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Oral Anticoagulants 4/26/2018 Disclosure • Kelsey Gander, PharmD, BCACP Direct Oral Anticoagulants: – Declares no financial relationships pertinent to this session When to Use and How to Choose – Declares off-label use of medication will not be discussed during this presentation. Kelsey Gander, PharmD, BCACP Minnesota Academy of Physician Assistants Conference May 11th, 2018 Abbreviations Objectives • DOAC= direct oral anticoagulant 1) Compare and contrast the efficacy and safety • VTE= venous thromboembolism • DVT= deep vein thrombosis of direct oral anticoagulants (DOACs) to • PE= pulmonary embolism warfarin • A-fib, AF= atrial fibrillation 2) Identify which anticoagulant would be most • ESRD= end stage renal disease appropriate for a given patient • ACC= American College of Cardiology • AHA= American Heart Association 3) Recognize when it would not be appropriate • HRS= Heart Rhythm Society to use a DOAC • BID= twice daily Appropriate Abbreviations Patient Case JJ is a 66 y/o male who was hospitalized for pulmonary • NOAC embolism and initiated on anticoagulant therapy one week – Novel Oral Anticoagulant ago. – Chief complaint: – Non-Vitamin K Oral Anticoagulant • Presents to clinic today for INR check, post-hospital discharge follow- up • TSOAC – Past medical history: • Hypertension, hyperlipidemia, osteoarthritis, erectile dysfunction, – Target Specific Oral Anticoagulant BPH, type 2 diabetes, peripheral artery disease – Home medications • DOAC • Acetaminophen 650mg po every 6 hours PRN – Direct Oral Anticoagulant • Diazepam 5mg po at bedtime PRN anxiety • Enoxaparin 80mg sub-q BID • • Glipizide XL 10mg po every morning Say “no” to NOAC and “do” the DOAC • Lisinopril 20mg po daily • Nitroglycerin 0.4mg SL tablet PRN chest pain • Warfarin 5mg po daily 1 4/26/2018 Labs/Vitals Labs from Today • BP: 148/74 mmHg, HR: 73 bpm • INR • Height: 5’7”, Weight: 167 lbs, CrCl: 54.8 ml/min – Point of care > 6 – Venous (confirmatory) 10.8 • Labs from hospital admission (3/13): 141 105 18 12.5 • PT 101 7.25 141 3.8 27 1.24 38 – 117.8 seconds – INR 1.0, PT 10.2 seconds (3/13/2015) • Plan: discontinue enoxaparin, hold warfarin until – A1c 9.9% (1/2015) INR recheck in 4 days, sent prescription for oral – LDL 134mg/dl (1/2015) vitamin K 5mg x 1 dose to pharmacy – ALT 22 IU/L, AST 20 IU/L (2/2015) • Over the next 2 weeks, JJ has to come frequently for INR checks (1-2x/week) and use enoxaparin injections to bridge when INR subtherapeutic • “I’m not taking this $*#& anymore!” Only FDA approved for VTE prophylaxis in hospitalized adult patients with acute medical illness and risk factors for VTE https://www.bevyxxa.com/hcp/about-bevyxxa-betrixaban-capsules/. Accessed April 22, 2018. http://www.nature.com/nrcardio/journal/v11/n5/fig_tab/nrcardio.2014.22_F1.html 2 4/26/2018 Pharmacokinetics and Pharmacodynamics DOAC FDA-labeled Indications Dabigatran Rivaroxaban Apixaban Edoxaban Characteristic Dabigatran Rivaroxaban Apixaban Edoxaban (Pradaxa®) (Xarelto®) (Eliquis®) (Savaysa®) MOA Factor II Factor Xa Factor Xa Factor Xa Non-valvular X X X X inhibitor inhibitor inhibitor inhibitor A-fib Impact on aPTT (~2x) aPTT 40% aPTT, PT, and aPTT, PT, and DVT treatment X (following X X X (following coagulation INR INR INR INR parenteral parenteral assay therapy) therapy) DVT (prevent X X X Peak 1-3 hr 2-4 hr 3-4 hr 1-2 hr recurrence) T1/2 12-17 hr 5-13 hr 8-15 hr 10-14 hr PE treatment X (following X X X (following % renal 80% 36% 27% ~50% parenteral parenteral elimination therapy) therapy) Dialyzable Yes No No No PE (prevent X X X recurrence) CYP No CYP3A4 CYP3A4 No DVT/PE Only approved X X metabolism Prophylaxis for hip P-gp substrate Yes Yes Yes Yes (hip/knee replacement replacement) P radaxa® [package insert]. Ridgefield, CT: Boeh ringer In gelheim P harmace u ticals, In c.; 2 0 1 8 . X are lto ® [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2017. P radaxa® [package insert]. Ridgefield, CT: Boeh ringer In gelheim P harmace u ticals, In c.; 2 0 1 8 . Eliq u is® [package insert]. Princeton, NJ: Bristol -Myers Squ ib b Co mpany; 2 018 . X are lto ® [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2017. Savaysa® [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2017. Eliq u is® [package insert]. Princeton, NJ: Bristol -Myers Squ ib b Co mpany; 2 018 . Savaysa® [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2017. Standard Dosing Dabigatran Rivaroxaban Apixaban Edoxaban (Pradaxa®) (Xarelto®) (Eliquis®) (Savaysa®) Non-valvular 150mg twice 20mg once daily 5mg twice daily 60mg once daily A-fib daily with evening meal DVT /PE 150mg twice 15mg twice daily 10mg twice daily 60mg once daily treatment daily (following with food x 21 for 7 days, then (following DVT/PE parenteral days, then 20mg 5mg twice daily