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Utah Medicaid Pharmacy and Therapeutics Committee Drug Utah Medicaid Pharmacy and Therapeutics Committee Drug Class Review Non-Vitamin K Anticoagulants for Venous Thromboembolism and Nonvalvular Atrial Fibrillation Direct Thrombin Inhibitors Dabigatran (Pradaxa, generic) Desirudin (Iprivask) Direct Factor Xa Inhibitors Apixaban (Eliquis) Betrixaban (Bevyxxa) Edoxaban (Savaysa) Fondaparinux (Arixtra) Rivaroxaban (Xarelto) Low Molecular Weight Heparins Dalteparin (Fragmin, generic) Enoxaparin (Lovenox, generic) AHFS Classification: 20:12.04.12 Direct Thrombin Inhibitors, 20:12.04.14 Direct Factor Xa Inhibitors, 20:12.04.16 Heparins Final Report October 2018 Review prepared by: Elena Martinez Alonso, B.Pharm., MSc MTSI, Medical Writer Valerie Gonzales, Pharm.D., Clinical Pharmacist Vicki Frydrych, B.Pharm., Pharm.D., Clinical Pharmacist Lauren Heath, Pharm.D., MS, BCACP, Assistant Professor (Clinical) Michelle Fiander, MA, MLIS, Research Assistant Professor, Evidence Synthesis Librarian Joanne LaFleur, PharmD, MSPH, Associate Professor University of Utah College of Pharmacy University of Utah College of Pharmacy, Drug Regimen Review Center Copyright © 2018 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved Contents Executive Summary ........................................................................................................................ 3 Introduction ..................................................................................................................................... 7 Table 1. FDA-Approved Indications for Non-Vitamin K Anticoagulants ............................. 8 Table 2. Dosage Recommendations for Non-Vitamin K Anticoagulants ............................... 9 Methods......................................................................................................................................... 12 Disease Overview ..................................................................................................................... 14 Guidelines Recommendations and Treatment Strategies ......................................................... 15 Table 3. Clinical Guidelines for Non-vitamin K Anticoagulants ......................................... 16 Pharmacology ............................................................................................................................... 19 Table 4: Pharmokinetics of Non-vitamin K Anticoagulants................................................. 19 Drug-drug Interactions .................................................................................................................. 20 Special Populations ....................................................................................................................... 21 Table 5: Special Population Information for Non-vitamin K Anticoagulants ...................... 22 Head-to Head Efficacy and Safety Comparisons .......................................................................... 25 Figure 1. PRISMA Flow Chart for Publication Screening ................................................... 25 Figure 2. Direct Comparative Efficacy Evidence of Direct Anticoagulants versus LMWHs for VTE Treatment and Prevention....................................................................................... 26 Summary of Guideline Recommendations and Findings Reported in SR/MAs and RCTs ..... 27 Table 6. Summary of Evidence Findings and Treatment Options for NVAF and VTE patients .................................................................................................................................. 27 Findings Reported in SR/MAs and RCTs for Venous Thromboembolism .............................. 28 Findings Reported in SR/MAs and RCTs for Non-valvular Atrial Fibrillation ....................... 33 Safety ............................................................................................................................................ 34 Table 7. Labeled Black Box Warnings and Most Common Adverse Events with Non- vitamin K Anticoagulants ..................................................................................................... 35 Summary ....................................................................................................................................... 36 References ..................................................................................................................................... 38 Appendix A: Literature Search Strategies .................................................................................... 43 Appendix B: List of Excluded Studies.......................................................................................... 47 Appendix C: Direct Evidence from Systematic Reviews ............................................................. 