Analysing Apixaban: Potential Growth Driver for Pfizer and Bristol Myers Squibb. Tro Kalayjian Chief Medical Analyst Chimera Research Group

Size: px
Start display at page:

Download "Analysing Apixaban: Potential Growth Driver for Pfizer and Bristol Myers Squibb. Tro Kalayjian Chief Medical Analyst Chimera Research Group"

Transcription

1 Analysing Apixaban: Potential Growth Driver for Pfizer and Bristol Myers Squibb Tro Kalayjian Chief Medical Analyst Chimera Research Group

2 Prevalence of AFib in the US is expected to increase upwards of 5.3 million by 2050

3 Limitations of current anticoagulants Heparins Parenteral administration Indirect mode of action Interact with other proteins Unable to inhibit clot-bound thrombin Heparin-induced thrombocytopenia Vitamin K antagonists Slow onset and offset of action Dietary restrictions Interactions with co-medications Narrow therapeutic window Require monitoring and individual dosing

4 Desirable qualities of a new anticoagulant As or more effective than current agents As or safer than current agents Oral Fixed dosing Minimal food and drug interactions Predictable anticoagulant response (no monitoring) Rapid onset and offset of action Reversible

5 New Drugs & Product Candidates Dabigatran - Oral Direct Thrombin Inhibitor Approved Boehringer Ingelhemim Rivaroxaban Oral Factor Xa Inhibitor Recent FDA Approval - JNJ Apixiban Oral Factor Xa Inhibitor PFE BMY Thomson Reuters forecast consensus sales forecast to reach $1.6 billion in 2015

6 Key features of new oral anticoagulants

7 Review of Clotting Cascade

8 Origins of new anticoagulants Factor Xa inbitors found from salivary extracts of Mexican leach, Heamenteria officinalis Direct Thrombin inhibitors found from TAP extracts of tick Omithodoros moubata

9 Aristotle - Study Overview - Apixiban Research Hypothesis: Apixaban is noninferior to warfarin for prevention of stroke (ischemic or hemorrhagic or of unspecified type) or systemic embolism in subjects with atrial fibrillation & additional risk factor(s) for stroke. Primary Objective: To determine if apixaban is noninferior to warfarin (INR target range ) in the combined endpoint of stroke (ischemic or hemorrhagic or of unspecified type) and systemic embolism, in subjects with AF and at least one additional risk factor for stroke Key Secondary Objectives: To determine, in subjects with AF and at least one additional risk factor for stroke, if apixaban is superior to warfarin (INR target range ) for, - The combined endpoint of stroke (hemorrhagic, ischemic, or of unspecified type) and systemic embolism, - Major bleeding (ISTH) -All-cause death Study Design: Randomized, double-blind, double-dummy, parallel-arm study assessing apixaban and warfarin with titration based on central monitoring of the international normalized ratio (INR). Subjects will receive active apixaban tablets and placebo warfarin tablets or placebo apixaban tablets and active warfarin tablets

10 Inclusion Criteria Eligible patients had atrial fibrillation or flutter at enrollment or two or more episodes of atrial fibrillation or flutter by electrocardiography, at least 2 weeks apart in the 12 months before enrollment. In addition, at least one of the following risk factors for stroke was required: An age of at least 75 years Previous stroke or transient ischemic attack Systemic embolism Symptomatic heart failure within the previous 3 months left ventricular ejection fraction of no more than 40% Diabetes mellitus Hypertension requiring pharmacologic treatment

11 Exclusion Criteria Atrial fibrillation due to a reversible cause Moderate or severe mitral stenosis Conditions other than Afib that required anticoagulation (e.g., a prosthetic heart valve) Stroke within the previous 7 days a need for aspirin at a dose of >165 mg a day or for both aspirin and clopidogrel Severe renal insufficiency (serum Cr level of >2.5 mg per deciliter [221 µmol/liter]) Calculated creatinine clearance of <25 ml per minute

12 Notable Facts about Trial From December 19, 2006, through April 2, 2010, the study recruited 18,201 patients at 1034 clinical sites in 39 countries. The mean follow up time was 18 months Data on vital status at the end of the trial were missing for 380 patients (2.1%). The absence of data on vital status was due to withdrawal of consent in the case of 92 patients in the apixaban group (1.0%) and 107 patients in the warfarin group (1.2%) and was due to loss to follow-up in the case of 35 patients in the apixaban group (0.4%) and 34 in the warfarin group (0.4%). An algorithm was provided to manage temporary discontinuations of the study drug around the time of interventional procedures while maintaining concealment of the group assignments

13

14 Granger Financial Ties

15 Consort Diagram

16 Baseline Characteristics of the Patients

17 Kaplan Meier Curves Primary Efficacy & Safety Outcomes

18 Relative Risks of the Primary Efficacy and Safety Outcomes According to Major Pre-specified Subgroups

19 Efficacy Outcomes

20 Bleeding Outcomes and Net Clinical Outcomes

21 Interpretation of Results In patients with atrial fibrillation and at least one additional risk factor for stroke, the use of apixaban, as compared with warfarin, significantly reduced the risk of stroke or systemic embolism by 21%, major bleeding by 31%, and death by 11%. For every 1000 patients treated for 1.8 years, apixaban, as compared with warfarin, prevented a stroke in 6 patients (4 hemorrhagic, 2 ischemic), major bleeding in 15 patients, and death in 8 patients. By switching to apixiban over wrafar, roughly every two years, for every 30 patients treated, 1 serious events will be prevented. In an average lifetime, use of apixaban over warfarin, for every 10 patients treated, 1 serious event will be prevented.

