Unstable INR Has Implications for Healthcare Resource Use. Janssen Pharmaceuticals, Inc.

Size: px
Start display at page:

Download "Unstable INR Has Implications for Healthcare Resource Use. Janssen Pharmaceuticals, Inc."

Transcription

1 Unstable INR Has Implications for Healthcare Resource Use Janssen Pharmaceuticals, Inc.

2 Stable INR is essential for effective anticoagulation treatment Achieving a stable international normalized ratio (INR), defined as an INR of 2.0 to 3.0, is a critical aspect of anticoagulation therapy. A patient s INR informs the dosage of warfarin, which has to be adjusted as the patient s INR changes. 1 Patients given warfarin can be complex to manage because INR stability is challenging to achieve. A patient s diet, lifestyle, concomitant medication use, and adherence to warfarin and other medications taken at the same time all have the potential to cause fluctuations in INR. 1,2 A meta-analysis of 95 studies of patients with atrial fibrillation (AF) found that patients spent an average of 56% of their time in therapeutic INR range. 3 In another analysis of 53 studies, patients with venous thromboembolism (VTE) spent 61% of their time out of range. 4 INR fluctuations have implications for health outcomes, resource use, and costs. In patients with AF, INR instability is a predictor of ischemic stroke and major bleeding. 3,5 In patients who have experienced VTE, lack of INR control is associated with VTE recurrence and hemorrhage. 4 INR instability also has been linked to higher risk of major bleeding, fatal bleeding, and ischemic stroke. 6

3 The difficulty of achieving stable INR The challenges associated with INR management were illustrated in a large retrospective study of a national anticoagulation management service database. 7 Among more than 15,000 patients initiated on warfarin...* 7 Instability: by the numbers Even after achieving stabilization, fluctuation of INR values above or below therapeutic range of 2.0 to 3.0 for the duration of the study was common. 7 Moreover, stabilization was a predictor of persistence with warfarin therapy. Not achieving stabilization was associated with discontinuation of therapy within 4 months. Patients whose INR was stabilized within 1 year were 10 times more likely to remain on warfarin therapy than those whose INR was not. 7 The average time required to stabilize INR in patients taking warfarin 7 Increase in likelihood of remaining on warfarin therapy when INR was stabilized within 1 year 7 Share of patients who never achieved INR stability 7 Share of patients with INR above or below therapeutic range after stabilization 7

4 Implications for healthcare resource use For payers, INR instability has substantial clinical and cost implications. For example, a large integrated health system examined records of more than 6000 patients prescribed warfarin. Patients whose INR was not stabilized over 6 months had more than a fivefold increase in the risk of death than those who achieved INR values within the defined therapeutic range. Anticoagulation-related bleeding events or thrombosis were over 4 times more prevalent in the unstable cohort. 6 Other studies have examined the resource use and economic effects associated with the difficulties of warfarin management: The challenges of warfarin use may be underestimated. In patients with AF and VTE, INR instability has implications for healthcare resource use and costs. Emergency hospitalizations related to adverse drug events involving warfarin 8 A concomitant medication was implicated in 12.5% of hospitalizations attributed to warfarin 8 Incremental cost of treating hemorrhagic events in patients who used warfarin-potentiating medication 9

5 * Nelson study design: Patients anticoagulation management records from 2006 to 2010 were collected by decision support software. Adult patients with nonvalvular AF who had at least 3 INR values in the dataset were followed from warfarin initiation to the first 90-day gap in anticoagulation clinic visits or end of the data time frame. In total, 15,276 patients (55% male) met inclusion criteria. Mean follow-up time was 15 months. Mean ages of those achieving and not achieving INR stabilization were 72.4 and 70.7 years, respectively. Stabilization was defined as having 3 consecutive INR values between 2.0 and 3.0 after warfarin initiation. 7 Witt study design: Retrospective longitudinal cohort study. Inclusion criteria were duration of warfarin therapy >90 days, at least 1 INR determination during the study time frame ( ), age >18 years, and warfarin therapy continuing throughout a 6-month observation period. Stability was defined as having all INR values within the strictly defined therapeutic reference interval for the first identifiable continuous 6-month period. 6 Budnitz study design: Adverse-event data from the National Electronic Injury Surveillance System Cooperative Adverse Drug Event Surveillance project was used to estimate the frequency and rates of hospitalizations after emergency department visits for adverse drug events in patients aged 65 from 2007 through Suh study design: A nested-case control study of long-term warfarin-treated AF patients 18 years old using the Medstat MarketScan database of health insurance claims from 2004 to Patients with a hemorrhagic event were matched to control patients. Treatment costs were calculated during the 3-month time frame after the occurrence of the hemorrhagic event. Hemorrhage-related costs were costs associated with medical services involved in hemorrhagic treatment and prescription drug costs for hemostatic agents. 9 Study Designs

