betrixaban and Venous-Thrombosis

betrixaban has been researched along with Venous-Thrombosis* in 11 studies

Reviews

2 review(s) available for betrixaban and Venous-Thrombosis

ArticleYear
Prevention of Venous Thromboembolism in Acutely Ill Medical Patients: A New Era.
    Seminars in respiratory and critical care medicine, 2021, Volume: 42, Issue:2

    Venous thromboembolism (VTE) is the leading preventable cause of death in hospitalized patients and data consistently show that acutely ill medical patients remain at increased risk for VTE-related morbidity and mortality in the post-hospital discharge period. Prescribing extended thromboprophylaxis for up to 45 days following an acute hospitalization in key patient subgroups that include more than one-quarter of hospitalized medically-ill patients represents a paradigm shift in the way hospital-based physicians think about VTE prevention. Advances in the field of primary thromboprophylaxis in acutely-ill medical patients using validated VTE and bleeding risk assessment models have established key patient subgroups at high risk of VTE and low risk of bleeding that may benefit from both in-hospital and extended thromboprophylaxis. The direct oral anticoagulants betrixaban and rivaroxaban are now U.S. Food and Drug Administration-approved for in-hospital and extended thromboprophylaxis in medically ill patients and provide net clinical benefit in these key subgroups. Coronavirus disease-2019 may predispose patients to VTE due to excessive inflammation, platelet activation, endothelial dysfunction, and hemostasis. The optimum preventive strategy for these patients requires further investigation. This article aims to review the latest concepts in predicting and preventing VTE and discuss the new era of extended thromboprophylaxis in hospitalized medically ill patients.

    Topics: Anticoagulants; Benzamides; COVID-19; Critical Care; Decision Support Systems, Clinical; Duration of Therapy; Hospitalization; Humans; Medical Informatics; Patient Discharge; Pulmonary Embolism; Pyridines; Risk Assessment; Rivaroxaban; SARS-CoV-2; Venous Thromboembolism; Venous Thrombosis

2021
Venous thromboembolism prevention through the use of novel Factor Xa inhibitors.
    Postgraduate medicine, 2019, Volume: 131, Issue:2

    The risk of a venous thromboembolic event is not limited to the pre-hospital, hospital, or immediate post-hospital period. Because of challenges with data collection, the risk of venous thromboembolism (VTE) up to 3 months post-hospitalization for patients with acute and serious medical problems in the setting of chronic disease and/or risk factors for VTE is probably under reported. The growing acceptance and indications of direct oral anticoagulants (DOACs) now includes an indication for VTE prevention for one of the Factor Xa agents. In this paper, the authors explore the issue of VTE in the extended post-hospital period and strategies to provide protection from these morbid and potentially mortal events with oral anticoagulants.

    Topics: Benzamides; Factor Xa Inhibitors; Hemorrhage; Hospitalization; Humans; Patient Discharge; Practice Guidelines as Topic; Pulmonary Embolism; Pyridines; Venous Thromboembolism; Venous Thrombosis

2019

Trials

7 trial(s) available for betrixaban and Venous-Thrombosis

ArticleYear
Extended prophylaxis of venous thromboembolism with betrixaban in acutely ill medical patients with and without cancer: insights from the APEX trial.
    Journal of thrombosis and thrombolysis, 2020, Volume: 49, Issue:2

    Acutely ill medical patients with cancer are at increased risk of venous thromboembolism (VTE). Thromboprophylaxis is recommended in the presence of cancer, but its safety is not known. The aim of this study was to assess the efficacy and safety of extended prophylaxis with betrixaban in cancer patients enrolled in the APEX trial. APEX was a randomized, double-blind trial comparing oral betrixaban 80 mg qd administered for 35-42 days with subcutaneous enoxaparin 40 mg qd administered for 10 ± 4 days. Patients with acute medical illness and a history of cancer or active cancer were eligible for inclusion. Primary efficacy outcome was VTE (composite of symptomatic VTE and asymptomatic proximal deep vein thrombosis); primary safety outcome was major bleeding. Of 7513 patients enrolled in the APEX trial, 959 patients (12.8%), 499 randomized to betrixaban and 460 to enoxaparin, had cancer. The primary efficacy outcome occurred in 5.7% of cancer patients treated with betrixaban and in 6.2% treated with enoxaparin (p = 0.95). No significant interaction according to the presence or absence of cancer was observed (p = 0.36). Major bleeding events occurred in 0.8% of patients in the betrixaban group and in 0% in the enoxaparin group (p = 0.13), with no significant interaction (p = 0.07). The composite of major and clinically relevant non-major bleeds was similar between the two groups (2.9% and 2.0%, respectively, RR 1.43, 95% CI 0.63-3.27). Betrixaban was similarly effective in the reduction of VTE among subjects with and without cancer. The incidence of major bleeding was similarly low.

