Savaysa (edoxaban) / Daiichi Sankyo - LARVOL DELTA

HCT-VTE-J Model to Predict Late-Onset Venous Thromboembolism after Allogeneic Hematopoietic Stem Cell Transplantation: A Japanese Single-Center Study. (PubMed, Transplant Cell Ther) - "We characterized the unique clinical presentation and treatment outcomes of VTE in survivors of allo-HSCT. The developed HCT-VTE-J model enables individualized risk stratification, highlighting the importance of GVHD. Although external validation is warranted, these findings may inform targeted surveillance and thromboprophylaxis strategies."

Journal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Cardiovascular • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Disorders • Immunology • Transplantation • Venous Thromboembolism

Anticoagulant stewardship: an opportunity for community pharmacy. (PubMed, Int J Pharm Pract) - "There is increased scope for community pharmacists to be involved more formally in anticoagulant stewardship activities."

Journal

Adding Antiplatelet During Edoxaban Treatment in Stroke Patients With Non-valvular Atrial Fibrillation (ADD-ON) (clinicaltrials.gov) - P=N/A | N=1200 | Active, not recruiting | Sponsor: Asan Medical Center | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2024 ➔ Jun 2026 | Trial primary completion date: Aug 2023 ➔ Jun 2025

Enrollment closed • Trial completion date • Trial primary completion date • Atherosclerosis • Atrial Fibrillation • Cardiovascular • Coronary Artery Disease • Ischemic stroke

Signal mining for non-bleeding adverse event in novel oral anticoagulants: a pharmacovigilance study based on FAERS database. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "For example, dabigatran is associated with adverse reactions including incarcerated inguinal hernia strangulated, macular fibrosis, potassium imbalance, acidosis, and mental status changes. For apixaban, there is a need for caution due to potential adverse reactions including visual impairment, benign prostatic hyperplasia, thyroid disorders, and sleep disturbances. Concerning edoxaban, practitioners should be vigilant about potential adverse effects such as lymphatic disorder, dysuria, diplopia, rash morbilliform, and delirium. Additionally, rivaroxaban may lead to complications such as thrombocytosis, alopecia, prostatic varices, menstrual irregularities, adrenomegaly, and organic brain syndrome. This study has found that the non-bleeding adverse events associated with NOACs are linked to multiple organ systems, which requires high vigilance in clinical practice, especially for some easily overlooked systems such as the reproductive system and breast disorders,..."

Adverse events • Journal • Alopecia • Benign Prostatic Hyperplasia • CNS Disorders • Endocrine Disorders • Fibrosis • Gastroenterology • Genetic Disorders • Hematological Disorders • Immunology • Mental Retardation • Metabolic Disorders • Perinatal Disorders • Psychiatry • Sleep Disorder • Thrombocytosis • Women's Health

Acute Spontaneous Spinal Epidural Hematoma in a Patient on a Direct Oral Anticoagulant (DOAC): A Case Report. (PubMed, Cureus) - "We report the case of a 75-year-old male with atrial fibrillation on Edoxaban who awoke with neck pain and, approximately 80 minutes later, developed sudden right-sided weakness...This case underscores the importance of considering SSEH in anticoagulated patients with acute neck pain and hemiparesis, even when initial imaging for stroke or CAD is negative. Timely MRI and a multidisciplinary approach are crucial to avoid misdiagnosis and optimize outcomes."

Journal • Atrial Fibrillation • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Hypertension • Musculoskeletal Pain • Pain

Impact of thrombocytopenia in patients with cancer-associated isolated distal deep vein thrombosis treated with edoxaban for 12 months versus 3 months: Insights from the ONCO DVT study. (PubMed, Thromb Res) - No abstract available

Journal • Cardiovascular • Hematological Disorders • Oncology • Thrombocytopenia • Thrombosis • Venous Thromboembolism

Risk of bleeding with dentoalveolar surgery in patients taking direct oral anticoagulants or vitamin K antagonists: A systematic review and meta-analysis. (PubMed, Jpn Dent Sci Rev) - "This difference is mainly observed in dabigatran etexilate, while it remains unclear in rivaroxaban, apixaban, and edoxaban. Current quality of evidence is very low, which should be interpreted with caution. Future studies with higher quality of evidence are required to strengthen the validity of these findings."