22 Criticisms Dose selection - A reduced dose of apixaban (2.5 mg twice daily) was administered in 428 patients in the apixaban group (4.7%) Population Selection excluding critically ill and elderly who are at the most risk of bleeding Antidote No antidote currently exists for Factor Xa inhibitors Inferiority trial although their were superiority secondary outcomes Financial ties all investigators benefitted from the trial

23 Expectations Considering early Xarelto approval (rivaroxaban), we expect that Apixiban will be approved in FY 2012 We expect peak sales of $2 Billion in US alone, $3 Billion worldwide Given compelling data, and increased awareness, we expect rapid uptake Patients prefer agents that do not have to be monitored Although no antidote exists, FFP has been used for rapid reversal We expect approval for Pfizer and Bristol Myers.

24 Chimera Research Group Comments?

Events after discontinuation of randomized treatment at the end of the ARISTOTLE trial

Events after discontinuation of randomized treatment at the end of the ARISTOTLE trial Events after discontinuation of randomized treatment at the end of the ARISTOTLE trial Christopher Granger, John Alexander, Michael Hanna, Jerry Wang, Puneet Mohan, Jack Lawrence, Elaine Hylek, Jack Ansell,

More information

Debate: New Generation Anti-Coagulation Agents are a Better Choice than Warfarin in the Management of AF

Debate: New Generation Anti-Coagulation Agents are a Better Choice than Warfarin in the Management of AF Debate: New Generation Anti-Coagulation Agents are a Better Choice than Warfarin in the Management of AF Bradley P. Knight, MD Director of Cardiac Electrophysiology Bluhm Cardiovascular Institute Northwestern

More information

Update on Oral Anticoagulants. Dr. Miten R. Patel Cancer Specialists of North Florida Cell

Update on Oral Anticoagulants. Dr. Miten R. Patel Cancer Specialists of North Florida Cell Update on Oral Anticoagulants Dr. Miten R. Patel Cancer Specialists of North Florida Cell 904-451-9820 Email miten.patel@csnf.us Overview Highlights of the 4 new approved oral anticoagulants Results from

More information

Anticoagulation Beyond Coumadin

Anticoagulation Beyond Coumadin Anticoagulation Beyond Coumadin Saturday, September 21, 2013 Crystal Mountain Resort and Spa Pratik Bhattacharya MD, MPH Stroke Neurologist, Michigan Stroke Network; Assistant Professor of Neurology; Wayne

More information

Stepheny Sumrall, FNP, AGACNP Cardiovascular Clinic of Hattiesburg

Stepheny Sumrall, FNP, AGACNP Cardiovascular Clinic of Hattiesburg Novel Oral Anticoagulants Analyzing Clinical Trial Findings of the Efficacy and Safety Profiles of Novel Anticoagulants for the Treatment of Atrial Fibrillation and Prevention of Stroke Stepheny Sumrall,

More information

Individual Therapeutic Selection Of Anti-coagulants And Periprocedural. Miguel Valderrábano, MD

Individual Therapeutic Selection Of Anti-coagulants And Periprocedural. Miguel Valderrábano, MD Individual Therapeutic Selection Of Anti-coagulants And Periprocedural Management Miguel Valderrábano, MD Outline Does the patient need anticoagulation? Review of clinical evidence for each anticoagulant

More information

Pros and Cons of Individual Agents Based on Large Trial Results: RELY, ROCKET, ARISTOTLE, AVERROES

Pros and Cons of Individual Agents Based on Large Trial Results: RELY, ROCKET, ARISTOTLE, AVERROES Pros and Cons of Individual Agents Based on Large Trial Results: RELY, ROCKET, ARISTOTLE, AVERROES Ralph L. Sacco, MS MD FAAN FAHA Olemberg Family Chair in Neurological Disorders Miller Professor of Neurology,

More information

ESC Congress 2012, Munich

ESC Congress 2012, Munich ESC Congress 2012, Munich Anticoagulation in Atrial Fibrillation 2012: Which Anticoagulant for Which Patient? Stefan H. Hohnloser J.W. Goethe University Frankfurt am Main S.H.H. has served as a consultant,

More information

Is Apixaban Effective for the Prevention of Stroke in Patients With Non-Valvular Atrial Fibrillation?

Is Apixaban Effective for the Prevention of Stroke in Patients With Non-Valvular Atrial Fibrillation? Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Scholarship Student Dissertations, Theses and Papers 2014 Is Apixaban Effective for the Prevention

More information

New Anticoagulants Therapies

New Anticoagulants Therapies New Anticoagulants Therapies Rachel P. Rosovsky, MD, MPH October 22, 2015 Conflicts of Interest No disclosures 2 Agenda 3 Historical perspective Novel oral anticoagulants Stats Trials Approval Concerns/Limitations

More information

ARISTOTLE Demonstrated that ELIQUIS is the First Oral Anticoagulant to Significantly Reduce All-Cause Death

ARISTOTLE Demonstrated that ELIQUIS is the First Oral Anticoagulant to Significantly Reduce All-Cause Death ELIQUIS (apixaban) was Superior to Warfarin for the Reduction of Stroke or Systemic Embolism with Significantly Less Major Bleeding in Patients with Atrial Fibrillation in Phase 3 ARISTOTLE Trial ARISTOTLE

More information

Clinical issues which drug for which patient

Clinical issues which drug for which patient Anticoagulants - a matter of heart! Towards a bright future? Clinical issues which drug for which patient Sabine Eichinger Dept. of Medicine I Medical University of Vienna/Austria Conflicts of interest

More information

Joshua D. Lenchus, DO, RPh, FACP, SFHM Associate Professor of Medicine and Anesthesiology University of Miami Miller School of Medicine

Joshua D. Lenchus, DO, RPh, FACP, SFHM Associate Professor of Medicine and Anesthesiology University of Miami Miller School of Medicine Joshua D. Lenchus, DO, RPh, FACP, SFHM Associate Professor of Medicine and Anesthesiology University of Miami Miller School of Medicine Antithrombotics Antiplatelets Aspirin Ticlopidine Prasugrel Dipyridamole

More information

Bios 6648: Design & conduct of clinical research

Bios 6648: Design & conduct of clinical research Bios 6648: Design & conduct of clinical research Section 1 - Specifying the study setting and objectives 1. Specifying the study setting and objectives 1.0 Background Where will we end up?: (a) The treatment

