dabigatran etexilate / Generic mfg. - LARVOL DELTA

Is there a role for anticoagulation with dabigatran in S. aureus bacteremia? Protocol for the adjunctive treatment domain of the Staphylococcus aureus Network Adaptive Platform (SNAP) randomised controlled trial. (PubMed, BMJ Open) - P4 | "Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. The trial is registered at clinicaltrials.gov with the identifier NCT06650501. NCT0665050."

Clinical protocol • Journal • Atrial Fibrillation • Cardiovascular • Infectious Disease • Venous Thromboembolism

Real-world comparative bleeding outcomes of direct oral anticoagulants versus warfarin in adults: Insights from observational evidence (ASH 2025) - "Background: Direct oral anticoagulants (DOACs) – apixaban, rivaroxaban, dabigatran, and edoxaban– are increasingly preferred over warfarin for stroke prevention in atrial fibrillation and treatment of venous thromboembolism. This review provides robust real-world evidence that DOACs offer a superior safety and effectiveness profile compared to warfarin in adult patients requiring anticoagulation. DOACs significantly reduce the incidence of ICH and stroke– two of the most clinically devasting complications– while maintaining comparable or lower rates of major and GI bleeding. These findings validate guideline recommendations and strongly support the preferential use of DOACs as the standard of care for anticoagulation in everyday clinical practice."

Clinical • Real-world • Real-world evidence • Atrial Fibrillation • Cerebral Hemorrhage • CNS Disorders • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Venous Thromboembolism

Avatrombopag: Beyond the technical sheet - a single-center experience (ASH 2025) - "Avatrombopag was initiated at 20 mg/day, increasing platelet counts to 40–90000/ml, enabling safe initiation of Dabigatran Etexilato. These encouraging observations underscore the need for prospective, controlled studies to validate the efficacy and safety of Avatrombopag in these off-label settings and to better define its role in personalized thrombocytopenia management. Ongoing real-world evidence is essential to inform the evolution of treatment guidelines"

Clinical • Atrial Fibrillation • Cardiovascular • Diabetes • Fibrosis • Hematological Disorders • Hemophilia • Hemophilia A • Hepatology • Hypertension • Immune Thrombocytopenic Purpura • Immunology • Metabolic Disorders • Portal Hypertension • Rare Diseases • Thrombocytopenia • Thrombocytopenic Purpura • Type 2 Diabetes Mellitus

Risk of bleeding in chronic lymphocytic leukemia patients in remission treated with covalent Bruton tyrosine kinase inhibitors and contemporary anticoagulant or antiplatelet drugs: Real-world data analysis (ASH 2025) - "The study population was divided into two main cohorts: 1) Cohort 1: CLLpatients in remission treated with covalent BTKi (ibrutinib/acalabrutinib/zanubrutinib) concurrentlytreated with AC (rivaroxaban/apixaban/edoxaban/dabigatran) or AP agents (acetylsalicylicacid/clopidogrel/prasugrel/ticagrelor/ticlopidin), and 2) Cohort 2: CLL patients in remission treated withcovalent BTKi (ibrutinib/acalabrutinib/zanubrutinib) not concurrently treated with AC or AP agents.Cohort 1 was further subdivided into two groups: those treated only with AC and those treated only withAP. CLL patients in remission treated with covalent BTKis experience a significant risk ofbleeding events. This risk is substantially elevated when covalent BTKis therapy is combined with eitheranticoagulant or antiplatelet agents. Notably, our findings indicate no discernible difference in bleedingrisk between AC or AP agents when used concurrently with covalent BTKis."

Clinical • Real-world • Real-world evidence • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia

Outcomes and resource utilization during and after oral anticoagulant-related bleeding in chronic kidney disease (ORACLE-CKD): A population-based cohort study (ASH 2025) - "We accrued patients ≥66 years who were hospitalized for bleedingand had an OAC (apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin) dispensed precedingadmission (April 2012 to March 2022). Patients hospitalized with OAC-related bleeding are at high risk of death during andimmediately following hospitalization. Mortality risk was greater among patients with CKD. Within 1 yearof hospital discharge, three-quarters of patients with moderate or severe CKD visited the ED, and overhalf were readmitted to hospital."

Clinical • HEOR • Alzheimer's Disease • Atrial Fibrillation • Chronic Kidney Disease • CNS Disorders • Congestive Heart Failure • Dementia • Gastroenterology • Heart Failure • Ischemic stroke • Myocardial Infarction • Nephrology • Renal Disease • Respiratory Diseases • Venous Thromboembolism

Comparative safety and effectiveness of direct oral anticoagulants and low-molecular weight heparin in patients with venous thromboembolism and cancer in europe (ASH 2025) - "ResultsBefore IPTW, we identified 34,687 LMWH users, 3,045 apixaban users, 4,537 rivaroxaban users, 145dabigatran users, and 580 edoxaban users across the five countries. Comparative assessment of rVTE was notpossible due to low event numbers. These findings contribute to the limited body of real-world evidencesupporting the use of DOACs over LMWH for treating patients with VTE and cancer."