Journal • Retrospective data • Review

Renal function and long-term outcomes in edoxaban-treated patients: A subanalysis from ETNA-AF Europe 4 years follow up (ESC-WCC 2025) - No abstract available

Clinical • Atrial Fibrillation • Cardiovascular

Bleeding risk using non-steroidal anti-inflammatory drugs in anticoagulated patients with atrial fibrillation: a nationwide cohort study. (PubMed, Eur Heart J Qual Care Clin Outcomes) - "NSAID use was associated with a nearly two-fold increase in hospital-diagnosed bleeding among patients with AF receiving oral anticoagulation. The risk appeared highest with edoxaban, followed by apixaban and rivaroxaban, and lowest with dabigatran and warfarin. The risk was not restricted to the gastrointestinal tract."

Journal • Atrial Fibrillation • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders

Major Bleeding Risk During Concomitant Use of Antiarrhythmic Drugs and Oral Factor Xa Inhibitors: A Nationwide Self-Controlled Case Series Study. (PubMed, Thromb Haemost) - "Concomitant use of FXa inhibitors with amiodarone, diltiazem, or verapamil was related to an increased incidence of major bleeding, particularly during the first month of co-administration. Close monitoring during this period may be warranted for patients at high risk of bleeding."

Journal

Oral anticoagulants-related bleeding: what happens in the emergency room? The Galeno study. (PubMed, Intern Emerg Med) - "Excessive doses were administered to 10.8%, 13%, 18%, and 19% of patients treated with rivaroxaban, edoxaban, apixaban, and dabigatran, respectively. Overall, 25.8% of patients, treated primarily with DOACs, were discharged. The management of oral anticoagulant-related major or life-threatening bleeding in the ER appears poor."

Journal • Hematological Disorders

Comparative clinical outcomes of acenocoumarol versus direct oral anticoagulants (DOACs) and warfarin in patients with atrial fibrillation: real-world-evidence (SIESTA-A study). (PubMed, Front Pharmacol) - "The aim of this study was to evaluate the effectiveness and safety of direct oral anticoagulants (DOACs: dabigatran, rivaroxaban, apixaban and edoxaban) and warfarin versus acenocoumarol in patients with atrial fibrillation under real-world clinical practice conditions. Although DOACs were clearly associated with a lower risk of intracranial bleeding compared to acenocoumarol, our data did not reveal a significant reduction in thromboembolic events. Warfarin was found to be both less effective and less safe than acenocoumarol."

Clinical data • HEOR • Journal • Real-world evidence • Atrial Fibrillation • Cardiovascular • Gastroenterology • Ischemic stroke • Pulmonary Embolism • Respiratory Diseases

Real life application of the ESMO Guidelines for the prevention and treatment of cancer associated thrombosis: challenges and perspectives. (PubMed, Pol Arch Intern Med) - "Treatment of CAT favors low-molecular-weight heparin or direct oral anti-Xa agents (apixaban, edoxaban, rivaroxaban), with incidental venous thromboembolism managed similarly to symptomatic events. Implementation remains suboptimal. Closing the gap demands national strategies promoting health-provider training, patient empowerment, e-health applications, equitable access, and dedicated CAT out-patients clinics for sustained, personalized care."

Journal • Cardiovascular • Colon Cancer • Colorectal Cancer • Hematological Disorders • Oncology • Ovarian Cancer • Renal Disease • Solid Tumor • Thrombocytopenia • Thrombosis • Venous Thromboembolism

Long-term real-world outcomes of edoxaban in atrial fibrillation patients with and without prior ischaemic stroke: A 4-year follow-up analysis from ETNA-AF Europe (ESC-WCC 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Atrial Fibrillation • Cardiovascular • Ischemic stroke

Practical Comprehensive Approach to Current Atrial Fibrillation Challenges: Insights from an Expert Panel. (PubMed, J Clin Med) - "Discrepancy (9%) and rejection (13%) were also reported. This study underscores the importance of a 12-lead electrocardiogram to diagnose AF, with wearable devices serving as useful tools; catheter ablation as a superior strategy for restoring and maintaining sinus rhythm compared to pharmacotherapy; the importance of comorbidity management to reduce incidence and recurrence of AF; adherence and persistence as critical factors for the efficacy and safety of anticoagulation; and the preference for DOACs, particularly apixaban and edoxaban, for stroke prevention in patients ≥75 years old or with chronic kidney disease."