6 References 1. Hirsh J, Fuster V, Ansell J, Halperin JL. American Heart Association/American College of Cardiology Foundation guide to warfarin therapy. Circulation. 2003;107: Eikelboom JW, Hart RG. Antithrombotic therapy for stroke prevention in atrial fibrillation and mechanical heart valves. Am J Hematol. 2012;87(S1): Mearns ES, White CM, Kohn CG, et al. Quality of vitamin K antagonist control and outcomes in atrial fibrillation patients: a meta-analysis and meta-regression. Thromb J. 2014;12:14. doi: / Mearns ES, Kohn CG, Song JS, et al. Meta-analysis to assess the quality of international normalized ratio control and associated outcomes in venous thromboembolism patients. Thromb Res. 2014;134: Razouki Z, Ozonoff A, Zhao S, et al. Improving quality measurement for anticoagulation: adding international normalized ratio variability to percent time in therapeutic range. Circ Cardiovasc Qual Outcomes. 2014;7: Witt DM, Delate T, Clark NP, et al. Outcomes and predictors of very stable INR control during chronic anticoagulation therapy. Blood. 2009:114: Nelson WW, Desai S, Damaraju CV, et al. International normalized ratio stabilization in newly initiated warfarin patients with nonvalvular atrial fibrillation. Curr Med Res Opin. 2014: Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365: Suh D-C, Nelson WW, Choi JC, Choi I. Risk of hemorrhage and treatment costs associated with warfarin drug interactions in patients with atrial fibrillation. Clin Ther. 2012;34: Sebastian Ferreira, Untitled Artwork from the National Art Exhibitions of the Mentally Ill, Inc. (NAEMI) Janssen Pharmaceuticals, Inc Route 202 Raritan, NJ Janssen Pharmaceuticals, Inc December

The New Drugs: Are They Worth It? A PHARMACOECONOMIC PERSPECTIVE

The New Drugs: Are They Worth It? A PHARMACOECONOMIC PERSPECTIVE The New Drugs: Are They Worth It? A PHARMACOECONOMIC PERSPECTIVE Niteesh K. Choudhry, MD, PhD Associate Professor, Harvard Medical School Associate Physician, Division of Pharmacoepidemiology and Pharmacoeconomics,

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

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

Title: Should oral anticoagulant therapy be continued during dental extraction? A meta-analysis

Title: Should oral anticoagulant therapy be continued during dental extraction? A meta-analysis Author s response to reviews Title: Should oral anticoagulant therapy be continued during dental extraction? A meta-analysis Authors: Shuo Yang (sophiasure@163.com) Quan Shi (shiquan3333@sina.cn) Jinglong

More information

Antithrombotic Therapy in Patients with Atrial Fibrillation

Antithrombotic Therapy in Patients with Atrial Fibrillation Antithrombotic Therapy in Patients with Atrial Fibrillation June Soo Kim, M.D., Ph.D. Department of Medicine Cardiac & Vascular Center, Samsung Medical Center Sungkyunkwan University School of Medicine

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

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

Chapter 1 Introduction

Chapter 1 Introduction Chapter 1 Introduction There are several disorders which carry an increased risk of thrombosis, clots that interfere with normal circulation, including: venous thromboembolism (VTE), comprising both deep

More information

Evaluate Risk of Stroke & Bleeding in AF Patients

Evaluate Risk of Stroke & Bleeding in AF Patients XV World Congress of Arrhythmias, Beijing, China - 17-20 September, 2015 Evaluate Risk of Stroke & Bleeding in AF Patients Antonio Raviele, MD, FESC, FHRS President ALFA Alliance to Fight Atrial fibrillation

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

Practical Considerations for Using Oral Anticoagulants in Patients with Chronic Kidney Disease

Practical Considerations for Using Oral Anticoagulants in Patients with Chronic Kidney Disease Practical Considerations for Using Oral Anticoagulants in Patients with Chronic Kidney Disease Cyrille K. Cornelio, Pharm.D. PGY2 Cardiology Pharmacy Resident The University of Oklahoma College of Pharmacy

More information

Determinants of effective, safe and convenient vitamin K antagonist use Kooistra, Hilde Afra Margaretha

Determinants of effective, safe and convenient vitamin K antagonist use Kooistra, Hilde Afra Margaretha University of Groningen Determinants of effective, safe and convenient vitamin K antagonist use Kooistra, Hilde Afra Margaretha IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's

