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NOVEL ANTICOAGULANTS

NOVEL ANTICOAGULANTS. Vladimir Bogin, MD October 5, 2008. Agenda. Review Disease States Review Current Treatment Options Review Novel Anticoagulants. Anticoagulation: Who and When. Venous thromboembolism DVT and PE (Rx and prophylaxis) Arterial thromboembolism

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NOVEL ANTICOAGULANTS

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  1. NOVEL ANTICOAGULANTS Vladimir Bogin, MD October 5, 2008

  2. Agenda • Review Disease States • Review Current Treatment Options • Review Novel Anticoagulants

  3. Anticoagulation: Who and When • Venous thromboembolism • DVT and PE (Rx and prophylaxis) • Arterial thromboembolism • Atrial Fibrillation/Flutter • Prosthetic mechanical valves • Severe CHF • Pulmonary hypertension • AV fistulas * Acute coronary syndromes

  4. Venous thromboembolism Prophylaxis: • post-surgery, medically ill, oncolological patients • Lovenox, Fondoparinox, SQ Heparin, Warfarin for 12-21 days Treatment • “Provoked” (i.e LE surgery, fractures) • Warfarin for 3-6 months with initial “bridging” • “Unprovoked” • 12 months of Warfarin (Lovenox for oncological patients) • Lifelong in hypercoagulable states • Factor V Leiden, Hyperhomocysteinemia, factor VIII mutations

  5. Arterial thromboembolism • Atrial fibrillation – lifelong anticoagulation (INR 2-3) • CHADS2 score>1 • Only 50-60% of eligible patients are anticoagulated • Prosthetic mechanical valves (INR2.5-3.5) • CHF: usually EF<15%, history of embolic events, LV thrombus • Pulmonary hypertension

  6. Treatment Options • Warfarin • 57 years on the market • “Rat poison” • Monitoring is a nightmare, multiple drug and food interactions • Lovenox (ATIII and factor Xa) • Fondaparinox (Arixtra) – indirect Xa inhibitor • Direct Thrombin Inhibitors • Argatroban, Bivalirudin (Angiomax), Hirudin • Usually in HIT, ACS • IIb/IIIa inhibitors (i,.e Reopro, Integrelin, Aggrostat) • Only in ACS

  7. Novel Oral Anticoagulants • Rivaroxaban (Xalerto) – factor Xa inhibitor • Approved for DVT prophylaxis in Europe • Dabigatran (Pradaxa) – Direct thrombin Inhibitor • On the market in Europe and in Canada • Apixaban - factor Xa inhibitor • Advantages: • No monitoring required • No food or drug interaction • Rapid onset of action and short half-life

  8. US AF Registry: Timelines US AFib registry enrollment starts US AFib registry study complete US AFib registry enrollment ends Pradaxa AFib Launch Q3 Q4 2009 Q2 Q3 Q4 2010 Q2 Q3 Q4 • Approvals • US • Corp Initiate publications Publications at US Congresses Interim publications Identify Advisory Panel Develop protocol Identify CRO

  9. Thank you

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