Journal • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

A Clinical Trial to Evaluate the Effect of Grapefruit Juice on the PK/PD of Edoxaban (clinicaltrials.gov) - P1 | N=14 | Not yet recruiting | Sponsor: Hyewon Chung

New P1 trial

VICTORIE: Anticoagulation in Patients With Venous Thromboembolism and Cancer (clinicaltrials.gov) - P=N/A | N=1 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Aug 2025 ➔ Dec 2025

Trial completion date • Cardiovascular • Oncology • Venous Thromboembolism

Edoxaban Steady-State PK/PD in Adults With Nephrotic Syndrome (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: Peking University People's Hospital

New trial • Glomerulonephritis • Nephrology • Renal Disease

Structural Equation Modelling of Nucleotide polymorphisms and Pharmacokinetics in Direct Oral Anticoagulant Use for Stroke and Embolism Prevention in Atrial Fibrillation. (PubMed, Eur J Pharmacol) - "genetics significantly influences DOAC pharmacokinetics, particularly for dabigatran and apixaban, where stroke and bleeding risks correlate with Cmin and Cmax. Pharmacogenomic profiling and therapeutic drug monitoring are crucial for optimizing therapy, especially in high-risk patients."

Journal • PK/PD data • Atrial Fibrillation • Cardiovascular • ABCB1 • ABCG2 • CYP3A4

A case of anticoagulation-related nephropathy complicated by IgA nephropathy that developed following the long-term use of anticoagulants. (PubMed, CEN Case Rep) - "The risk of ARN associated with direct oral anticoagulant agents (DOACs) is lower than that for warfarin, but there have been reports of ARN induced by DOACs other than dabigatran, such as edoxaban. ARN can develop at any time in association with any DOAC, even in patients with normal renal function, and may be associated with anticoagulant overdose and subclinical IgA nephropathy. Therefore, careful monitoring of renal function and urinalysis is necessary for the prevention and early recognition of ARN, and dose reduction or a change in anticoagulant should occur when anticoagulant overdose or ARN is suspected."

Journal • Acute Kidney Injury • Atherosclerosis • Atrial Fibrillation • Cardiovascular • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Prospective Multicenter Clinical Study of Edoxaban in Multiple Myeloma Patients with Venous Thromboembolism (ChiCTR) - P4 | N=100 | Recruiting | Sponsor: Beijing Jishuitan Hospital, Capital Medical University; Beijing Jishuitan Hospital, Capital Medical University

New P4 trial • Cardiovascular • Hematological Malignancies • Multiple Myeloma • Oncology • Venous Thromboembolism

Effects of edoxaban, rivaroxaban, and warfarin on recanalisation, inflammation, and post-thrombotic syndrome in patients with deep vein thrombosis. (PubMed, Cardiovasc J Afr) - "Treatment of DVT is a dynamic process which requires the exact evaluation of the patients according to the several parameters. Recanalised flow, inflammation and situations related to inflammation such as PTS can be used for the assessment. Drugs can be shifted according to the response."

Clinical • Journal • Cardiovascular • Hematological Disorders • Inflammation • Thrombosis • Venous Thromboembolism

Evaluation of International Council for Standardization in Haematology Recommendations on Activated Partial Thromboplastin Time Mixing Tests Using an Automated Haemostasis Analyser. (PubMed, Int J Lab Hematol) - "When using lupus-insensitive reagents, APTT-mixing tests are of limited value in discriminating between factor deficiencies, lupus anticoagulants, or inhibitors. Incubated mixing tests are essential when diagnosing a FVIII-inhibitor. Rather than perform mixing tests, it is better to be guided by clinical presentation and perform further investigations as appropriate, including analysis of anti-Xa activity for the presence of a direct factor-Xa inhibiting anticoagulant, factor assays in patients with bleeding (or with suspected acquired haemophilia A), and lupus anticoagulant assays in patients with no bleeding."

Journal • Hematological Disorders • Hemophilia • Hemophilia A • Immunology • Inflammatory Arthritis • Rare Diseases

D-dimer after 3 months of anticoagulation therapy and outcomes in cancer-associated isolated distal deep vein thrombosis. (PubMed, Blood Vessel Thromb Hemost) - P4 | "There was no significant increased risk of major bleeding in the 12-month edoxaban group relative to the 3-month edoxaban group regardless of the D-dimer levels at 3 months. This trial was registered at www.clinicaltrials.gov as #NCT03895502."

Journal • Cardiovascular • Hematological Disorders • Oncology • Thrombosis • Venous Thromboembolism

Edoxaban-induced enterocolitis: The first case report demonstrating distinct endoscopic and histological features. (PubMed, DEN Open) - "Further case reports and studies are needed to establish DOAC-induced enteritis as a distinct clinical entity. This case serves as a critical first step in recognizing DOAC-induced enterocolitis and highlights the need for increased awareness among clinicians."

Journal • Anorexia • Atrial Fibrillation • Cardiovascular • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hodgkin Lymphoma • Immunology • Inflammation • Inflammatory Bowel Disease • Venous Thromboembolism