More information

A guide to anticoagulation management and self-testing

A guide to anticoagulation management and self-testing A guide to management and self-testing Understanding If you re reading this, you, or someone you care about, may be on oral therapy, usually treated with a vitamin K antagonist (VKA). VKAs, such as warfarin,

More information

New Data Reaffirm Positive Benefit-Risk Balance of Bayer s Xarelto in Patients with Atrial Fibrillation in Daily Clinical Practice

New Data Reaffirm Positive Benefit-Risk Balance of Bayer s Xarelto in Patients with Atrial Fibrillation in Daily Clinical Practice Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com 12 th Annual Congress of the European Cardiac Arrhythmia Society (ECAS) 2016:

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

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Stratificazione del rischio, corretto bilancio tra ischemia e bleeding: il beneficio clinico netto

Stratificazione del rischio, corretto bilancio tra ischemia e bleeding: il beneficio clinico netto Fibrillazione atriale: rischio tromboembolico, Venezia - 27/28 Novembre 2015 Stratificazione del rischio, corretto bilancio tra ischemia e bleeding: il beneficio clinico netto Antonio Raviele, MD, FESC,

More information

State of art in anticoagulation in non valvular Atrial Fibrillation: the additional value of Rivaroxaban real life data

State of art in anticoagulation in non valvular Atrial Fibrillation: the additional value of Rivaroxaban real life data State of art in anticoagulation in non valvular Atrial Fibrillation: the additional value of Rivaroxaban real life data Massimo Grimaldi Ospedale F. Miulli Acquaviva delle Fonti - Bari Disclosure Biosense

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

Jacqueline C. Barrientos, Nicole Meyer, Xue Song, Kanti R. Rai ASH Annual Meeting Abstracts 2015:3301

Jacqueline C. Barrientos, Nicole Meyer, Xue Song, Kanti R. Rai ASH Annual Meeting Abstracts 2015:3301 Characterization of atrial fibrillation and bleeding risk factors in patients with CLL: A population-based retrospective cohort study of administrative medical claims data in the U.S. Jacqueline C. Barrientos,

More information

ADC Slides for Presentation 02/10/2017

ADC Slides for Presentation 02/10/2017 ADC 2017 Slides for Presentation ANTI THROMBOTIC THERAPY FOR NON VALVULAR ATRIAL FIBRILLATION IN PATIENTS WITH CHRONIC KIDNEY DISEASE: CURRENT VIEWS Martin A. Alpert, MD Brent M. Parker Professor of Medicine

More information

Reducing the Risk of Stroke Associated With Nonvalvular Atrial Fibrillation in the VHA

Reducing the Risk of Stroke Associated With Nonvalvular Atrial Fibrillation in the VHA DECEMBER 21 VOL. 27 SUPPL. 1 A SUPPLEMENT TO www.fedprac.com Reducing the Risk of Stroke Associated With Nonvalvular Atrial Fibrillation in the VHA Diagnosing and Treating Atrial Fibrillation in the VHA

More information

Warfarin for Long-Term Anticoagulation. Disadvantages of Warfarin. Narrow Therapeutic Window. Warfarin vs. NOACs. Challenges Monitoring Warfarin

Warfarin for Long-Term Anticoagulation. Disadvantages of Warfarin. Narrow Therapeutic Window. Warfarin vs. NOACs. Challenges Monitoring Warfarin 1 2:15 pm The Era of : Selecting the Best Approach to Treatment SPEAKER Gregory Piazza, MD, MS Presenter Disclosure Information The following relationships exist related to this presentation: Gregory Piazza,

More information

MEDICAL POLICY SUBJECT: HOME PROTHROMBIN TIME MONITORING DEVICE. POLICY NUMBER: CATEGORY: Equipment/Supplies

MEDICAL POLICY SUBJECT: HOME PROTHROMBIN TIME MONITORING DEVICE. POLICY NUMBER: CATEGORY: Equipment/Supplies MEDICAL POLICY SUBJECT: HOME PROTHROMBIN TIME 06/23/16, 6/22/17 PAGE: 1 OF: 5 If a product excludes coverage for a service, it is not covered, and medical policy criteria do not apply. If a commercial

More information

Trends and Variation in Oral Anticoagulant Choice in Patients with Atrial Fibrillation,

Trends and Variation in Oral Anticoagulant Choice in Patients with Atrial Fibrillation, Trends and Variation in Oral Anticoagulant Choice in Patients with Atrial Fibrillation, 2010-2017 Junya Zhu, PhD Department of Health Policy and Management January 23, 2018 Acknowledgments Co-Authors G.