    Topics: Acute Disease; Aged; Aged, 80 and over; Benzamides; Critical Illness; Double-Blind Method; Drug Administration Schedule; Factor Xa Inhibitors; Female; Hemorrhage; Humans; Male; Neoplasms; Post-Exposure Prophylaxis; Pyridines; Venous Thrombosis

2020
Asymptomatic Deep Vein Thrombosis is Associated with an Increased Risk of Death: Insights from the APEX Trial.
    Thrombosis and haemostasis, 2018, Volume: 118, Issue:12

     Asymptomatic deep vein thrombosis (DVT) diagnosed with compression ultrasound (CUS) is a common endpoint in trials assessing the efficacy of anticoagulants to prevent venous thromboembolism (VTE), but the relationship of asymptomatic thrombus to mortality remains uncertain..  In the APEX trial (ClinicalTrials.gov: NCT01583218), 7,513 acutely ill hospitalized medical patients were randomly assigned to extended-duration betrixaban (35-42 days) or enoxaparin (10 ± 4 days). Asymptomatic DVT was assessed once with CUS between day 32 and 47, and mortality was assessed through 77 days..  Asymptomatic DVT was associated with approximately threefold increased risk of short-term all-cause mortality in patients hospitalized with an acute medical illness within the prior 77 days. A positive linear trend was observed between greater thrombus burden and mortality during the follow-up.

    Topics: Aged; Aged, 80 and over; Anticoagulants; Asymptomatic Diseases; Benzamides; Enoxaparin; Female; Humans; Male; Proportional Hazards Models; Pyridines; Risk; Survival Analysis; United States; Venous Thromboembolism; Venous Thrombosis

2018
Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy.
    Pharmaceutical statistics, 2017, Volume: 16, Issue:6

    Competing risk methods are time-to-event analyses that account for fatal and/or nonfatal events that may potentially alter or prevent a subject from experiencing the primary endpoint. Competing risk methods may provide a more accurate and less biased estimate of the incidence of an outcome but are rarely applied in cardiology trials. APEX investigated the efficacy of extended-duration betrixaban versus standard-duration enoxaparin to prevent a composite of symptomatic deep-vein thrombosis (proximal or distal), nonfatal pulmonary embolism, or venous thromboembolism (VTE)-related death in acute medically ill patients (n = 7513). The aim of the current analysis was to determine the efficacy of betrixaban vs standard-duration enoxaparin accounting for non-VTE-related deaths using the Fine and Gray method for competing risks. The proportion of non-VTE-related death was similar in both the betrixaban (133, 3.6%) and enoxaparin (136, 3.7%) arms, P = .85. Both the traditional Kaplan-Meier method and the Fine and Gray method accounting for non-VTE-related death as a competing risk showed equal reduction of VTE events when comparing betrixaban to enoxaparin (HR/SHR = 0.65, 95% 0.42-0.99, P = 0.046). Due to the similar proportion of non-VTE-related deaths in both treatment arms and the use of a univariate model, the Fine and Gray method provided identical results to the traditional Cox model. Using the Fine and Gray method in addition to the traditional Cox proportional hazards method can indicate whether the presence of a competing risk, which is dependent of the outcome, altered the risk estimate.

    Topics: Aged; Anticoagulants; Benzamides; Delayed-Action Preparations; Double-Blind Method; Enoxaparin; Factor Xa Inhibitors; Humans; Kaplan-Meier Estimate; Models, Statistical; Proportional Hazards Models; Pulmonary Embolism; Pyridines; Research Design; Risk; Risk Assessment; Venous Thromboembolism; Venous Thrombosis

2017
N-terminal pro-B-type natriuretic peptide and the risk of stroke among patients hospitalized with acute heart failure: an APEX trial substudy.
    Journal of thrombosis and thrombolysis, 2017, Volume: 44, Issue:4

    Among patients hospitalized with acute heart failure (HF), the prognostic value of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in short-term stroke prediction remains unclear.. In the APEX trial, 7513 patients hospitalized for an acute medical illness were randomized to receive either extended-duration betrixaban (80 mg once daily for 35-42 days) or standard-of-care enoxaparin (40 mg once daily for 10 ± 4 days) for venous thromboprophylaxis. Baseline NT-proBNP concentrations were obtained in 3261 patients admitted for HF. Stroke events were adjudicated by an independent clinical events committee blinded to thromboprophylaxis allocation. The association of NT-proBNP level and other risk factors and biomarkers with stroke was assessed at 77 days after randomization.. Baseline NT-proBNP concentration was associated with short-term stroke among patients hospitalized with acute HF. Stroke risk assessment models should consider incorporation of NT-proBNP measurement.

