Edoxaban

(Savaysa®)

Savaysa®

Drug updated on 12/11/2024

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.

Latest News

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Summary
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  • This summary is based on the review of 51 systematic review(s)/meta-analysis(es). [1-51]
  • In elderly patients (≥75 years), direct oral anticoagulants (DOACs), particularly apixaban and edoxaban, demonstrate fewer thromboembolic events and lower bleeding risks compared to vitamin K antagonists (VKAs), supporting their use in this population.
  • In patients with end-stage kidney disease on dialysis, factor Xa inhibitors (apixaban, rivaroxaban) effectively reduce the risk of stroke or systemic embolism (SSE) without increasing major bleeding, indicating their safety and efficacy in this high-risk group.
  • In obese patients with atrial fibrillation (AF), DOACs show superior safety and efficacy profiles compared to VKAs, making them the preferred anticoagulant option in this population.
  • In cancer patients, both apixaban and edoxaban are effective for venous thromboembolism (VTE) prevention, with apixaban potentially offering antithrombotic benefits without an increased risk of bleeding.
  • Edoxaban is associated with a lower risk of major bleeding compared to warfarin, with a hazard ratio (HR) of 0.58 (95% confidence interval (CI): 0.49-0.69), indicating a significant safety advantage in this outcome.
  • In patients with cancer, apixaban demonstrated a lower risk of major bleeding compared to edoxaban, with a hazard ratio of 0.38 (95% CI: 0.15-0.93), suggesting a preferable safety profile for apixaban in this population.
  • There is no significant difference in the risk of gastrointestinal bleeding (GIB) between edoxaban and warfarin, with an odds ratio of 0.95 (95% CI: 0.79-1.13), indicating similar safety in this aspect.
  • Edoxaban also shows a reduced risk of intracranial hemorrhage compared to warfarin, with a relative risk (RR) of 0.38 (95% CI: 0.29-0.48), reinforcing its safety in preventing severe bleeding events.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Factor Xa Inhibitors Versus Vitamin K Antagonists in Atrial Fibrillation Patients with End-Stage Kidney Disease on Dialysis: A Meta-Analysis2024Clinical and Applied Thrombosis/Hemostasis
Antithrombotic prophylaxis following total knee arthroplasty: a level I Bayesian network meta-analysis2024European Journal of Orthopaedic Surgery & Traumatology
Effectiveness of Novel Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis2024Cureus
Safety and efficacy of direct oral anticoagulants in comparison to warfarin in obese patients with atrial fibrillation: A systematic review and meta-analysis2024Health Science Reports
Comparing Anticoagulation Strategies for Venous Thromboembolism Associated With Active Cancer: A Systematic Review and Meta-Analysis2024JACC. Cardiooncology
The safety and efficacy of NOACs versus LMWH for thromboprophylaxis after THA or TKA: A systemic review and meta-analysis2024Asian Journal of Surgery
Safety outcomes of direct oral anticoagulants in older adults with atrial fibrillation: a systematic review and meta-analysis of (subgroup analyses from) randomized controlled trials2024Geroscience
Anticoagulant drugs for patients with atrial fibrillation on dialysis: a systematic analysis and network meta-analysis2023Frontiers in Pharmacology
Effectiveness and safety of edoxaban versus warfarin in patients with nonvalvular atrial fibrillation: a systematic review and meta-analysis of observational studies2023Frontiers in Pharmacology
Efficacy and Safety of Direct Oral Anticoagulants for Stroke Prevention in Older Patients With Atrial Fibrillation: A Network Meta-Analysis of Randomized Controlled Trials2023Journal of the American Heart Association
Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of deep vein thrombosis2023The Cochrane Database of Systematic Reviews
Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of pulmonary embolism2023The Cochrane Database of Systematic Reviews
Effects of direct oral anticoagulants vs. vitamin K antagonists on acute kidney injury in patients with atrial fibrillation: A systematic review2023Frontiers in Cardiovascular Medicine
Efficacy and Safety of Renal Function on Edoxaban Versus Warfarin for Atrial Fibrillation: A Systematic Review and Meta-Analysis2023Medicines (Basel, Switzerland)
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 trials2023European Heart Journal
Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Systematic Review of Economic Evaluations2023Value in Health Regional Issues
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 trials2023Orthopaedics & Traumatology, Surgery & Research
Optimal stroke preventive strategy for patients aged 80 years or older with atrial fibrillation: a systematic review with traditional and network meta-analysis2022Age and Ageing
Effects of oral anticoagulant therapy in patients with pulmonary diseases2022Frontiers in Cardiovascular Medicine
Efficacy and Safety of Oral Anticoagulants for Atrial Fibrillation Patients With Chronic Kidney Disease: A Systematic Review and Meta-Analysis2022Frontiers in Cardiovascular Medicine
Comparative Risks of Fracture Among Direct Oral Anticoagulants and Warfarin: A Systematic Review and Network Meta-Analysis2022Frontiers in Cardiovascular Medicine
The use of non-vitamin K oral anticoagulants in dialysis patients-A systematic review2022Seminars in Dialysis