More information

Asif Serajian DO FACC FSCAI

Asif Serajian DO FACC FSCAI Anticoagulation and Antiplatelet update: A case based approach Asif Serajian DO FACC FSCAI No disclosures relevant to this talk Objectives 1. Discuss the indication for antiplatelet therapy for cardiac

More information

Engage AF-TIMI 48. Edoxaban in AF: What can we expect? Cardiology Update John Camm. St. George s University of London United Kingdom

Engage AF-TIMI 48. Edoxaban in AF: What can we expect? Cardiology Update John Camm. St. George s University of London United Kingdom Cardiology Update 2013 N S N O N H O H N S1 pocket Aryl binding N site O O N H N Cl Engage AF-TIMI 48 Edoxaban in AF: What can we expect? John Camm St. George s University of London United Kingdom Advisor

More information

Reversal of Novel Oral Anticoagulants. Angelina The, MD March 22, 2016

Reversal of Novel Oral Anticoagulants. Angelina The, MD March 22, 2016 Reversal of Novel Oral Anticoagulants Angelina The, MD March 22, 2016 Argatroban Bivalirudin Enoxaparin Lepirudin Heparin Dabigatran Apixaban 1939 1954 1998 2000 1999 2001 10/2010 7/2011 12/2012 1/2015

More information

What s new with DOACs? Defining place in therapy for edoxaban &

What s new with DOACs? Defining place in therapy for edoxaban & What s new with DOACs? Defining place in therapy for edoxaban & Use of DOACs in cardioversion Caitlin M. Gibson, PharmD, BCPS Assistant Professor, Department of Pharmacotherapy University of North Texas

More information

Oral Anticoagulants Update. Elizabeth Renner, PharmD, BCPS, BCACP, CACP Outpatient Cardiology and Anticoagulation

Oral Anticoagulants Update. Elizabeth Renner, PharmD, BCPS, BCACP, CACP Outpatient Cardiology and Anticoagulation Oral Anticoagulants Update Elizabeth Renner, PharmD, BCPS, BCACP, CACP Outpatient Cardiology and Anticoagulation Objectives List the direct oral anticoagulant (DOAC) drugs currently available Describe

More information

IS THERE STILL A PLACE FOR VITAMINE K ANTAGONISTS?

IS THERE STILL A PLACE FOR VITAMINE K ANTAGONISTS? IS THERE STILL A PLACE FOR VITAMINE K ANTAGONISTS? J.Y. LE HEUZEY Georges Pompidou Hospital, René Descartes University, Paris H E G P Munich, August 27, 2012 Disclosure Consultant / Conferences / Advisory

More information

Anticoagulation Therapy in LTC

Anticoagulation Therapy in LTC Anticoagulation Therapy in LTC By: Cynthia Leung, RPh, BScPhm, PharmD. Clinical Consultant Pharmacist MediSystem Pharmacy Jun 11, 2013 Agenda Stroke and Bleeding Risk Assessment Review of Oral Anticoagulation

More information

FINAL CDEC RECOMMENDATION

FINAL CDEC RECOMMENDATION FINAL CDEC RECOMMENDATION APIXABAN (Eliquis Bristol-Myers Squibb Canada and Pfizer Canada Inc.) New Indication: Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation Recommendation:

More information

The INR: No Need Anymore? Daniel Blanchard, MD Professor of Medicine Director, Cardiology Fellowship Program UCSD Sulpizio Cardiovascular Center

The INR: No Need Anymore? Daniel Blanchard, MD Professor of Medicine Director, Cardiology Fellowship Program UCSD Sulpizio Cardiovascular Center The INR: No Need Anymore? Daniel Blanchard, MD Professor of Medicine Director, Cardiology Fellowship Program UCSD Sulpizio Cardiovascular Center What is the INR? Tissue Factor (Factor III) is added to

More information

Oral Anticoagulation Drug Class Prior Authorization Protocol

Oral Anticoagulation Drug Class Prior Authorization Protocol Oral Anticoagulation Drug Class Prior Authorization Protocol Line of Business: Medicaid P & T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review

More information

Technology appraisal guidance Published: 27 February 2013 nice.org.uk/guidance/ta275

Technology appraisal guidance Published: 27 February 2013 nice.org.uk/guidance/ta275 Apixaban for preventing enting stroke and systemic embolism in people with nonvalvular atrial fibrillation Technology appraisal guidance Published: 27 February 2013 nice.org.uk/guidance/ta275 NICE 2018.

More information

Conflict of interest statement

Conflict of interest statement Risk of stroke, systemic embolism or death according to heart failure and left ventricular function status in patients with atrial fibrillation: results of the ARISTOTLE trial J.J.V. McMurray 1, B. Lewis

More information

Results from RE-LY and RELY-ABLE

Results from RE-LY and RELY-ABLE Results from RE-LY and RELY-ABLE Assessment of the safety and efficacy of dabigatran etexilate (Pradaxa ) in longterm stroke prevention EXECUTIVE SUMMARY Dabigatran etexilate (Pradaxa ) has shown a consistent

More information

Digoxin And Mortality in Patients With Atrial Fibrillation With and Without Heart Failure: Does Serum Digoxin Concentration Matter?

