFXaI TAK-442 Takeda 2 DFXaI

7 Direct Factor Xa inhibition XIIa Tissue factor XIa IXa Xa Factor II (prothrombin) VIIa Rivaroxaban Apixaban YM150 DU-176b LY Betrixaban TAK 442 Fibrinogen Fibrin clot

8 Rivaroxaban Inhibition of Factor Xa activity (%) Specific, competitive, direct FXa inhibitor Inhibits free and clotassociated FXa activity 100 Prolongs time to thrombin generation Inhibits peak thrombin generation Reduces the total amount of thrombin generated Free FXa Prothrombinase activity Clot-associated FXa Rivaroxaban (nm) Perzborn et al. J Thromb Haemost 2005; ICT 2004; Depasse et al. ISTH 2005; Kubitza et al. Clin Pharmacol Ther 2005; Br J Clin Pharmacol, 2007; Graff et al. In press

9 Rivaroxaban: oral direct Factor Xa inhibitor Predictable pharmacology Low risk of drug interactions No requirement for monitoring Peak 3hrs after oral 4.9 hrs half life 80% bioavailability 66% renal excretion O N N O Cl O H S N O Rivaroxaban rivaroxaban O Perzborn et al. 2005; Kubitza et al. 2005; 2006; 2007; Roehrig et al, 2005

10 Rivaroxaban phase 3 trials Compar No.pat Expec Acronym AF VKA 14, Rocket-AF VTE, 1ry LMWH 8,500 8, Record1-4 Magellan VTE, ttt LMWH/K 6, Einstein VTE, 2ry Placebo 1, Einstein ext Post ACS Placebo 16,000 Unkn. Atlas/TIMI

11 RECORD: phase III program Rivaroxaban 10 mg od was compared with enoxaparin in 12,729 patients worldwide Study Duration of rivaroxaban therapy Dose and duration of enoxaparin therapy THR 5 weeks 40 mg od; 5 weeks THR 5 weeks 40 mg od; 2 weeks TKR 2 weeks 40 mg od; 2 weeks TKR 2 weeks 30 mg q12h; 2 weeks

12 Efficacy endpoints Primary Total venous thromboembolism (VTE): any deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE), and all-cause mortality Secondary Major VTE: proximal DVT, non-fatal PE, and VTE-related death DVT: any, proximal, distal Symptomatic VTE All endpoints were adjudicated centrally by independent, blinded committees

13 Incidence (%) RECORD1: summary 5 4 Total VTE RRR 70% Rivaroxaban 10 mg once daily Enoxaparin 40 mg once daily 3 2 Major VTE RRR 88% % 1.1% 2.0% 0.2% Symptomatic VTE Major bleeding 0.5% 0.3% 0.1% 0.3%

14 Summary for record program Major advantages over traditional anticoagulants: no requirement for anticoagulant monitoring low drug drug interaction potential possibility to use in both the acute and chronic settings. This drug provides an alternative to subcutaneous enoxaparin for the prevention of VTE after THR and TKR. Rivaroxaban showed superior efficacy over enoxaparin even in symptomatic DVT, without significant differences in major bleeding..

15 Phase 3 for ttt of DVT /PE EINSTEIN-DVT and EINSTEIN-PE multicenter, randomized, open-label studies. Patients with confirmed symptomatic DVT (for the DVT study) or PE (for the PE study) Ptns randomized to receive standard therapy (enoxaparin, followed by a VKA) or rivaroxaban. Rivaroxaban is being administered at 15 mg bid for the first 3 wks of treatment, after which patients will receive a dose of 20 mg od for a predefined treatment period of 3, 6 or 12 months.

16 IN DVT study 3,449 patients were randomized. The primary efficacy outcome: recurrent symptomatic VTE, occurred in 2.1% of the rivaroxaban group versus 3.0% of the enoxaparin group (p < for noninferiority, p = for superiority). Recurrent deep venous thromboembolism occurred in 0.8% versus 1.6%, nonfatal pulmonary embolism occurred in 1.2% versus 1.0%, respectively. The primary safety outcome, major and clinically relevant nonmajor bleeding, occurred in 8.1% of the rivaroxaban group versus 8.1% of the enoxaparin group.

17 Phase 3 for ttt of DVT /PE (2ry prevention of DVT or PE) The EINSTEIN-EXTENSION study Recruited patients who have been treated for 6 or 12 months with rivaroxaban or a VKA. These patients were randomized to receive double-blind rivaroxaban 20 mg od Or placebo for a further 6 or 12 months. There was a risk reduction of 82% for rivaroxaban vs placebo for recurrent symptomatic VTE.

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19 Cumulative event rate (%) Primary Efficacy Outcome Stroke and non-cns Embolism Event Rate Rivaroxaban Warfarin Warfarin Rivaroxaban HR (95% CI): 0.79 (0.66, 0.96) P-value Non-Inferiority: < Days from Randomization No. at risk: Rivaroxaban Warfarin Event Rates are per 100 patient-years Based on Protocol Compliant on Treatment Population

20 Primary Safety Outcomes Major and non-major Clinically Relevant Rivaroxaban Event Rate Warfarin Event Rate HR (95% CI) P- value (0.96, 1.11) Major (0.90, 1.20) Non-major Clinically Relevant (0.96, 1.13) Event Rates are per 100 patient-years Based on Safety on Treatment Population

21 Efficacy: Summary Rivaroxaban was non-inferior to warfarin for prevention of stroke and non-cns embolism. Rivaroxaban was superior to warfarin while patients were taking study drug. By intention-to-treat, rivaroxaban was non-inferior to warfarin but did not achieve superiority. Safety: Similar rates of bleeding and adverse events. Less ICH and fatal bleeding with rivaroxaban. Conclusion: Rivaroxaban is a proven alternative to warfarin for moderate or high risk patients with AF.

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23 The ATLAS-ACS 2 TIMI 51 results were presented AHA 2011 Scientific Sessions in Orlando Both rivaroxaban doses reduced the 1ry end point of CV death/mi/stroke, at the cost of increased bleeding rates. The 2.5-mg twice-daily dose had the better benefit/risk balance, due to a lower bleeding risk than the 5-mg twice-daily dose. The overall results showed a significant 16% reduction in the primary efficacy end point for the two doses combined vs placebo There was a threefold increase in major bleeding and intracranial hemorrhage but no significant increase in fatal bleeding.

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25 Unresolved issues Long-term efficacy and safety? Cost and compliance? Available antidote? Specific drug monitoring test? Tendency for increased bleeding? Uses in renal failure and in patients with prosthetic valves?

26 Present status Rivaroxaban was approved in 2009 for the prevention of VTE after major orthopaedic surgery. In AF, Warfarin will remain in use for certain subsets of patients; including those with mechanical heart valves. In non valvular AF Rivaroxaban is a proven alternative to warfarin for moderate or high risk patients with AF.

27 Present status (cont.) The revaroxaban was non inferior to enoxaparin in the ttt of DVT in EINSTEIN DVT trial Phase 3 trials as regards ACS, showed 16 % reduction in 1ry efficacy end points with 3 fold increase in non fatal bleeding

28 D:\

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