Clinical • Cerebral Hemorrhage • CNS Disorders • Oncology • Venous Thromboembolism

Direct Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Global Synthesis of Randomized Evidence through Network Meta-Analysis. (PubMed, Indian Heart J) - "DOACs, particularly apixaban and dabigatran, showed superior efficacy and safety compared with VKAs, with apixaban emerging as the most favourable overall option. However, these findings are derived from indirect rather than direct head-to-head comparisons among DOACs and VKAs and should therefore be interpreted with caution."

Journal • Retrospective data • Review • Atrial Fibrillation • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Ischemic stroke

A UK-wide analysis of 2265 patients receiving a reversal agent for direct oral anticoagulant-associated bleeding. (PubMed, J Thromb Haemost) - "Reversal agents were generally used in patients with clinical evidence of major bleeding but were administered long after the last anticoagulant dose. In gastrointestinal bleeding, andexanet alfa was associated with a higher thrombotic risk than PCC."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Gastroenterology • Hematological Disorders • Thrombosis

A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects (clinicaltrials.gov) - P1 | N=65 | Completed | Sponsor: Lumosa Therapeutics Co., Ltd. | Recruiting ➔ Completed

Trial completion • Cardiovascular • Ischemic stroke

Occurrence of Platelet-Monocyte Aggregates in Patients with Metabolic Disorders and Effect of Direct Anticoagulants. (PubMed, Thromb Haemost) - "Subsequently, blood samples were treated with four direct anticoagulants (rivaroxaban, apixaban, dabigatran, or argatroban, all at a final concentration of 1 µM), and PMA were again detected. Significant correlations of AP and PMA with anthropological and biochemical parameters were found solely in some groups of patients or in some anticoagulant-treated samples. Only argatroban and apixaban-treated samples significantly decreased PMA occurrence, and this was observed solely in the dyslipidemia patient group.These findings suggest a potential positive outcome of anticoagulant treatment for metabolic disease patients and confirm PMA as a sensitive marker in patients with metabolic diseases."

Journal • Cardiovascular • Diabetes • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus • DMRT1

Switching From Aspirin Monotherapy After Noncardioembolic Stroke: A Systematic Review and Network Meta-Analysis. (PubMed, Stroke) - "In the network meta-analysis, dabigatran, apixaban, and aspirin+low-dose rivaroxaban ranked the highest among antithrombotic alternatives to aspirin, though none were significantly better than continuing aspirin. Among patients experiencing ischemic stroke while taking aspirin, switching to an alternative antithrombotic therapy was not conclusively associated with a reduction in recurrent stroke and composite cardiovascular events. Trials are needed to determine whether specific antithrombotic strategies meaningfully improve outcomes in this high-risk population."

Journal • Monotherapy • Retrospective data • Cardiovascular • Ischemic stroke • Myocardial Infarction

DAME study: Dabigatran versus apixaban effect on heavy menstrual bleeding (HMB) evaluation in women of childbearing age (ANZCTR) - P4 | N=660 | Not yet recruiting | Sponsor: Te Whatu Ora/Health New Zealand

New P4 trial • Cardiovascular • Gynecology • Venous Thromboembolism

Dabigatran-idarucizumab pharmacokinetics-pharmacodynamics in sheep undergoing cardiopulmonary bypass. (PubMed, Perfusion) - "A competitive interaction model adequately described dabigatran reversal by idarucizumab. These data and consequent parameter estimates inform future clinical studies in both animals and humans."

Journal • PK/PD data

Giant Thrombus on the Left Atrial Posterior Wall Following Pulsed-Field and Radiofrequency Ablation. (PubMed, JACC Case Rep) - "This case report highlights that pulsed-field ablation with radiofrequency ablation of the LAPW can rarely lead to a giant LAPW thrombus in patients with persistent AF, severe left ventricular dysfunction, and an enlarged LA with a reduced LA-emptying fraction, and intensified oral anticoagulation may be necessary to manage the postablation thrombus."

Journal • Atrial Fibrillation • Cardiomyopathy • Cardiovascular • Heart Failure • Thrombosis

Cognitive Safety and Outcomes of Pharmacological Management in Heart Failure: A Systematic Review. (PubMed, Pharmaceuticals (Basel)) - "In HF populations, sacubitril/valsartan showed no adverse cognitive effects versus other RAAS inhibitors...Comparisons of anticoagulants (dabigatran vs. warfarin; warfarin vs. aspirin) revealed no differences in cognitive trajectories, while optimized medical therapy was associated with parallel improvements in cognitive scores, left ventricular function, and renal parameters...Optimized medical therapy may even support cognitive improvement alongside cardiac and renal recovery. Routine cognitive assessment should be integrated into HF care to support individualized management."

Journal • Review • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Congestive Heart Failure • Dementia • Heart Failure

Detrimental Effect of Plasma From Patients With Severe Aortic Stenosis on Valvular Endothelial Cells: Role of Proinflammatory Cytokines and Factor Xa. (PubMed, J Am Heart Assoc) - "Patients with AS displayed subclinical systemic inflammation and increased FXa activity. These processes contributed to aortic VEC dysfunction, inflammation, monocytes and platelets adhesion, and thrombin generation upon exposure to AS+ plasma."