Digoxin And Mortality in Patients With Atrial Fibrillation With and Without Heart Failure: Does Serum Digoxin Concentration Matter? Digoxin And Mortality in Patients With Atrial Fibrillation With and Without Heart Failure: Does Serum Digoxin Concentration Matter? Renato D. Lopes, MD, PhD, FACC on behalf of the ARISTOTLE Investigators

More information

Atrial Fibrillation: Risk Stratification and Treatment New Cardiovascular Horizons St. Louis September 19, 2015

Atrial Fibrillation: Risk Stratification and Treatment New Cardiovascular Horizons St. Louis September 19, 2015 Atrial Fibrillation: Risk Stratification and Treatment New Cardiovascular Horizons St. Louis September 19, 2015 Christopher E. Bauer, MD, FACC, FHRS SSM Health Heart & Vascular Care Clinical Cardiac Electrophysiology

More information

ADVANCES IN ANTICOAGULATION

ADVANCES IN ANTICOAGULATION ADVANCES IN ANTICOAGULATION The Clinicians Perspective Claudine M. Lewis Cardiologist OUTLINE Indications for anticoagulants Review - Physiology of Hemostasis Types of anticoagulants New anticoagulants

More information

6 th ACC-SHA Joint Meeting Jeddah, Saudi Arabia

6 th ACC-SHA Joint Meeting Jeddah, Saudi Arabia 6 th ACC-SHA Joint Meeting Jeddah, Saudi Arabia October 31 st - November 1 st, 2015 NOACS vs. Coumadin in Atrial Fibrillation: Is It Worth to Switch? Raed Sweidan, MD, FACC Consultant and Head of Cardiac

More information

Apixaban for stroke prevention in atrial fibrillation. August 2010

Apixaban for stroke prevention in atrial fibrillation. August 2010 Apixaban for stroke prevention in atrial fibrillation August 2010 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

Relevant Advances in Atrial Fibrillation

Relevant Advances in Atrial Fibrillation Gregory M Marcus, MD, MAS Assistant Professor of Medicine Division of Cardiology University of California, San Francisco Relevant Advances in Atrial Fibrillation Stroke Prophylaxis Antiarrhythmic Drug

More information

A Clinical Context Report

A Clinical Context Report Stroke Prevention in Atrial Fibrillation An Expert Commentary With Kenneth W. Mahaffey, MD A Clinical Context Report Stroke Prevention in Atrial Fibrillation Expert Commentary Jointly Sponsored by: and

More information

Dr Calum Young Cardiologist Tauranga

Dr Calum Young Cardiologist Tauranga Dr Calum Young Cardiologist Tauranga 8:30-9:25 WS #93: New Oral Anticoagulant Drugs and Management of AF 9:35-10:30 WS #105: New Oral Anticoagulant Drugs and Management of AF (Repeated) GPCME 2016: Anticoagulation

More information

KCS Congress: Impact through collaboration

KCS Congress: Impact through collaboration Stroke Prevention in Atrial Fibrillation (SPAF) in Kenya Elijah N. Ogola FACC University of Nairobi Kenya Cardiac Society Annual Scientific Congress Mombasa 28 th June 1 st July 2017 KCS Congress: Impact

More information

Atrial Fibrillation. 2 nd Annual National Hospitalist Conference San Antonio, TX September 7, 2018

Atrial Fibrillation. 2 nd Annual National Hospitalist Conference San Antonio, TX September 7, 2018 2 nd Annual National Hospitalist Conference San Antonio, TX September 7, 2018, MSc, FACP, SFHM Division of Hospital Medicine Henry Ford Hospital Detroit, USA Clinical Associate Professor of Medicine Wayne

More information

Show Me the Outcomes!

Show Me the Outcomes! Show Me the Outcomes! Real-World Safety Data on Oral Anticoagulants in Nonvalvular Atrial Fibrillation Gabby Anderson, PharmD PGY1 Pharmacy Resident anderson.gabrielle@mayo.edu Pharmacy Grand Rounds October

More information

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES. A. Prescriptions That Require Prior Authorization

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES. A. Prescriptions That Require Prior Authorization MEDICAL ASSISTANCE HBOOK PRI AUTHIZATION OF PHARMACEUTICAL SERVICES I. Requirements for Prior Authorization of Anticoagulants A. Prescriptions That Require Prior Authorization Prescriptions for Anticoagulants

More information

Afib, Stroke, and DOAC. Albert Luo, MD. Cardiology Lindsey Frischmann, DO. Neurology Xiao Cai, MD. HBS

Afib, Stroke, and DOAC. Albert Luo, MD. Cardiology Lindsey Frischmann, DO. Neurology Xiao Cai, MD. HBS Afib, Stroke, and DOAC Albert Luo, MD. Cardiology Lindsey Frischmann, DO. Neurology Xiao Cai, MD. HBS Disclosure of Relevant Financial Relationships I have no relevant financial relationships with commercial

More information

2 Summary of NICE TA 249: Atrial fibrillation - Dabigatran Etexilate

2 Summary of NICE TA 249: Atrial fibrillation - Dabigatran Etexilate Service Notification in response to DHSSPS endorsed NICE Technology Appraisals NICE TA 249: Atrial fibrillation - Dabigatran Etexilate 1 Name of Commissioning Team Long Term Conditions Commissioning Team

More information

3/19/2012. What is the indication for anticoagulation? Has the patient previously been on warfarin? If so, what % of the time was the INR therapeutic?

3/19/2012. What is the indication for anticoagulation? Has the patient previously been on warfarin? If so, what % of the time was the INR therapeutic? Abigail E. Miller, PharmD, BCPS Clinical Specialist, Cardiology University of North Carolina Hospitals I have no personal financial relationships with the manufacturers of the products to disclose. Boehringer

More information

NeuroPI Case Study: Anticoagulant Therapy

NeuroPI Case Study: Anticoagulant Therapy Case: An 82-year-old man presents to the hospital following a transient episode of left visual field changes. His symptoms lasted 20 minutes and resolved spontaneously. He has a normal neurological examination

More information

TSHP 2014 Annual Seminar 1

TSHP 2014 Annual Seminar 1 Debate: Versus the Rest of the World for Stroke Prevention in Non-valvular Atrial Fibrillation Matthew Wanat, PharmD, BCPS Clinical Assistant Professor University of Houston College of Pharmacy Clinical

More information

Edoxaban in Atrial Fibrillation

Edoxaban in Atrial Fibrillation Edoxaban in Atrial Fibrillation Glenn Gormley, MD, PhD Senior Executive Officer and Global Head of R&D, Daiichi Sankyo Co., Ltd Nov. 4, 2014 Tuesday Background Based on the results of ENGAGE AF-TIMI 48,