More information

US FDA Approves Pradaxa (dabigatran etexilate) a breakthrough treatment for stroke risk reduction in non-valvular atrial fibrillation

US FDA Approves Pradaxa (dabigatran etexilate) a breakthrough treatment for stroke risk reduction in non-valvular atrial fibrillation Press Release For non-us Healthcare Media Boehringer Ingelheim GmbH Corporate Communications US FDA Approves Pradaxa (dabigatran etexilate) a breakthrough treatment for stroke risk reduction in non-valvular

More information

Aspirin at the Intersection of Antiplatelet and Anticoagulant Therapy An Act of Commission?

Aspirin at the Intersection of Antiplatelet and Anticoagulant Therapy An Act of Commission? Aspirin at the Intersection of Antiplatelet and Anticoagulant Therapy An Act of Commission? Ty J. Gluckman, MD, FACC, FAHA Medical Director, Center for Cardiovascular Analytics, Research and Data Science

More information

Primary Care practice clinics within the Edmonton Southside Primary Care Network.

Primary Care practice clinics within the Edmonton Southside Primary Care Network. INR Monitoring and Warfarin Dose Adjustment Last Review: November 2016 Intervention(s) and/or Procedure: Registered Nurses (RNs) adjust warfarin dosage according to individual patient International Normalized

More information

DECLARATION OF CONFLICT OF INTEREST

DECLARATION OF CONFLICT OF INTEREST DECLARATION OF CONFLICT OF INTEREST Warfarin and the risk of major bleeding events in patients with atrial fibrillation: a population-based study Laurent Azoulay PhD 1,2, Sophie Dell Aniello MSc 1, Teresa

More information

Bleeding Complications in Patients Receiving Direct Oral Anticoagulant Therapy in the Post Clinical Trial General Practice

Bleeding Complications in Patients Receiving Direct Oral Anticoagulant Therapy in the Post Clinical Trial General Practice American Journal of Clinical and Experimental Medicine 2017; 5(3): 64-68 http://www.sciencepublishinggroup.com/j/ajcem doi: 10.11648/j.ajcem.20170503.12 ISSN: 2330-8125 (Print); ISSN: 2330-8133 (Online)

More information

Abstract. Introduction. imedpub Journals Doson Chua* Research Article. Cardiovascular Investigations: Open Access

Abstract. Introduction. imedpub Journals  Doson Chua* Research Article. Cardiovascular Investigations: Open Access Research Article imedpub Journals www.imedpub.com Cardiovascular Investigations: Open Access Vol. 2 No.1: 1 Use of Non-vitamin K Antagonist Oral Anticoagulants (NOAC) for Stroke Prevention in Patients

More information

RETROSPECTIVE CLAIMS DATABASE STUDIES OF DIRECT ORAL ANTICOAGULANTS (DOACS) FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION

RETROSPECTIVE CLAIMS DATABASE STUDIES OF DIRECT ORAL ANTICOAGULANTS (DOACS) FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION RETROSPECTIVE CLAIMS DATABASE STUDIES OF DIRECT ORAL ANTICOAGULANTS (DOACS) FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION Craig I. Coleman, PharmD Professor, University of Connecticut School

More information

Drug Use Criteria: Direct Oral Anticoagulants

Drug Use Criteria: Direct Oral Anticoagulants Texas Vendor Drug Program Drug Use Criteria: Oral Anticoagulants Publication History 1. Developed March 2017. 2. Revised February 2018. Notes: Information on indications for use or diagnosis is assumed

More information

American College of Cardiology 66th Annual Scientific Session (ACC.17):

American College of Cardiology 66th Annual Scientific Session (ACC.17): News Release Not intended for U.S. and UK Media Bayer AG Communications and Public Affairs 51368 Leverkusen Germany Tel. +49 214 30-0 www.news.bayer.com American College of Cardiology 66th Annual Scientific

More information

Atrial Fibrillation and Heart Failure: A Cause or a Consequence

Atrial Fibrillation and Heart Failure: A Cause or a Consequence Atrial Fibrillation and Heart Failure: A Cause or a Consequence Rajat Deo, MD, MTR Assistant Professor of Medicine Division of Cardiology, Electrophysiology Section University of Pennsylvania November

More information

Do Not Cite. Draft for Work Group Review.