Journal • Cardiovascular • Hematological Disorders • Inflammation • Oncology • Thrombosis • IL1B • IL6 • TNFA

Dicloxacillin and flucloxacillin inhibit hepatic uptake transporters - in vitro investigations and physiologically based pharmacokinetic modelling. (PubMed, bioRxiv) - "PBPK model simulations predicted no major change in rosuvastatin, a substrate for OATPs and BCRP, pharmacokinetics, when co-administered with dicloxacillin or flucloxacillin. Simulations with dicloxacillin and P-gp substrates dabigatran or digoxin also predicted limited inhibition of P-gp transport."

Journal • PK/PD data • Preclinical • Breast Cancer • Oncology • Solid Tumor • SLCO2B1

Impact of direct oral anticoagulants on blood-brain barrier integrity. (PubMed, IBRO Neurosci Rep) - "In the co-culture model, a significant TEER reduction was observed in the 10 μM dabigatran group, while no significant differences were found for apixaban or rivaroxaban. These preliminary findings suggest that apixaban may help preserve BBB integrity, while dabigatran at certain concentrations may compromise it."

Journal • Cardiovascular • CNS Disorders • Hematological Disorders

Translation of a physiologically-based pharmacokinetic model for dabigatran etexilate to the design of a safety and efficacy study in post-partum women. (PubMed, Br J Clin Pharmacol) - "An integrated PBPK/PD model for dabigatran etexilate in post-partum women has been developed successfully. The model was used to design a future clinical trial examining safety and efficacy of dabigatran in postpartum women at risk of thromboembolism."

Journal • PK/PD data • Cardiovascular

Multifunctional nanoagonist enhances photodynamic therapy-driven in situ cancer vaccination by inhibiting tumor thrombosis. (PubMed, J Nanobiotechnology) - "cDVPMA was constructed by encapsulating the stimulator of interferon genes (STING) agonist 2'3'-cGAMP in the aqueous core of a tertiary ammonium group-containing polymersome, while embedding both the photosensitizer verteporfin-phospholipid (VL) and thrombin inhibitor dabigatran etexilate within the hydrophobic layer. In a 4T1 mouse breast cancer model, cDVPMA combined with near-infrared (NIR) laser irradiation elicited robust antitumor immunity, significantly suppressing primary tumor growth and metastasis, while establishing durable immune memory that prevented tumor recurrence. This study provides valuable insights into the development of nanomedicines for immunotherapy targeting tumors in a hypercoagulable state."

Journal • Breast Cancer • Cardiovascular • Hematological Disorders • Oncology • Solid Tumor • Thrombosis • STING

Perioperative Opioid Prescriptions in Patients on Oral Anticoagulants Undergoing Elective Soft Tissue Hand Surgery. (PubMed, J Hand Surg Am) - "Preoperative oral anticoagulant use was associated with an increased incidence of perioperative opioid prescriptions in patients undergoing elective soft tissue hand surgery."

Journal • Pain

Dabigatran prevents lipopolysaccharide mediated apoptosis in zebrafish through a thrombin independent mechanism. (PubMed, bioRxiv) - "In summary, we identify several novel small molecules that prevent LPS-induced endotoxemia and show that one such small molecule, dabigatran, exerts a thrombin-independent effect on nitric oxide production and apoptosis. This and the other identified small molecules warrant further exploration in inflammatory conditions including sepsis."

Journal • Infectious Disease • Inflammation • Septic Shock

Dabigatran-based versus warfarin-based triple antithrombotic regimen with a 1-month intensification after coronary stenting in patients with nonvalvular atrial fibrillation (COACH-AF PCI). (PubMed, BMC Med) - P4 | "Among AF patients underwent PCI, the dabigatran-based TAT regimen did not significantly reduce the rate of BARC types 2-5 bleeding at 6 months compared with warfarin-based regimen, although the power of the study to find a difference was low due to early termination (COACH-PCI, NCT03536611, https://clinicaltrials.gov/show/NCT03536611 )."

Clinical • Journal • Atrial Fibrillation • Cardiovascular • Infectious Disease • Novel Coronavirus Disease

A Study to Learn If the Study Medicine Called PF-08049820 Changes How the Body Processes the Other Study Medicines Called Oral Contraceptives, Midazolam, and Dabigatran in Healthy Adult Female Participants (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Emergency Reversal of Antithrombotics in Intracerebral Hemorrhage: An Update. (PubMed, Curr Neurol Neurosci Rep) - "Current data suggests reversal of vitamin K antagonists with intravenous vitamin K and 4-factor prothrombin complex concentrates (4f-PCC), reversal of dabigatran with idarucizumab, and reversal or direct oral factor Xa inhibitors with either 4f-PCC or andexanet-alfa. While platelet transfusion is not suggested for antiplatelet-associated ICH, DDAVP may be reasonable, and a new reversal agent is under development for ticagrelor. Rapid reversal of antithrombotic-associated coagulopathy in the context of ICH may prevent ICH expansion and improve neurological outcomes."

Journal • Review • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders