Edoxaban

(Savaysa®)

Edoxaban

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Drug updated on 5/17/2024

Dosage FormTablet (oral; 15 mg, 30 mg, 60 mg)
Drug ClassFactor Xa inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF).
  • Indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.

Summary
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  • Edoxaban (Savaysa) is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, as well as for the treatment of deep vein thrombosis and pulmonary embolism following initial therapy with a parenteral anticoagulant.
  • Thirty-nine studies provided key findings about Savaysa's safety and effectiveness across various populations.
  • In elderly patients aged over 65 years, edoxaban shows potential benefits in reducing mortality and major or clinically relevant bleeding events compared to vitamin K antagonists.
  • For obese patients with atrial fibrillation, edoxaban was found safer and more effective than vitamin K antagonists, showing significant reductions in the odds of ischemic stroke, hemorrhagic stroke, systemic embolism, and major bleeding.
  • While it demonstrated comparable efficacy among active cancer patients when compared to other direct oral anticoagulants (DOACs), edoxaban may not be the safest option due to an increased risk of major bleeding relative to apixaban.
  • Edoxaban has been shown effective for treating deep vein thrombosis (DVT) and pulmonary embolism (PE), offering reduced rates of major bleeding compared to conventional anticoagulation therapies.
  • When used by individuals with nonvalvular atrial fibrillation instead of warfarin, edoxaban significantly lowers the risks associated with ischemic strokes, alongside lowering the chances of experiencing any form of severe blood loss incidents.
  • Evidence suggests that DOACs, including edoxaban, are not inferior to low molecular weight heparin regarding effectiveness, safety, and mortality during pharmacologic venous thromboembolism (VTE) prophylaxis amongst individuals undergoing hip fracture surgery.