Do Not Cite. Draft for Work Group Review. Defect Free Acute Inpatient Ischemic Stroke Measure Bundle Measure Description Percentage of patients aged 18 years and older with a diagnosis of ischemic stroke OR transient ischemic attack who were admitted

More information

NOAC vs. Warfarin in AF Catheter Ablation

NOAC vs. Warfarin in AF Catheter Ablation KHRS 2013 2013-Jun-15 NOAC vs. Warfarin in AF Catheter Ablation Jin-Seok Kim, MD Department of Cardiology Sejong General Hospital Bucheon, Republic of Korea Clinical Burden of AF Rhythm Disturbance Thromboembolic

More information

Study period Total sample size (% women) 899 (37.7%) Warfarin Aspirin

Study period Total sample size (% women) 899 (37.7%) Warfarin Aspirin Table S2 Sex- specific differences in oral anticoagulant prescription for stroke prevention in AF Total sample size (% women) Anticoagulant(s) studied Gage (2000) 1 Missouri, USA Discharged during 597

More information

Pradaxa (dabigatran)

Pradaxa (dabigatran) Pradaxa (dabigatran) Policy Number: 5.01.574 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 Pradaxa

More information

Direct oral anticoagulant use and the incidence of bleeding in the very elderly with atrial fibrillation

Direct oral anticoagulant use and the incidence of bleeding in the very elderly with atrial fibrillation J Thromb Thrombolysis (2016) 42:573 578 DOI 10.1007/s19-016-1410-z Direct oral anticoagulant use and the incidence of in the very elderly with atrial fibrillation Fatima Khan 1,2 Hans Huang 2 Yvonne H.

More information

Management of Anticoagulation during Device Implants; Coumadin to Novel Agents

Management of Anticoagulation during Device Implants; Coumadin to Novel Agents Management of Anticoagulation during Device Implants; Coumadin to Novel Agents DR D Birnie Invited Faculty Core Curriculum Heart Rhythm Society May 8 th 2014 Disclosures Boehringer Ingleheim Research Support

More information

Discuss the role of idarucizumab for the management of bleeding associated with dabigatran

Discuss the role of idarucizumab for the management of bleeding associated with dabigatran Discuss the role of idarucizumab for the management of bleeding associated with dabigatran Understand dosing, preparation and administration of idarucizumab I have no financial interest/arrangement or

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

Clinical and Economic Value of Rivaroxaban in Coronary Artery Disease

Clinical and Economic Value of Rivaroxaban in Coronary Artery Disease CHRISTOPHER B. GRANGER, MD Professor of Medicine Division of Cardiology, Department of Medicine; Director, Cardiac Care Unit Duke University Medical Center, Durham, NC Clinical and Economic Value of Rivaroxaban

More information

For more than 50 years, warfarin was the sole oral

For more than 50 years, warfarin was the sole oral Prescribing Patterns of Novel Anticoagulants Within a Statewide Multispecialty Practice At a Glance Practical Implications p 98 Author Information p 102 Full text and PDF www.ajpb.com Original Research

More information

CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION

CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION Edoxaban (Lixiana SERVIER Canada Inc.) Indication: Prevention of Stroke and Systemic Embolic Events in Patients With Nonvalvular Atrial Fibrillation

More information

Reversal Agents for NOACs (Novel Oral Anticoagulants)

Reversal Agents for NOACs (Novel Oral Anticoagulants) Reversal Agents for NOACs (Novel Oral Anticoagulants) Current status and future challenges Paul A Reilly, PhD Clinical Research, Boehringer Ingelheim, Inc CSRC Symposium Washington DC Oct 18, 2016 Atrial

More information

A Look at Patient Compliance to INR Testing and Therapeutic Range Management of Patients on Warfarin at Agassiz Medical Center.

A Look at Patient Compliance to INR Testing and Therapeutic Range Management of Patients on Warfarin at Agassiz Medical Center. A Look at Patient Compliance to INR Testing and Therapeutic Range Management of Patients on Warfarin at Agassiz Medical Center Lauren Martens Abstract This study sought to determine the total number of

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

Draft Agreed by Cardiovascular Working Party 25 Jan Adoption by CHMP for release for consultation 17 Feb 2011

Draft Agreed by Cardiovascular Working Party 25 Jan Adoption by CHMP for release for consultation 17 Feb 2011 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 London, 25 January 2011 EMA/CHMP/68875/2011 Committee for Medicinal Products for Human Use (CHMP) Concept paper on the need for a guideline on clinical investigation

More information

Complicanze aritmiche in riabilitazione dopo CCH.