parenteral therapy) daily therapy) DVT/PE (prevent 150mg twice 10mg once daily 2.5mg twice daily recurrence) daily with or without (after >6 months food (after >6 of tx) months of tx) DVT/PE Hip - 110mg Hip – 10mg daily Hip - 2.5mg twice Prophylaxis 1-4 hours after x 35 days daily for 35 days, (hip/knee surgery, then Knee - 2.5mg replacement) 220mg once daily Knee – 10mg twice daily x 12 for 28-35 days daily x 12 days days P radaxa® [package insert]. Ridgefield, C T: Boeh ringer In gelheim P harmace u ticals, In c.; 2 0 1 8 . X are lto ® [p ackage in se rt]. Titu sville , NJ: Janssen P h armace u ticals, In c.; 2 0 1 7 . Eliq u is® [package insert]. Princeton, NJ: Bristol -Myers Squ ib b Co mpany; 2 018 . Savaysa® [p ackage in se rt]. Baskin g Rid ge, NJ: Daiichi Sankyo, In c.; 2 0 1 7. CHEST 2016 Guidelines Clinical Trial Efficacy/Safety Data Acute VTE w/o cancer DOAC over warfarin (Grade 2B) If DOAC not used, then warfarin preferred vs LMWH (Grade 2C) • Compared to warfarin for DVT/PE: Acute VTE w/ cancer LMWH over warfarin (grade 2B) or DOAC (Grade 2C) – Dabigatran Location of management Treat at home or discharge early for low-risk VTE (Grade 2B) • RE-COVER I Duration of therapy 3 months • RE-COVER II • first provoked VTE (Grade 1B) – Rivaroxaban At least 3 months • First or second unprovoked VTE (Grade 1B) • EINSTEIN DVT Extended therapy • EINSTEIN PE • VTE w/ active cancer (Grade 1B) • First or second unprovoked VTE and low to mod. bleed risk (Grade 1B) – Apixaban Recurrent VTE Either change OAC to LMWH x 1 month or increase LMWH dose 25-33% • AMPLIFY (Grade 2C) – Edoxaban • HOKUSAI-VTE http://journal.publications.chestnet.org/article.aspx?articleid=2479255&resultClick=3#SummaryofRecommendati ons 3 4/26/2018 Dose Adjustments/Drug Interactions – Comparison to Warfarin DVT/PE Dabigatran Rivaroxaban Apixaban Edoxaban RE-COVER I&II EINSTEIN AMPLIFY HOKUSAI-VTE • Renal/body weight dose adjustments DVT&PE – Dabigatran Primary • CrCl <30ml/min – “no recommendations”... Do not use Efficacy – Rivaroxaban Endpoint • CrCl <30ml/min – avoid use (recurrent VTE, – Apixaban death) • No dose adjustment in renal impairment for DVT/PE – Studies did not enroll patients with ESRD on hemodialysis or CrCl<15ml/min Major bleeding – Edoxaban event • CrCl 15-50ml/min – 30mg once daily, <15ml/min – do not use DVT PE • Body weight <60kg – 30mg once daily Major or clinically • Drug interactions relevant non- – major bleeding P-gp inhibitors/inducers (all) – CYP3A4 inhibitors/inducers (apixaban and rivaroxaban) Adapted from Dobesh PP, Smythe MA. An Overview of Advances in Anticoagulation Therapy. American Pharmacists Association Annual Meeting. Attended March 30 th , 2015 P radaxa® [package insert]. Ridgefield, CT: Boeh ringer In gelheim P harmace u ticals, In c.; 2 0 1 8 . X are lto ® [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2017. Eliq u is® [package insert]. Princeton, NJ: Bristol -Myers Squ ib b Co mpany; 2 018 . Savaysa® [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2017. Convenience Patient Case • Dosing for DVT/PE: JJ reveals he stopped his warfarin as he was sick of taking – Dabigatran it and having his blood checked. His INR today is 1.2, and • 150mg BID after 5-10 days of parenteral anticoagulant he experiences a DVT due to non-compliance. His • Dabigatran capsules need to be kept in original container insurance covers any of the DOACs. Which is the best (cannot be kept in pillbox) choice for JJ? – Rivaroxaban a) Start enoxaparin 1mg/kg sub-q twice daily, restart • 15mg BID with food x 21 days, then 20mg daily with food warfarin, reinforce this is the only option for him – Apixaban b) Discontinue warfarin, switch to rivaroxaban 15mg by mouth twice daily for 21 days, then 20mg once daily • 10mg BID x 7 days, then 5mg BID (with food) – Edoxaban c) Discontinue warfarin, switch to apixaban 5mg twice daily • 60mg daily after 5-10 days of parenteral anticoagulant d) Discontinue warfarin, switch to dabigatran 150mg twice P radaxa® [package insert]. Ridgefield, CT: Boeh ringer In gelheim P harmace u ticals, In c.; 2 0 1 8 . daily X are lto ® [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2017. Eliq u is® [package insert]. Princeton, NJ: Bristol -Myers Squ ib b Co mpany; 2 018 . Savaysa® [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2017. Patient Case Summary – DVT/PE JJ reveals at his follow-up visit today that he stopped • Apixaban, rivaroxaban better options warfarin last week as he was sick of taking it and having his blood checked. His INR today is 1.2, and he (especially for younger, healthier patients) experiences a DVT due to non-compliance. His insurance – Take into account renal function, patient covers any of the DOACs. Which is the best choice for JJ? preferences, and
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