More information

Lessons from recent antithrombotic studies and trials in atrial fibrillation

Lessons from recent antithrombotic studies and trials in atrial fibrillation Lessons from recent antithrombotic studies and trials in atrial fibrillation Thromboembolism cause of stroke in AF Lars Wallentin Uppsala Clinical Research Centre (UCR) Uppsala Disclosures for Lars Wallentin

More information

ATRIAL FIBRILLATION: REVISITING CONTROVERSIES IN AN ERA OF INNOVATION

ATRIAL FIBRILLATION: REVISITING CONTROVERSIES IN AN ERA OF INNOVATION ATRIAL FIBRILLATION: REVISITING CONTROVERSIES IN AN ERA OF INNOVATION Frederick Schaller, DO, MACOI,FACP Adjunct Clinical Professor Touro University Nevada DISCLOSURES I have no financial relationships

More information

FACTOR Xa AND PAR-1 BLOCKER : ATLAS-2, APPRAISE-2 & TRACER TRIALS

FACTOR Xa AND PAR-1 BLOCKER : ATLAS-2, APPRAISE-2 & TRACER TRIALS New Horizons In Atherothrombosis Treatment 2012 순환기춘계학술대회 FACTOR Xa AND PAR-1 BLOCKER : ATLAS-2, APPRAISE-2 & TRACER TRIALS Division of Cardiology, Jeonbuk National University Medical School Jei Keon Chae,

More information

New Oral Anticoagulants

New Oral Anticoagulants New Oral Anticoagulants Tracy Minichiello, MD Associate Professor of Medicine Chief, San FranciscoVA Anticoagulation and Thrombosis Services What percentage of time do patients on warfarin spend in therapeutic

More information

INR as a Biomarker: Anticoagulation in Atrial Fib, Heart Failure, and Cardiovascular Disease Daniel Blanchard, MD, FACC, FAHA

INR as a Biomarker: Anticoagulation in Atrial Fib, Heart Failure, and Cardiovascular Disease Daniel Blanchard, MD, FACC, FAHA INR as a Biomarker: Anticoagulation in Atrial Fib, Heart Failure, and Cardiovascular Disease Daniel Blanchard, MD, FACC, FAHA Professor of Medicine Director, Cardiology Fellowship Program Sulpizio Cardiovascular

More information

Old and New Anticoagulants For Stroke Prevention Benefits and Risks

Old and New Anticoagulants For Stroke Prevention Benefits and Risks Old and New Anticoagulants For Stroke Prevention Benefits and Risks September 15, 2014 Jonathan L. Halperin, M.D. The Cardiovascular Institute Mount Sinai Medical Center Disclosure Relationships with Industry

More information

Newer Anti-Anginal Agents and Anticoagulants

Newer Anti-Anginal Agents and Anticoagulants Newer Anti-Anginal Agents and Anticoagulants Satish Gadi, MD FACC FSCAI Interventional Cardiologist, Cardiovascular Institute of the South (CIS) Baton Rouge Clinical Assistant Professor, Tulane University

More information

MODULE 1: Stroke Prevention in Atrial Fibrillation Benjamin Bell, MD, FRCPC

MODULE 1: Stroke Prevention in Atrial Fibrillation Benjamin Bell, MD, FRCPC MODULE 1: Stroke Prevention in Atrial Fibrillation Benjamin Bell, MD, FRCPC Specialty: General Internal Medicine Lecturer, Department of Medicine University of Toronto Staff Physician, General Internal

More information

Σεμινάπιο Ομάδων Δπγαζίαρ ΟΜΑΓΑ ΔΡΓΑΣΙΑΣ ΗΛΔΚΤΡΟΦΥΣΙΟΛΟΓΙΑΣ ΚΑΙ ΒΗΜΑΤΟΓΟΤΗΣΗΣ Κολπική μαπμαπςγή

Σεμινάπιο Ομάδων Δπγαζίαρ ΟΜΑΓΑ ΔΡΓΑΣΙΑΣ ΗΛΔΚΤΡΟΦΥΣΙΟΛΟΓΙΑΣ ΚΑΙ ΒΗΜΑΤΟΓΟΤΗΣΗΣ Κολπική μαπμαπςγή Σεμινάπιο Ομάδων Δπγαζίαρ ΟΜΑΓΑ ΔΡΓΑΣΙΑΣ ΗΛΔΚΤΡΟΦΥΣΙΟΛΟΓΙΑΣ ΚΑΙ ΒΗΜΑΤΟΓΟΤΗΣΗΣ Κολπική μαπμαπςγή Δξελίξειρ ζηην ανηιπηκηική αγωγή ζε αζθενείρ με κολπική μαπμαπςγή Ξςδώναρ Σωηήπιορ Μονάδα Δμθπαγμάηων και

More information

New options in Stroke Prevention in AF Paul Dorian University of Toronto St Michael s Hospital

New options in Stroke Prevention in AF Paul Dorian University of Toronto St Michael s Hospital New options in Stroke Prevention in AF Paul Dorian University of Toronto St Michael s Hospital Disclosures: Honoraria, research support, and consulting f Sanofi, Boehringer-Ingleheim, Portola, BMS, Bayer,

More information

NEW/NOVEL ORAL ANTICOAGULANTS (NOACS): COMPARISON AND FREQUENTLY ASKED QUESTIONS

NEW/NOVEL ORAL ANTICOAGULANTS (NOACS): COMPARISON AND FREQUENTLY ASKED QUESTIONS NEW/NOVEL ORAL ANTICOAGULANTS (NOACS): COMPARISON AND FREQUENTLY ASKED QUESTIONS OBJECTIVES: To provide a comparison of the new/novel oral anticoagulants (NOACs) currently available in Canada. To address

More information

NUOVI ANTICOAGULANTI NELL ANZIANO: indicazioni e controindicazioni. Mario Cavazza Medicina d Urgenza Pronto Soccorso AOU di Bologna

NUOVI ANTICOAGULANTI NELL ANZIANO: indicazioni e controindicazioni. Mario Cavazza Medicina d Urgenza Pronto Soccorso AOU di Bologna NUOVI ANTICOAGULANTI NELL ANZIANO: indicazioni e controindicazioni Mario Cavazza Medicina d Urgenza Pronto Soccorso AOU di Bologna Two major concerns Atrial Fibrillation: Epidemiology The No. 1 preventable

More information

Comparison of novel oral anticoagulants (NOACs)

Comparison of novel oral anticoagulants (NOACs) Comparison of novel oral anticoagulants (NOACs) For guidance for full information refer to individual SPCs available at www.medicines.org.uk Licensed indications for NOACs Prevention of stroke and systemic

More information

Atrial Fibrillation Topics for Today. Clinical Controversies Management of Atrial Fibrillation. Atrial Fibrillation in the ER Topics for Today

Atrial Fibrillation Topics for Today. Clinical Controversies Management of Atrial Fibrillation. Atrial Fibrillation in the ER Topics for Today Clinical Controversies Management of Atrial Fibrillation Yerem Yeghiazarians, M.D. Associate Professor of Medicine Leone-Perkins Family Endowed Chair in Cardiology Atrial Fibrillation Topics for Today

More information

Anticoagulation Task Force

Anticoagulation Task Force Anticoagulation Task Force Newest Recommendations Donald Zabriskie, BPharm, MBA, RPh Pharmacy Patient Care Services Cleveland Clinic- Fairview Hospital THE DRUGS THE PERFECT ANTICOAGULANT Oral administration

More information

Stroke Prophylaxis in AFib. Anil K. Gehi, MD Associate Professor of Medicine

Stroke Prophylaxis in AFib. Anil K. Gehi, MD Associate Professor of Medicine Stroke Prophylaxis in AFib Anil K. Gehi, MD Associate Professor of Medicine Case #1 72 year-old woman with high blood pressure, osteoporosis, pacemaker Noted on routine pacemaker check to have atrial fibrillation

More information

Primary Care Atrial Fibrillation Update: Anticoagulation and Left Atrial Appendage Occlusion. Greg Francisco, MD, FACC

Primary Care Atrial Fibrillation Update: Anticoagulation and Left Atrial Appendage Occlusion. Greg Francisco, MD, FACC Primary Care Atrial Fibrillation Update: Anticoagulation and Left Atrial Appendage Occlusion Greg Francisco, MD, FACC DISCLOSURES None to declare Estimated 33.5million have AF worldwide (6-7million in

More information

The INR: No Need Anymore? Daniel Blanchard, MD Professor of Medicine Director, Cardiology Fellowship Program UCSD Sulpizio Cardiovascular Center

The INR: No Need Anymore? Daniel Blanchard, MD Professor of Medicine Director, Cardiology Fellowship Program UCSD Sulpizio Cardiovascular Center The INR: No Need Anymore? Daniel Blanchard, MD Professor of Medicine Director, Cardiology Fellowship Program UCSD Sulpizio Cardiovascular Center What is the INR? Tissue Factor (Factor III) is added to

More information

Atrial Fibrillation and the NOAC s. John Raymond MS, PA-C, MHP February 10, 2018

Atrial Fibrillation and the NOAC s. John Raymond MS, PA-C, MHP February 10, 2018 Atrial Fibrillation and the NOAC s John Raymond MS, PA-C, MHP February 10, 2018 Pathogenesis EPIDEMIOLOGY Arrhythmia-related hospitalisations in the US Ventricular fibrillation 2% Atrial fibrillation 34%

More information

Xarelto (rivaroxaban)

Xarelto (rivaroxaban) Xarelto (rivaroxaban) Policy Number: 5.01.575 Last Review: 7/2018 Origination: 6/2014 Next Review: 7/2019 LoB: ACA Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Xarelto

More information

Stroke. 2012;43: ; originally published online August 2, 2012; doi: /STR.0b013e a

Stroke. 2012;43: ; originally published online August 2, 2012; doi: /STR.0b013e a Oral Antithrombotic Agents for the Prevention of Stroke in Nonvalvular Atrial Fibrillation : A Science Advisory for Healthcare Professionals From the American Heart Association/American Stroke Association

More information

Eliquis effect on inr prolongation 2017

Eliquis effect on inr prolongation 2017 Eliquis effect on inr prolongation 2017 The Borg System is 100 % Eliquis effect on inr prolongation 2017 Dec 17, 2016. Clin Chem Lab Med 2017; 55(8): e178 e180. Letter to the Editor. Tuukka A. Helin. prolongs

More information

ANTI-THROMBOTIC THERAPY in NON-VALVULAR ATRIAL FIBRILLATION

ANTI-THROMBOTIC THERAPY in NON-VALVULAR ATRIAL FIBRILLATION ANTI-THROMBOTIC THERAPY in NON-VALVULAR ATRIAL FIBRILLATION Colin Edwards Auckland Heart Group Waitemata Health June 2015 PFIZER Lecture series Disclosures EPIDEMIOLOGY Atrial fibrillation is the most

More information

Global Anticoagulants Market: Size, Trends & Forecasts ( ) April 2017

Global Anticoagulants Market: Size, Trends & Forecasts ( ) April 2017 Global Anticoagulants Market: Size, Trends & Forecasts (2017-2021) April 2017 Global Anticoagulants Market Scope of the Report The report entitled Global Anticoagulants Market: Size, Trends & Forecasts

More information

Role of NOACs in AF Management. From Evidence to Real World Data Focus on Cardioversion

Role of NOACs in AF Management. From Evidence to Real World Data Focus on Cardioversion Role of NOACs in AF Management. From Evidence to Real World Data Focus on Cardioversion John Rickard MD, MPH Staff Electrophysiologist Cleveland Clinic Agenda NOACs: Update on Real World Data NOAC reversal:

More information

Alison Tennant MRPharmS MPH Head of Service Improvement and Quality Dudley CCG

Alison Tennant MRPharmS MPH Head of Service Improvement and Quality Dudley CCG Alison Tennant MRPharmS MPH Head of Service Improvement and Quality Dudley CCG Commissioning is the set of linked activities required to assess the healthcare needs of a population, specify the services

More information

Observations from Novel Oral Anticoagulant (NOAC) Trials for Stroke Prevention in Atrial Fibrillation (SPAF)

Observations from Novel Oral Anticoagulant (NOAC) Trials for Stroke Prevention in Atrial Fibrillation (SPAF) Observations from Novel Oral Anticoagulant (NOAC) Trials for Stroke Prevention in Atrial Fibrillation (SPAF) CSRC NOAC Dosing Workshop December 3 rd, 2015 Jeffry Florian, Ph.D. Team Leader, Division of

More information

Drug Class Review Newer Oral Anticoagulant Drugs

Drug Class Review Newer Oral Anticoagulant Drugs Drug Class Review Newer Oral Anticoagulant Drugs Final Original Report May 2016 The purpose of reports is to make available information regarding the comparative clinical effectiveness and harms of different

More information

Indications of Anticoagulants; Which Agent to Use for Your Patient? Marc Carrier MD MSc FRCPC Thrombosis Program Ottawa Hospital Research Institute

Indications of Anticoagulants; Which Agent to Use for Your Patient? Marc Carrier MD MSc FRCPC Thrombosis Program Ottawa Hospital Research Institute Indications of Anticoagulants; Which Agent to Use for Your Patient? Marc Carrier MD MSc FRCPC Thrombosis Program Ottawa Hospital Research Institute Disclosures Research Support/P.I. Employee Leo Pharma

More information

NOAs for stroke prevention in Atrial Fibrillation: potential advantages in the elderly patients. Giancarlo Agnelli

NOAs for stroke prevention in Atrial Fibrillation: potential advantages in the elderly patients. Giancarlo Agnelli NOAs for stroke prevention in Atrial Fibrillation: potential advantages in the elderly patients Giancarlo Agnelli Internal & Cardiovascular Medicine - Stroke Unit University of Perugia, Italy My talk today

More information

Atrial Fibrillation in the Emergency Department

Atrial Fibrillation in the Emergency Department Atrial Fibrillation in the Emergency Department Disclosures Edward Jauch, MD MS Research support National Institutes of Health funding (multiple trials) Novo Nordisk (drug in kind) STOP-IT Study Genentech

More information

Peer Review Report #2. Novel oral anticoagulants. (1) Does the application adequately address the issue of the public health need for the medicine?

Peer Review Report #2. Novel oral anticoagulants. (1) Does the application adequately address the issue of the public health need for the medicine? 20 th Expert Committee on Selection and Use of Essential Medicines Peer Review Report #2 vel oral anticoagulants (1) Does the application adequately address the issue of the public health need for the

More information

New Antithrombotic Agents DISCLOSURE

New Antithrombotic Agents DISCLOSURE New Antithrombotic Agents DISCLOSURE Relevant Financial Relationship(s) Speaker Bureau None Research Alexion (PNH) delought@ohsu.edu Tom DeLoughery, MD FACP FAWM Oregon Health and Sciences University What

More information

Anti-thromboticthrombotic drugs

Anti-thromboticthrombotic drugs Atrial Fibrillation 2011: Anticoagulation strategies and clinical outcomes Panos E. Vardas President Elect of the ESC, Prof. of Cardiology, University Hospital of Crete Clinical outcomes affected by AF

More information

Dr Julia Hopyan Stroke Neurologist Sunnybrook Health Sciences Centre

Dr Julia Hopyan Stroke Neurologist Sunnybrook Health Sciences Centre Dr Julia Hopyan Stroke Neurologist Sunnybrook Health Sciences Centre Objectives To learn what s new in stroke care 2010-11 1) Acute stroke management Carotid artery stenting versus surgery for symptomatic

More information

Do s and Don t of DOACs DISCLOSURE

Do s and Don t of DOACs DISCLOSURE Do s and Don t of DOACs Tom DeLoughery, MD MACP FAWM Oregon Health and Sciences University DISCLOSURE Relevant Financial Relationship(s) Speaker Bureau - None Consultant/Research none Content Expert: Elsevier

More information

New Age Anticoagulants: Bleeding Considerations

New Age Anticoagulants: Bleeding Considerations Ontario Regional Blood Coordinating Network March 23, 2012 New Age Anticoagulants: Bleeding Considerations Bill Geerts, MD, FRCPC Thromboembolism Specialist, Sunnybrook HSC Professor of Medicine, University

More information

Apixaban for Atrial Fibrillation in Patients with End-Stage Renal Disease on Dialysis

Apixaban for Atrial Fibrillation in Patients with End-Stage Renal Disease on Dialysis Apixaban for Atrial Fibrillation in Patients with End-Stage Renal Disease on Dialysis Caitlin Reedholm, PharmD PGY1 Pharmacy Resident St. David s South Austin Medical Center November 2, 2018 Abbreviations

More information

Appendix C Factors to consider when choosing between anticoagulant options and FAQs

Appendix C Factors to consider when choosing between anticoagulant options and FAQs Appendix C Factors to consider when choosing between anticoagulant options and FAQs Choice of anticoagulant for non-valvular* atrial fibrillation: Clinical decision aid Patients should already be screened

More information

Technology appraisal guidance Published: 23 May 2012 nice.org.uk/guidance/ta256

Technology appraisal guidance Published: 23 May 2012 nice.org.uk/guidance/ta256 Rivaroxaban for the prevention ention of stroke and systemic embolism in people with atrial fibrillation Technology appraisal guidance Published: 23 May 2012 nice.org.uk/guidance/ta256 NICE 2018. All rights