Complicanze aritmiche in riabilitazione dopo CCH. Complicanze aritmiche in riabilitazione dopo CCH www.fisiokinesiterapia.biz Post-Operative Atrial Fibrillation The rate of AF after cardiac surgery in the 1970s was about 10%, and is now consistently at

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

PIONEER AF-PCI Study with Bayer s Xarelto Accepted as Late- Breaking Clinical Trial Presentation at AHA 2016

PIONEER AF-PCI Study with Bayer s Xarelto Accepted as Late- Breaking Clinical Trial Presentation at AHA 2016 News Release Not intended for U.S. and UK Media Bayer AG Communications, Government Relations & Corporate Brand 51368 Leverkusen Germany Tel. +49 214 30-0 www.news.bayer.com American Heart Association

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Single Technology Appraisal (STA)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Single Technology Appraisal (STA) Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation Thank you for agreeing to give us a statement on your organisation s view of the technology and the way

More information

Blood Day for Primary Care

Blood Day for Primary Care Blood Day for Primary Care including the Anticoagulation, use of novel oral anticoagulants in DVT/PE & atrial fibrillation Marc Carrier MD MSc. FRCPC Department of Internal Medicine, Division of Hematology,

More information

GLORIA -AF REGISTRY PROGRAMME

GLORIA -AF REGISTRY PROGRAMME GLORIA -AF REGISTRY PROGRAMME EXECUTIVE SUMMARY The approval of novel oral anticoagulants has changed prescribing patterns for stroke prevention in atrial fibrillation (AF) worldwide. 1 There is a need

More information

The Egyptian Journal of Hospital Medicine (Jan. 2016) Vol. 62, Page 89-94

The Egyptian Journal of Hospital Medicine (Jan. 2016) Vol. 62, Page 89-94 The Egyptian Journal of Hospital Medicine (Jan. 2016) Vol. 62, Page 89-94 An Audit Evaluating Anticoagulation Clinic Managed by Clinical Pharmacists in Jordan Nadia A. Al-Omari 1, Nairooz H. Al-Momany

More information

True/False: Idarucizumab can be utilized for the management of bleeding associated with dabigatran.

True/False: Idarucizumab can be utilized for the management of bleeding associated with dabigatran. Discuss the role of idarucizumab for the management of bleeding associated with dabigatran Understand dosing, preparation and administration of idarucizumab I have no financial interest/arrangement or

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

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

Real-world persistence and adherence to oral anticoagulation for stroke risk reduction in patients with atrial fibrillation

Real-world persistence and adherence to oral anticoagulation for stroke risk reduction in patients with atrial fibrillation Europace (2016) 18, 1150 1157 doi:10.1093/europace/euv421 CLINICAL RESEARCH Atrial fibrillation Real-world persistence and adherence to oral anticoagulation for stroke risk reduction in patients with atrial

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

Warfarin Management-Review

Warfarin Management-Review Warfarin Management-Review December 18, 2012 Elaine M. Hylek, MD, MPH Director, Thrombosis Clinic and Anticoagulation Service Boston University Medical Center Areas for Discussion Implications of time

More information

Objectives. Falling Down on Warfarin Therapy. CHADS 2 Score. CHADS 2 & CHA 2 DS 2 -VASc Score. HAS-BLED Score 04/08/2014. Real World Application

Objectives. Falling Down on Warfarin Therapy. CHADS 2 Score. CHADS 2 & CHA 2 DS 2 -VASc Score. HAS-BLED Score 04/08/2014. Real World Application Falling Down on Warfarin Therapy David Andrew Jacob, PharmD Pharmacy Resident 2013-2014 Dayton VA Medical Center Dayton, Ohio Objectives Describe CHADS 2 score and the decision to anticoagulate patients

More information

Bayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency

Bayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Bayer submits application for marketing approval of rivaroxaban for patients

More information

Direct Oral Anticoagulant Reversal

Direct Oral Anticoagulant Reversal 08 June 2018 No. 08 Direct Oral Anticoagulant Reversal M Khattab Moderator: E Hodgson School of Clinical Medicine Discipline of Anaesthesiology and Critical Care CONTENTS INTRODUCTION... 3 Pharmacokinetics

More information

2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY. MEASURE TYPE: Process

2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY. MEASURE TYPE: Process Quality ID #326 (NQF 1525): Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy National Quality Strategy Domain: Effective Clinical Care 2018 OPTIONS F INDIVIDUAL MEASURES: REGISTRY

More information

Dental Management Considerations for Patients on Antithrombotic Therapy

Dental Management Considerations for Patients on Antithrombotic Therapy Dental Management Considerations for Patients on Antithrombotic Therapy Warfarin and Antiplatelet Joel J. Napeñas DDS FDSRCS(Ed) Program Director General Practice Residency Program Department of Oral Medicine

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

Duration of Anticoagulant Therapy. Linda R. Kelly PharmD, PhC, CACP September 17, 2016

Duration of Anticoagulant Therapy. Linda R. Kelly PharmD, PhC, CACP September 17, 2016 Duration of Anticoagulant Therapy Linda R. Kelly PharmD, PhC, CACP September 17, 2016 Conflicts of Interest No conflicts of interest to report Objectives At the end of the program participants will be

More information

Update in Outpatient Medicine ACP Scientific Session November 12, 2016

Update in Outpatient Medicine ACP Scientific Session November 12, 2016 Update in Outpatient Medicine ACP Scientific Session November 12, 2016 Robert Gluckman MD, MACP Chief Medical Officer Providence Health Plans Disclosures Stock Holdings Abbott Labs Abbvie Bristol Myers

More information

Anticoagulation, atrial fibrillation in elderly patients with chronic kidney disease

Anticoagulation, atrial fibrillation in elderly patients with chronic kidney disease Anticoagulation, atrial fibrillation in elderly patients with chronic kidney disease Zbigniew Heleniak M.D. Ph.D. Department of Nephrology, Transplantology and Internal Medicine Medical University of Gdansk

More information

Controversies in Anticoagulation : Optimizing Outcome in NOACs for GI Bleeding Risk

Controversies in Anticoagulation : Optimizing Outcome in NOACs for GI Bleeding Risk Controversies in Anticoagulation : Optimizing Outcome in NOACs for GI Bleeding Risk Boyoung Joung, MD, PhD Professor, Division of Cardiology Director of Electrophysiology Laboratory Severance Cardiovascular

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

Updates in Anticoagulation for Atrial Fibrillation and Venous Thromboembolism

Updates in Anticoagulation for Atrial Fibrillation and Venous Thromboembolism Disclosures Updates in Anticoagulation for Atrial Fibrillation and Venous Thromboembolism No financial conflicts of interest Member of the ABIM Focused- Practice in Hospital Medicine Self Examination Process

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

The Poor Long-Term Candidate for Warfarin: NOAC or Left Atrial Appendage Closure?

The Poor Long-Term Candidate for Warfarin: NOAC or Left Atrial Appendage Closure? The Poor Long-Term Candidate for Warfarin: NOAC or Left Atrial Appendage Closure? Suneet Mittal, MD, FACC, FHRS Director, Electrophysiology Laboratory Valley Health System Ridgewood, NJ and New York, NY

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

ACC/AHA/Physician Consortium Clinical Performance Measures for Adults with Nonvalvular Atria Fibrillation or Atrial Flutter

ACC/AHA/Physician Consortium Clinical Performance Measures for Adults with Nonvalvular Atria Fibrillation or Atrial Flutter ACC/AHA/Physician Consortium Clinical Performance Measures for Adults with Nonvalvular Atria Fibrillation or Atrial Flutter A Report of the American College of Cardiology/American Heart Association Task

More information

APPENDIX A NORTH AMERICAN SYMPTOMATIC CAROTID ENDARTERECTOMY TRIAL

APPENDIX A NORTH AMERICAN SYMPTOMATIC CAROTID ENDARTERECTOMY TRIAL APPENDIX A Primary Findings From Selected Recent National Institute of Neurological Disorders and Stroke-Sponsored Clinical Trials That Have shaped Modern Stroke Prevention Philip B. Gorelick 178 NORTH

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

Clinical Practice Committee Anticoagulation Bridging Document

Clinical Practice Committee Anticoagulation Bridging Document Original: 10/23/06 Last Updated: 10/30/07 Clinical Practice Committee Do patients on long term oral anticoagulant therapy who require short term interruption of warfarin for an elective invasive procedure

More information

Management of Patients with Atrial Fibrillation Undergoing Coronary Artery Stenting 경북대의전원내과조용근

Management of Patients with Atrial Fibrillation Undergoing Coronary Artery Stenting 경북대의전원내과조용근 Management of Patients with Atrial Fibrillation Undergoing Coronary Artery Stenting 경북대의전원내과조용근 Case (2011, 5) 74-years old gentleman Exertional chest pain Warfarin with good INR control Ex-smoker, social(?)

More information

CADTH Therapeutic Review

CADTH Therapeutic Review Canadian Agency for Drugs and Technologies in Health Agence canadienne des médicaments et des technologies de la santé CADTH Therapeutic Review August 2012 Volume 1, Issue 1A Antithrombotic Therapy for

More information

Results from the ENSURE-AF study were presented during the ESC Congress 2016 Hot Line session and the full results are published in The Lancet

Results from the ENSURE-AF study were presented during the ESC Congress 2016 Hot Line session and the full results are published in The Lancet Press Release ENSURE-AF Data Support the Efficacy and Safety Profile of Daiichi Sankyo s Once-Daily LIXIANA in Patients with Atrial Fibrillation Undergoing Cardioversion ENSURE-AF is the largest clinical

More information

Effectiveness and Safety of Direct Oral Anticoagulants and Warfarin Among Patients with Sickle Cell Disease: A Retrospective Cohort Study

