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1 Update on New Anticoagulants (Apixaban, Dabigatran and Rivaroxaban) Patient Safety Daniel B. DiCola, MD and Paul Ament,, Pharm.D Excela Heath, Latrobe, PA Disclosures: Paul Ament discloses that he receives honorarium and is on the speaker s bureau for Pfizer, Merck and Janssen. Conflicts of interest have been resolved prior to this presentation. The speakers have attested that their presentation will be free of all commercial bias toward a specific company and its products. The speakers indicated that the content of the presentation WILL include discussion of unapproved or investigational uses of products or devices. Dr. Dicola has no disclosures.

2 NEW ORAL ANTICOAGULANTS (NOAC s) Paul W. Ament, PharmD Daniel B. Dicola, MD Excela Health, Latrobe Hospital Family Medicine Residency Paul W. Ament, PharmD Manager: Clinical Pharmacy Excela Health Instructor: Family Medicine - Jefferson Medical College Faculty: Latrobe Area Hospital Excela Health Family Medicine Residency Goals Review Mechanism of Action of the NOAC s Compare Pharmacokinetic Properties and Drug Interactions of the NOAC s Discuss Warfarin and LMW (Heparins) with the NOAC s in Chronic Atrial Fibrillation and Treatment of Thromboembolic Disease Review ACCP Guidelines for the above Discuss Clinical Management of Bleeding with the NOAC s 1

3 DISCLOSURE Speakers Panel: Janssen Merck Pfizer Which of the Following is False 1. CHADS 2 and CHADS2 VASc is a Method To Determine Risk of Stroke in Atrial Fibrillation 2. In the RE-LY Trial the Average CHADS2 Score was >3 3. In the Rocket AF Trial the Average CHADS2 Score was >3 4. In the Aristotle Trial the Average CHADS2 Score was = 2 The ACCP Guidelines Prefer Which Therapy for Atrial Fibrillation with a CHADS 2 Score of 2 or Greater: 1. Aspirin 325mg Once Daily 2. Warfarin to Maintain an INR Dabigatran 150mg BID 4. All The Above 2

4 Bleeding Complications from the NOAC s may be Reversed with the Following: 1. Fresh Frozen Plasma (FFP) 2. Prothrombin Complex Concentrate (PCC) 3. Vitamin K Which of the Following is TRUE Regarding NOAC Dosing in Atrial Fibrillation: 1. Dabigatran dose = 150mg Once Daily for CrCl < 30ml/min 2. Rivaroxaban dose = 15mg Once Daily for CrCl = 40ml/min 3. Apixaban does not require dose adjustment based on renal function What Medication Am I Thinking Of? New Pharmacologic Agent Alternative for Standard of Care Drug Pricing >> than Standard of Care FDA Indications Continue to Expand Fixed Dosing Dose Adjustment for CrCl <30ml/min No Monitoring No Approved Reversal Agent 3

5 LOVENOX Dabigatran (Pradaxa ) Reduce Risk of Stroke and Systemic Embolism in Patients with Non-Valvular Atrial Fibrillation 150mg BID CrCl ml/min 75mg BID 4

6 Apixaban (Eliquis ) Reduce Risk of Stroke and Systemic Embolism in Patients with Non-Valvular Atrial Fibrillation 5mg BID 2.5mg BID With 2 of the Following: Age >80yr Weight <60 kg Serum Creatinine >1.5mg/dl Rivaroxaban (Xarelto ) DVT Prophylaxis after Knee or Hip Replacement Surgery Knee: 10mg Once Daily x 12 Days Hip: 10mg Once Daily x 35 Days CrCl < 30 ml/min Contraindicated Stroke / Systemic Embolism Risk Reduction in Patients with Non-Valvular Atrial Fibrillation CrCl >50 ml/min 20mg Once Daily with PM Meal CrCl 15-50ml/min 15mg Once Daily with PM Meal Rivaroxaban (Xarelto ) Treatment of DVT / PE 15mg BID x21 Days 20mg Once Daily with Food CrCl < 30 ml/min Contraindicated Reduction in the Risk of Recurrence of DVT / PE 20mg Once Daily with Food CrCl < 30 ml/min Contraindicated 5

7 Dabigatran Apixaban Edoxaban Rivaroxaban MOA Direct Thrombin Inhibitor Factor Xa Inhibitor Factor Xa Inhibitor Factor Xa Inhibitor Bioavailability 6-8% 50% 60% 80% Time to Peak 2 hrs 3 hrs 1-2 hrs 2-3 hrs Half-life hrs 7-11hrs 9-11 hrs 5-9 hrs (11-13 hrs elderly) Excretion Renal = 80% Renal = 27% Renal = 35-50% Renal = 33% Apixaban Dabigatran Rivaroxaban Induce CYP / P-gp Rifampin / Carbamaz / Phenytoin / Barbs / St John s Wort Inhibit CYP / P-gp Azoles (Keto/Itra) Vir HIV Agents Anticoag / NSAID/ Antiplatelet / SSRI / SNRI Avoid 2.5mg BID (*avoid if on 2.5mg) Avoid (Rifampin) CrCl 30-50ml/min 75 mg BID (*Dronedarone/ Keto) (* avoid if CrCl <30) Avoid Avoid (*Conivaptan) Bleeding Bleeding Bleeding Weak Inhibitor CYP / P-gp Risk vs Benefit CrCl <50 and Azithro/Amiodarone/ Dronedarone/ Diltiazem/Verapamil Daniel B. Dicola, MD Instructor: Family Medicine - Jefferson Medical College Faculty: Latrobe Area Hospital Excela Health Family Medicine Residency 6

8 Conflicts of Interest None What is an Ideal Anticoagulant? An Ideal Anticoagulant Infrequent or no monitoring One size fits all fixed dose Minimal drug interactions Minimal food interactions Oral Quick onset 7

9 An Ideal Anticoagulant 100% effective Reversible specific antidote Once daily Low incidence of adverse effects heparin induced thrombocytopenia (HIT) An Ideal Anticoagulant Affordable No evidence of hypercoagulability / thrombotic events No need for bridging An Ideal Anticoagulant Selective Clearance multi-organ clearance Long-term safety data 8

10 9 Atrial Fibrillation Who Needs Anticoagulation in AFIB? Stroke Risk Based on Score C H A 2 DS 2 VAS C C H F H T N A G E 7 5 D M S T R O K E V A S C U L A R A G E 6 5 F E M A L E S E X > >

11 3 Major Risk Factors Prior Thromboembolism Age > 75 DM + CHF together Rely Trial A Common Theme for NOACs Non-inferior for CVA prevention Decreased incidence of stroke Slight increase in incidence of GI bleed Decrease in deaths 10

12 Weaknesses of Rely Trial and Dabigatran BID dosing GI side effects 2 year study CHADS 2 score % 2 34% % Weaknesses of Rely Trial and Dabigatran Lack of elderly patients Lack of renal impairment Weaknesses of Rely Trial and Dabigatran No antidote Drug interactions anticoagulant effect potentiated by verapamil and amiodarone PPI interaction Thrombotic events at discontinuation Higher incidence of Acute Coronary Syndromes while being treated 11

13 Realign Trial Realign Trial Weakness Introduced immediately-post operatively Conclusion Increased thrombotic events Increased bleeding?? Safety / Efficacy initiated > 3 months Premature Termination Rocket AF Trial NEJM 12

14 Rocket AF Trial Weaknesses No antidote Renal Impairment Thrombotic events at discontinuation INR between % of the time Strengths CHADS 2 score 3 or greater 90% of the time Significant Drug Interactions Diltiazem Verapamil Amiodarone Aristotle AF 13

15 Aristotle AF Superiority in Embolic CVA Prophylaxis Mean CHADS 2 score 2.1 Exclusion criteria of CR >2.5 INR Monitoring with POC device Aristotle AF Subgroup data: More impressive reduction of Hemorrhagic CVA Reduction in GI bleeding 14

16 Averoes Trial Averoes Trial Compared Apixaban vs ASA in CVA prophylaxis in Afib. Apixaban decreases risk of stroke or systemic emboli without a risk of increased bleeding 80% on low dose 81 mg ASA Bleeding incidence 15

17 16

18 THE BOTTOM LINE Recurrence Stroke / Systemic embolism VTE Apixaban (Aristotle) 1.6% Warf 1.27% Apix Dabigatran (Re-ly) 1.71% Warf 1.11% Dabi Rivaroxaban (Rocket-AF) 2.4% Warf 2.1% Rivarox Rivaroxaban (Einstein) 2.3% Warf 2.1% Rivarox NNT Major bleeding 3.09% Warf 2.13% Apix 3.6% Warf 3.3% Dabi 5.4% Warf 5.6% Rivarox 1.7% Warf 1.0% Rivarox NNT Review of CHEST Supplement 17

19 Review of CHEST Supplement ACCP guidelines for 2012 CHADS 0 No therapy CHADS 1 Oral anticoagulation CHADS 2 or greater Oral anticoagulation, recommendation of Dabigatran over Warfarin for oral anticoagulation Level of Evidence: Grade 2B 18

20 Einstein DVT Einstein PE 19

21 Einstein Extension Study Compared Rivaroxaban vs Placebo in long term Prophylaxis (6-12 months) Rivaroxaban superior to Placebo Record Trials Weakness of Record Trial Short term prophylaxis Record 2 compares days of Rivaroxaban to days LMWH Venography based diagnosis Compared to enoxaparin 40 mg per day in record