Population Pharmacokinetic Models for Direct Oral Anticoagulants: A Systematic Review and Clinical Appraisal Using Exposure Simulation2022Clinical Pharmacology and therapeutics
Direct oral anticoagulation in atrial fibrillation and heart valve surgery-a meta-analysis and systematic review2022Therapeutic Advances in Cardiovascular Disease
Comparative Safety and Efficacy of Eight Antithrombotic Regimens for Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention2022Frontiers in Cardiovascular Medicine
Real-world evidence comparing oral anticoagulants in non-valvular atrial fibrillation: a systematic review and network meta-analysis2022Future Cardiology
Reappraisal of Non-vitamin K Antagonist Oral Anticoagulants in Atrial Fibrillation Patients: A Systematic Review and Meta-Analysis2021Frontiers in Cardiovascular Medicine
Effectiveness of Direct Oral Anticoagulants in Obese Adults With Atrial Fibrillation: A Systematic Review of Systematic Reviews and Meta-Analysis2021Frontiers in Cardiovascular Medicine
Use of NOACs Versus Vitamin K Antagonist in Atrial Fibrillation Catheter Ablation: An Updated Meta-analysis With Subgroup Analysis2021American Journal of Therapeutics
The risk of gastrointestinal hemorrhage with non-vitamin K antagonist oral anticoagulants: A network meta-analysis2021Medicine
Direct oral anticoagulants in treatment of cerebral venous thrombosis: a systematic review2021BMJ Open
The efficacy and safety of edoxaban versus warfarin in preventing clinical events in atrial fibrillation: A systematic review and meta-analysis2021Anatolian Journal of Cardiology
The association of fracture risk in atrial fibrillation patients and long-term anticoagulant therapy category: a systematic review and meta-analysis2021PeerJ
A network meta-analysis of non-vitamin K antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and diabetes mellitus2021Acta Cardiologica
Twice- or Once-Daily Dosing of Direct Oral Anticoagulants, a systematic review and meta-analysis2021Thrombosis Research
The Risk of Gastrointestinal Bleeding between Non-Vitamin K Antagonist Oral Anticoagulants and Vitamin K Antagonists in the Asian Atrial Fibrillation Patients: A Meta-Analysis2020International Journal of Environmental Research and Public Health
Net Clinical Benefit of Direct Oral Anticoagulants in Patients With Cancer and Venous Thromboembolism: A Systematic Review and Trade-Off Analysis2020Frontiers in Cardiovascular Medicine
Diagnosis and Treatment of Lower Extremity Venous Thromboembolism: A Review2020JAMA
Safety and efficacy of dual versus triple antithrombotic therapy (DAT vs TAT) in patients with atrial fibrillation following a PCI: a systematic review and network meta-analysis2020BMJ Open
Efficacy and safety of non-vitamin K anticoagulants and warfarin in patients with atrial fibrillation and heart failure: A network meta-analysis2020Thrombosis Research
The risk of bleeding and all-cause mortality with edoxaban versus vitamin K antagonists: A meta-analysis of phase III randomized controlled trials2020Thrombosis Research
The role of non-vitamin K antagonist oral anticoagulants in Asian patients with atrial fibrillation: A PRISMA-compliant article2020Medicine
Safety and Efficacy of Oral Anticoagulants Therapies in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A Network Meta-Analysis2020Journal of Cardiovascular Pharmacology and Therapeutics
Meta-analysis of efficacy and safety of new oral anticoagulants compared with warfarin in Japanese patients undergoing catheter ablation for atrial fibrillation2020Journal of interventional Cardiac Electrophysiology
Efficacy and Safety of Non-Vitamin K Anticoagulants for Atrial Fibrillation in Relation to Different Renal Function Levels: A Network Meta-Analysis2020Cardiovascular Therapeutics
Direct Oral Anticoagulants for the Treatment of Acute Venous Thromboembolism Associated with Cancer: A Systematic Review and Meta-Analysis2020Thrombosis and Haemostasis
Efficacy and Safety of Direct Oral Anticoagulants in Elderly Patients With Atrial Fibrillation: A Network Meta-Analysis2020Frontiers in Medicine
Comparative efficacy and safety of warfarin care bundles and novel oral anticoagulants in patients with atrial fibrillation: a systematic review and network meta-analysis2020Scientific Reports
Meta-analysis of Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention2020The American Journal of Cardiology
Non-vitamin K antagonist oral anticoagulants in Asian patients with atrial fibrillation: evidences from the real-world data2020Heart Failure Reviews
Comparative Clinical Outcomes of Edoxaban in Adults With Nonvalvular Atrial Fibrillation2020American Journal of therapeutics

Clinical Practice Guidelines

Document TitleYearSource
Practical guide for anticoagulant and antiplatelet reversal in clinical practice2023Pharmacy
2021 European Heart Rhythm Association practical guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation2021Europace
The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society comprehensive guidelines for the management of atrial fibrillation2020Canadian 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 syndromes2020European Heart Journal
Venous thromboembolic diseases: diagnosis, management and thrombophilia testing2020NICE
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 update2020Journal of Clinical Oncology
SBA 2020: Regional anesthesia guideline for using anticoagulants update2020Brazilian 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 Surgeons2019Circulation