Effectiveness and Safety of Direct Oral Anticoagulants and Warfarin Among Patients with Sickle Cell Disease: A Retrospective Cohort Study Effectiveness and Safety of Direct Oral Anticoagulants and Warfarin Among Patients with Sickle Cell Disease: A Retrospective Cohort Study Megan Roberts, PharmD, BCPS MUSC Medical Center and South Carolina

More information

DOAC the story so far... Dr GM Benson Director NI Haemophilia and Thrombosis Centre BHSCT

DOAC the story so far... Dr GM Benson Director NI Haemophilia and Thrombosis Centre BHSCT DOAC the story so far... Dr GM Benson Director NI Haemophilia and Thrombosis Centre BHSCT A rose by any other name.. Recommendation on the nomenclature for oral anticoagulants: communication from the SSC

More information

New Oral Anticoagulants in treatment of VTE, PE DR.AMR HANAFY (LECTURER OF CARDIOLOGY ) ASWAN UNIVERSITY

New Oral Anticoagulants in treatment of VTE, PE DR.AMR HANAFY (LECTURER OF CARDIOLOGY ) ASWAN UNIVERSITY New Oral Anticoagulants in treatment of VTE, PE DR.AMR HANAFY (LECTURER OF CARDIOLOGY ) ASWAN UNIVERSITY Fact VTE is deadly! It nibbles after it bites! The 30-day mortality rates for first-time DVT or

More information

ADHERENCE TO INR MONITORING IN THE COMMUNITY AMONG VKA-TREATED PATIENTS IN SASKATCHEWAN : AN OBSERVATIONAL STUDY. A Thesis Submitted to the College of

ADHERENCE TO INR MONITORING IN THE COMMUNITY AMONG VKA-TREATED PATIENTS IN SASKATCHEWAN : AN OBSERVATIONAL STUDY. A Thesis Submitted to the College of ADHERENCE TO INR MONITORING IN THE COMMUNITY AMONG VKA-TREATED PATIENTS IN SASKATCHEWAN : AN OBSERVATIONAL STUDY A Thesis Submitted to the College of Graduate Studies and Research in Partial Fulfillment

More information

pat hways Key therapeutic topic Published: 26 February 2016 nice.org.uk/guidance/ktt16

pat hways Key therapeutic topic Published: 26 February 2016 nice.org.uk/guidance/ktt16 pat hways Anticoagulants, including non-vitamin K antagonist oral anticoagulants (NOACs) Key therapeutic topic Published: 26 February 2016 nice.org.uk/guidance/ktt16 Options for local implementation NICE

More information

NOAC s across indications

NOAC s across indications Sektion CAMPUS INNENSTADT Med. Klinik und Poliklinik IV NOAC s across indications Ulrich Hoffmann, M.D. Division of Vascular Medicine University Hospital Munich, Germany Disclosure Speaker name: Ulrich

More information

to a DOAC anticoagulants (DOACs) dosing of DOACs for various indications switching from a DOAC and switching

to a DOAC anticoagulants (DOACs) dosing of DOACs for various indications switching from a DOAC and switching Linda Kelly, PharmD, PhC, CACP Presbyterian Healthcare Services } Identify the FDA approved direct oral anticoagulants (DOACs) } Distinguish the differences in the dosing of DOACs for various indications

More information

Adherence to VKA treatments : What are the needs?

Adherence to VKA treatments : What are the needs? Adherence to VKA treatments : What are the needs? Marie-Camille Chaumais Antoine Béclère Hospital Clamart, France 1 No conflict of interest 2 1 According to NICE, between a third and a half of all medicines

More information

Management of Patients with Atrial Fibrillation and Stents: Is Three Drugs Too Many?

Management of Patients with Atrial Fibrillation and Stents: Is Three Drugs Too Many? Management of Patients with Atrial Fibrillation and Stents: Is Three Drugs Too Many? Neal S. Kleiman, MD Houston Methodist DeBakey Heart and Vascular Center, Houston, TX Some Things Are Really Clear 2013

More information

Despite the approval of multiple novel agents,

Despite the approval of multiple novel agents, Hosp Pharm 2015;50(1):018 024 2015 Thomas Land Publishers, Inc. www.hospital-pharmacy.com doi: 10.1310/hpj5001-018 Critical Care An Evaluation of Intravenous Vitamin K for Warfarin Reversal: Are Guideline

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

2019 COLLECTION TYPE: MIPS CLINICAL QUALITY MEASURES (CQMS) MEASURE TYPE: Process

2019 COLLECTION TYPE: MIPS CLINICAL QUALITY MEASURES (CQMS) MEASURE TYPE: Process Quality ID #326 (NQF 1525): Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy National Quality Strategy Domain: Effective Clinical Care Meaningful Measure Area: Management of Chronic

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