22 Bottom Line CHEST Supplement Supplement recommends LMWH as agent of choice for orthopedic prophylaxis Level of Evidence: Grade 2B The Future 9 drugs in pipeline Possible uses ACS Medical prophylaxis DVT treatment PE treatment 21

23 ACS Apraise2 Trial Apixaban with Antiplatelet Therapy After Acute Coronary Syndrome NEJM (8) Terminated secondary to increase bleeding Medical Prophylaxis Adopt Trial: Apixaban VS. Enoxaparin for prophylaxis in medically ill patients Magellan Trial Rivaroxaban for Thromboprophylaxis in acutely ill medical patients» NEJM (6) Significant increase in bleeding TRANSITION TO NOAC Warfarin Enoxaparin / Fondaparinux / UFH Apixaban Initiate INR < 2 Initiate when next scheduled dose due Dabigatran Initiate INR < 2 Initiate when next scheduled dose due Rivaroxaban Initiate INR <3 Initiate when next scheduled dose due 22

24 TRANSITION FROM NOAC Apixaban Dabigatran Rivaroxaban Enoxaparin Fondaparinux UFH Initiate when next scheduled dose due Wait 12 Hrs; CrCl < 30ml/min Wait 24 Hrs Initiate when next scheduled dose due TRANSITION TO WARFARIN Warfarin Apixaban DC Apixaban Bridge w/parenteral Agent Dabigatran CrCl >50 Overlap 3 days CrCl Overlap 2 days CrCl Overlap 1 day Rivaroxaban DC Rivaroxaban Bridge w/ Parenteral Agent TIME TO DELAY SURGERY Agent CrCl Low Risk High Risk (ml/min) Dabigatran >50 1 day 2 days days 4 days <30 4 days 6 days Apixaban >30 1 day 2 days <30 2 days 4 days Rivaroxaban >30 1 day 2 days <30 2 days 4 days Low = Colonoscopy, Breast biopsy, minor orthopedic, cardiac cath High = Surgery: Abdominal, Cardiac, Kidney, Neuro, Prostate, Spinal, Vascular Clev Clin J Med 2013;80(7):

25 BLEEDING MANAGEMENT Discontinue: Short T ½ Eliminated hours Supportive Management FFP (Does Not Reverse DTI / Xa) Compress Bleeding Sites Gastric Lavage / Charcoal < 3 Hours of Dose? Dialysis => Dabigatran BLEEDING MANAGEMENT Prothrombin Complex Concentrate (Kcentra ) FDA Approved for Warfarin Reversal units / kg Andexanet Binds to Xa Molecule Neutralization Within Minutes Phase II Studies with Apixaban / Rivaroxaban CLINICAL ISSUES Reversibility Quantitative Assay Interacting Drugs Extremes of Weight Emergency Procedures / Surgery Treatment Failures Valvular Heart Disease 24

26 WHEN TO USE WARFARIN Compromised Renal Function Studies Excluded CrCl <30 ml/min Valvular Heart Disease Edoxaban Bioprosthetic DAPT Satisfied with Warfarin If It s Fixed Don t Break It MONTHLY COST Warfarin $4 Copay for INR $?? Apixaban 5mg $ mg $319 Dabigatran 150mg $350 75mg $350 Rivaroxaban 20mg $319 15mg $319 AWP McKesson March 2014 SUMMARY Simplicity Rapid Onset Paradigm Shift LMWH Reluctance in 90 s Developed as Warfarin Alternative Non-Inferior Superior Efficacy / Safety NOAC s vs Warfarin Major Bleeding Intra Cranial Bleeding Overall Mortality 10% Clinical Role is Rapidly Evolving 25

27 Which of the Following is False 1. CHADS 2 and CHADS2 VASc is a Method To Determine Risk of Stroke in Atrial Fibrillation 2. In the RE-LY Trial the Average CHADS2 Score was >3 3. In the Rocket AF Trial the Average CHADS2 Score was >3 4. In the Aristotle Trial the Average CHADS2 Score was = 2 The ACCP Guidelines Prefer Which Therapy for Atrial Fibrillation with a CHADS 2 Score of 2 or Greater: 1. Aspirin 325mg Once Daily 2. Warfarin to Maintain an INR Dabigatran 150mg BID 4. All The Above Bleeding Complications from the NOAC s may be Reversed with the Following: 1. Fresh Frozen Plasma (FFP) 2. Prothrombin Complex Concentrate (PCC) 3. Vitamin K 26

28 Which of the Following is TRUE Regarding NOAC Dosing in Atrial Fibrillation: 1. Dabigatran dose = 150mg Once Daily for CrCl < 30ml/min 2. Rivaroxaban dose = 15mg Once Daily for CrCl = 40ml/min 3. Apixaban does not require dose adjustment based on renal function 27

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