49 Appendix D: Randomized Controlled Trials Identified in the Included Systematic Reviews ..... 60 Appendix E: Characteristics of the Main Randomized Controlled Trials Identified in the Included Systematic Reviews ...................................................................................................................... 63 2 Executive Summary Introduction: Anticoagulation is indicated for the treatment of acute venous thromboembolism (VTE), reduction in the risk of recurrent VTE, VTE prophylaxis following major surgery (eg, total hip and knee replacement), and VTE prophylaxis in patients hospitalized for an acute medical illness. Anticoagulation is also indicated for stroke and systemic embolism prevention in patients with non-valvular atrial fibrillation (NVAF). The main objective of anticoagulation is to prevent thromboembolism and further complications. Many anticoagulant therapies are currently available in the United States. This report evaluates head-to-head efficacy and safety comparisons among the following non-vitamin K anticoagulants: 2 direct thrombin inhibitors (dabigatran and desirudin), 5 direct factor Xa inhibitors (apixaban, betrixaban, edoxaban, fondaparinux, and rivaroxaban), and 2 low molecular weight heparins (LMWHs, dalteparin and enoxaparin). Each of the agents are indicated for VTE treatment or prophylaxis in various patient subgroups at once or twice daily dosing depending on the agent and indication. Apixaban, dabigatran, edoxaban, and rivaroxaban are additionally indicated for the prevention of stroke and systemic embolism in patients with NVAF. Dabigatran and the factor Xa inhibitors apixaban, betrixaban, edoxaban, and rivaroxaban are available as oral formulations. Desirudin, fondaparinux, and the 2 LMWHs are available as parenteral subcutaneous formulations. Although dabigatran and factor Xa inhibitors offer advantages over the traditional anticoagulant warfarin (ie, no need for routine laboratory monitoring, fixed oral dosing, rapid onset of action, and fewer drug interactions), individualization of therapy is important. Drug-drug interactions and renal function may limit the use of some agents. The 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guideline for the management of atrial fibrillation recommends oral anticoagulants for patients with NVAF who have history of stroke, transient ischemic attack, or CHA2DS2- . Warfarin, dabigatran, rivaroxaban, or apixaban are recommended as first-line anticoagulant therapy options. VASc score ≥ 2 For acute treatment of VTE, the 2016 American College of Chest Physicians (CHEST) guideline recommends dabigatran or the oral factor Xa inhibitors, apixaban rivaroxaban, or edoxaban in preference to vitamin K antagonist (VKA) therapy (ie, warfarin) for at least three months following deep vein thrombosis (DVT) of the leg or pulmonary embolism (PE) in patients without cancer. In cancer patients with DVT of the leg or PE (“cancer- associated thrombosis”), LMWHs for at least 3 months are preferred over VKA therapy, dabigatran, rivaroxaban, apixaban, or edoxaban. Some patients may continue extended treatment beyond 3 months either with the initial therapy or alternative therapy according to the patient’s response or preferences. For VTE prophylaxis following THR or TKR surgery, the 2012 CHEST guideline recommends LMWH therapy for at least 10 to 14 days over other agents (ie, fondaparinux, 3 dabigatran, apixaban, rivaroxaban, VKA, unfractionated heparin, aspirin, and intermittent pneumatic compression device). In patients declining injectable formulations, apixaban or dabigatran are recommended. Extended-thromboprophylaxis is recommended for up to 35 days. For VTE prophylaxis in acutely ill hospitalized medical patients at high risk of thrombosis, the 2012 CHEST guideline recommends LMWH, unfractionated heparin, or fondaparinux during the hospital stay or period of immobilization. Efficacy: After performing a systematic literature search for systematic review/meta- analysis (SR/MA) and randomized controlled trial (RCT) evidence containing head-to-head efficacy and safety comparisons among non-vitamin K anticoagulants, 16 publications were identified. Twelve additional publications were found by checking the reference lists of related articles. Non-valvular atrial fibrillation For the prevention of stroke or systemic embolism in patients with NVAF, no head-to-head RCTs comparing direct thrombin inhibitors with factor Xa inhibitors or comparing factor Xa inhibitors with one another were identified. Venous Thromboembolism For the treatment or prevention of VTE, no head-to-head RCTs comparing direct thrombin inhibitors with factor Xa inhibitors or comparing factor Xa inhibitors with one
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