Product Monograph / Prescribing Information

Document TitleYearSource
Savaysa (edoxaban) Prescribing Information.2023Daiichi Sankyo, Inc., Basking Ridge, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Safety outcomes of direct oral anticoagulants in older adults with atrial fibrillation: a systematic review and meta-analysis of (subgroup analyses from) randomized controlled trials.2024GeroScience
Safety and efficacy of direct oral anticoagulants in comparison to warfarin in obese patients with atrial fibrillation: a systematic review and meta-analysis.2024Health Science Reports
Comparing anticoagulation strategies for venous thromboembolism associated with active cancer: a systematic review and meta-analysis.2024JACC. CardioOncology.
Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of deep vein thrombosis.2023The Cochrane Database of Systematic Reviews
Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of pulmonary embolism.2023The Cochrane Database of Systematic Reviews
Effectiveness and safety of edoxaban versus warfarin in patients with nonvalvular atrial fibrillation: a systematic review and meta-analysis of observational studies.2023Frontiers in Pharmacology
The effectiveness and safety of direct oral anticoagulants compared to conventional pharmacologic thromboprophylaxis in hip fracture patients: a systematic review and meta-analysis of randomized controlled trials.2023Orthopaedics & Traumatology, Surgery & Research
Efficacy and safety of direct oral anticoagulants for stroke prevention in older patients with atrial fibrillation: a network meta-analysis of randomized controlled trials.2023Journal of the American Heart Association
Severe bleeding risk of direct oral anticoagulants versus Vitamin K antagonists for stroke prevention and treatment in patients with atrial fibrillation: a systematic review and network meta-analysis.2023Cardiovascular Drugs and Therapy
Antithrombotic therapy and cardiovascular outcomes after transcatheter aortic valve implantation in patients without indications for chronic oral anticoagulation: a systematic review and network meta-analysis of randomized controlled trials.2023European Heart Journal Cardiovascular Pharmacotherapy
Efficacy and safety of renal function on edoxaban versus warfarin for atrial fibrillation: a systematic review and meta-analysis.2023Medicines
Direct oral anticoagulation in atrial fibrillation and heart valve surgery-a meta-analysis and systematic review.2022Therapeutic Advances in Cardiovascular Disease
Direct oral anticoagulants compared with dalteparin for treatment of cancer-associated thrombosis: a living, interactive systematic review and network meta-analysis.2022Mayo Clinic Proceedings
Short-term efficacy and safety of edoxaban for venous thromboembolism after total hip or knee arthroplasty: a systematic review and meta-analysis.2022European Review for Medical and Pharmacological Sciences
Optimal stroke preventive strategy for patients aged 80 years or older with atrial fibrillation: a systematic review with traditional and network meta-analysis.2022Age and Ageing
Real-world evidence comparing oral anticoagulants in non-valvular atrial fibrillation: a systematic review and network meta-analysis.2022Future Cardiology
A network meta-analysis of direct factor Xa inhibitors for the treatment of cancer-associated venous thromboembolism.2022Vascular
The use of non-vitamin K oral anticoagulants in dialysis patients—A systematic review.2022Seminars in Dialysis
Oral anticoagulant agents in patients with atrial fibrillation and CKD: a systematic review and pairwise network meta-analysis.2021American Journal of Kidney Disease
A network meta-analysis of non-vitamin K antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and diabetes mellitus.2021Acta Cardiologica
The association of fracture risk in atrial fibrillation patients and long-term anticoagulant therapy category: a systematic review and meta-analysis.2021PeerJ
Risk of intracranial hemorrhage with direct oral anticoagulants: a systematic review and meta-analysis of randomized controlled trials.2021Journal of Neurology
Major gastrointestinal bleeding risk with direct oral anticoagulants: Does type and dose matter? - A systematic review and network meta-analysis.2021European Journal of Gastroenterology & Hepatology
Ranking the efficacy of anticoagulants for the prevention of venous thromboembolism after total hip or knee arthroplasty: a systematic review and a network meta-analysis.2021Pharmacological Research
Oral anticoagulant agents in patients with atrial fibrillation and CKD: a systematic review and pairwise network meta-analysis.2021American Journal of Kidney Diseases
The risk of gastrointestinal bleeding between non-vitamin K antagonist oral anticoagulants and vitamin K antagonists in the Asian atrial fibrillation patients: a meta-analysis.2021International Journal of Environmental Research and Public Health
The risk of gastrointestinal hemorrhage with non-vitamin K antagonist oral anticoagulants: a network meta-analysis.2021Medicine
A network meta-analysis comparing osteoporotic fracture among different direct oral anticoagulants and vitamin K antagonists in patients with atrial fibrillation.2021Journal of Bone Metabolism
Pharmacogenetics of direct oral anticoagulants: a systematic review.2021Journal of Personalized Medicine
Efficacy and safety of anticoagulants for postoperative thromboprophylaxis in total hip and knee arthroplasty: a PRISMA-compliant Bayesian network meta-analysis.2021PLoS One
The efficacy and safety of edoxaban versus warfarin in preventing clinical events in atrial fibrillation: a systematic review and meta-analysis.2021The Anatolian Journal of Cardiology
Reappraisal of non-vitamin K antagonist oral anticoagulants in atrial fibrillation patients: a systematic review and meta-analysis.2021Frontiers in Cardiovascular Medicine
Comparative efficacy and safety of warfarin care bundles and novel oral anticoagulants in patients with atrial fibrillation: a systematic review and network meta-analysis.2020Scientific Reports
Non-vitamin K antagonist oral anticoagulants in Asian patients with atrial fibrillation: evidences from the real-world data.2020Heart Failure Reviews
Direct oral anticoagulants for the treatment of acute venous thromboembolism associated with cancer: a systematic review and meta-analysis.2020Thrombosis and Haemostasis
Safety and efficacy of oral anticoagulant therapies in patients with atrial fibrillation undergoing percutaneous coronary intervention: a network meta-analysis.2020Journal of Cardiovascular Pharmacology and Therapeutics
Non-vitamin K antagonist oral anticoagulants in elderly patients with atrial fibrillation: a systematic review with meta-analysis and trial sequential analysis.2019Archives of Gerontology and Geriatrics
Direct oral anticoagulants in patients with venous thromboembolism and thrombophilia: a systematic review and meta-analysis.2019Journal of Thrombosis and Haemostasis
Non-vitamin K oral anticoagulants in nonvalvular atrial fibrillation: a network meta-analysis.2019Scandinavian Cardiovascular Journal
Causes of death in patients with venous thromboembolism anticoagulated with direct oral anticoagulants: a systematic review and meta-analysis.2018Seminars in Thrombosis and Hemostasis

Clinical Practice Guidelines

Document TitleYearSource
2023 ACC/AHA/ACCP/HRS guideline for the diagnosis and management of atrial fibrillation: a report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines.2024Journal of the American College of Cardiology
Practical guide for anticoagulant and antiplatelet reversal in clinical practice.2023Pharmacy
2021 European Heart Rhythm Association practical guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation.2021Europace
American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism.2020Blood Advances
The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society comprehensive guidelines for the management of atrial fibrillation.2020Canadian Journal of Cardiology
2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).2020European Heart Journal
2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes.2020European Heart Journal
Venous thromboembolic diseases: diagnosis, management and thrombophilia testing.2020NICE
2019 ESC guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS).2020European Heart Journal
Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO clinical practice guideline update.2020Journal of Clinical Oncology
SBA 2020: Regional anesthesia guideline for using anticoagulants update.2020Brazilian Journal of Anesthesiology
2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a Report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines and the Heart Rhythm Society in collaboration with the Society of Thoracic Surgeons.2019Circulation