More information

Let s Gi e The So ethi g To Clot About: Controversies in Anticoagulation

Let s Gi e The So ethi g To Clot About: Controversies in Anticoagulation Let s Gi e The So ethi g To Clot About: Controversies in Anticoagulation Janna Beavers, MS, PharmD, BCPS Cardiology Clinical Pharmacy Specialist WakeMed Health & Hospitals Raleigh, NC March 13, 2018 Pharmacist

More information

Apixaban versus Heparin/Vitamin K Antagonist in Anticoagulation-naïve Patients with Atrial Fibrillation Scheduled for Cardioversion: The EMANATE Trial

Apixaban versus Heparin/Vitamin K Antagonist in Anticoagulation-naïve Patients with Atrial Fibrillation Scheduled for Cardioversion: The EMANATE Trial Apixaban versus Heparin/Vitamin K Antagonist in Anticoagulation-naïve Patients with Atrial Fibrillation Scheduled for Cardioversion: The EMANATE Trial Michael D. Ezekowitz, Professor, Sidney Kimmel Medical

More information

Preventing Stroke in Patients with Atrial Fibrillation: USING THE EVIDENCE

Preventing Stroke in Patients with Atrial Fibrillation: USING THE EVIDENCE Preventing Stroke in Patients with Atrial Fibrillation: USING THE EVIDENCE What Is Atrial Fibrillation? Atrial fibrillation also called AFib or AF is the most common abnormal heart rhythm, affecting an

More information

Novel Anticoagulants PHYSICIANS UPDATE 2014

Novel Anticoagulants PHYSICIANS UPDATE 2014 Novel Anticoagulants PHYSICIANS UPDATE 2014 Farouk Mookadam MD FRCPC FACC MSc Professor College of Medicine Mayo Consultant Cardiovascular Diseases Medical Director Anticoagulation Clinic Assoc Programme

More information

HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) DABIGATRAN RECOMMENDED What it is Indications Date decision last revised

HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) DABIGATRAN RECOMMENDED What it is Indications Date decision last revised Name: generic (trade) Dabigatran etexilate (Pradaxa ) HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) DABIGATRAN RECOMMENDED What it is Indications Date decision last revised Direct thrombin inhibitor

More information

Results from RE-COVER RE-COVER II RE-MEDY RE-SONATE EXECUTIVE SUMMARY

Results from RE-COVER RE-COVER II RE-MEDY RE-SONATE EXECUTIVE SUMMARY Assessment of the safety and efficacy of dabigatran etexilate (Pradaxa ) in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE Results from

More information

Updates in Stroke Management. Jessica A Starr, PharmD, FCCP, BCPS Associate Clinical Professor Auburn University Harrison School of Pharmacy

Updates in Stroke Management. Jessica A Starr, PharmD, FCCP, BCPS Associate Clinical Professor Auburn University Harrison School of Pharmacy Updates in Stroke Management Jessica A Starr, PharmD, FCCP, BCPS Associate Clinical Professor Auburn University Harrison School of Pharmacy Disclosure I have no actual or potential conflict of interest

More information

New oral factor Xa inhibitors. Lessons from AVERROES and ARISTOTLE trials

New oral factor Xa inhibitors. Lessons from AVERROES and ARISTOTLE trials New oral factor Xa inhibitors. Lessons from AVERROES and ARISTOTLE trials Dimitri Richter, MD, FESC, FAHA Head of Cardiac Dept., Athens Euroclinic General Secretary of Hellenic Lipidology Society Member

More information

NOACS/DOACS*: COAGULATION TESTS

NOACS/DOACS*: COAGULATION TESTS NOACS/DOACS*: COAGULATION TESTS OBJECTIVES: To describe the effect of the newer direct oral anticoagulants (DOACs) on laboratory coagulation tests which are widely available: prothrombin time (PT), international

More information

Thrombosis and Thromboembolsim October Stroke Prevention in Atrial Fibrillation Risk Stratification and Choice of Antithrombotic Therapy

Thrombosis and Thromboembolsim October Stroke Prevention in Atrial Fibrillation Risk Stratification and Choice of Antithrombotic Therapy Thrombosis and Thromboembolsim October 2012 Stroke Prevention in Atrial Fibrillation Risk Stratification and Choice of Antithrombotic Therapy Christian T. Ruff, MD, MPH TIMI Study Group Brigham and Women

More information

ESC Stockholm Arrhythmias & pacing

ESC Stockholm Arrhythmias & pacing ESC Stockholm 2010 Take Home Messages for Practitioners Arrhythmias & pacing Prof. Panos E. Vardas Professor of Cardiology Heraklion University Hospital Crete, Greece Disclosures Small teaching fees from

More information

NOACs in AF. Dr Fiona Stewart. Auckland Heart Group and Auckland DHB

NOACs in AF. Dr Fiona Stewart. Auckland Heart Group and Auckland DHB NOACs in AF Dr Fiona Stewart Auckland Heart Group and Auckland DHB NOACS for AF True/False All patients should have a CHA 2 DS 2 VASc risk assessment on diagnosis of AF NOACS are more effective than warfarin

More information

Technology appraisal guidance Published: 15 March 2012 nice.org.uk/guidance/ta249

Technology appraisal guidance Published: 15 March 2012 nice.org.uk/guidance/ta249 Dabigatran an etexilate for the preventionention of stroke and systemic embolism in atrial fibrillation Technology appraisal guidance Published: 15 March 2012 nice.org.uk/guidance/ta249 NICE 2012. All

More information

Drug Class Monograph

Drug Class Monograph Drug Class Monograph Class: Oral Anticoagulants Drug: Coumadin (warfarin), Eliquis (apixaban), Pradaxa (dabigatran), Savaysa (edoxaban), arelto (rivaroxaban) Formulary Medications: Eliquis (apixaban),

More information

Anticoagulation: Novel Agents

Anticoagulation: Novel Agents Anticoagulation: Novel Agents Scott C. Woller, MD Medical Director, Anticoagulation Management, Intermountain Healthcare Central Region, co-director Venous Thromboembolism Program, Intermountain Medical

More information