    Topics: Acute Disease; Aged; Aged, 80 and over; Benzamides; Enoxaparin; Female; Heart Failure; Hospitalization; Humans; Male; Natriuretic Peptide, Brain; Peptide Fragments; Pyridines; Risk Assessment; Stroke; Venous Thrombosis

2017
Thrombus Burden of Deep Vein Thrombosis and Its Association with Thromboprophylaxis and D-Dimer Measurement: Insights from the APEX Trial.
    Thrombosis and haemostasis, 2017, Volume: 117, Issue:12

    Background The aim of this study was to evaluate the effect of betrixaban on the occurrence of deep vein thrombosis (DVT) and also the extent of thrombus and to assess the association of baseline D-dimer with subsequent thrombus burden.\ \ Methods In the APEX trial (ClinicalTrials.gov: NCT01583218), 7,513 acutely ill hospitalized medical patients were randomly assigned to extended-duration betrixaban (35–42 days) or enoxaparin (10 ± 4 days). D-dimer concentration was measured at baseline, and mandatory lower-extremity compression ultrasonography (CUS) was performed at 35 to 42 days. The thrombus burden of DVT was assessed by the number of non-compressible vascular segments in six target proximal veins and compared between treatment groups and D-dimer categories (≥2 × upper limit of normal [ULN] versus <2 × ULN).\ \ Results Compared with enoxaparin, extended-duration betrixaban reduced the DVT risk at 35 to 42 days (any-dose: relative risk [RR] = 0.76 [95% confidence interval: 0.61–0.94]; p = 0.013; full-dose: RR = 0.70 [0.55–0.90]; p = 0.005). Patients who received betrixaban were more likely to have a lower thrombus burden (p = 0.012 for any-dose and p = 0.001 for full-dose). Elevated D-dimer at baseline was independently associated with a 2.12-fold increased risk of developing DVT (p < 0.001). A greater thrombus burden was also observed in those with D-dimer ≥ 2 × ULN compared with <2 × ULN (p < 0.0001).\ \ Conclusion Extended-duration betrixaban reduced the number of venous segments with thrombosis at 35 to 42 days compared with enoxaparin. A positive D-dimer was associated with a greater extent of thrombus burden among acutely ill medical patients who developed DVT despite receiving thromboprophylaxis.

    Topics: Aged; Aged, 80 and over; Anticoagulants; Benzamides; Enoxaparin; Factor Xa Inhibitors; Female; Fibrin Fibrinogen Degradation Products; Humans; Lower Extremity; Male; Pyridines; Risk; Ultrasonography; Veins; Venous Thrombosis

2017
The safety and efficacy of full- versus reduced-dose betrixaban in the Acute Medically Ill VTE (Venous Thromboembolism) Prevention With Extended-Duration Betrixaban (APEX) trial.
    American heart journal, 2017, Volume: 185

    The APEX trial assessed the safety and efficacy of extended-duration thromboprophylaxis using betrixaban versus standard dosing of enoxaparin among hospitalized, acutely ill medical patients. The 80-mg betrixaban dose was halved to 40 mg among subjects with severe renal insufficiency and those receiving a concomitant strong P-glycoprotein inhibitor.. This analysis assessed the pharmacokinetics, efficacy, and safety of full- (80 mg) and reduced-dose (40 mg) betrixaban relative to enoxaparin in the APEX trial.. The median concentration of betrixaban among subjects administered the 80-mg dose was higher than that of the 40-mg dose (19 ng/mL vs 11 ng/mL, P<.001). In the primary analysis cohort 1 (d-dimer ≥2× upper limit of normal), the primary efficacy outcome (asymptomatic proximal deep vein thrombosis, symptomatic proximal or distal deep vein thrombosis, symptomatic nonfatal pulmonary embolism, or venous thromboembolism-related death) was significantly reduced among subjects treated with 80 mg of extended-duration betrixaban versus enoxaparin (6.27% [95/1516] vs 8.39% [130/1549], relative risk reduction=0.26 [0.04-0.42], P=.023), and similarly in the entire primary efficacy outcome population (4.87% [122/2506] vs 7.06% [181/2562], relative risk reduction=0.30 [0.13-0.44], P=.001). There was no difference in the primary outcome for subjects treated with 40 mg betrixaban vs enoxaparin across cohorts. In addition, there was no excess of major bleeding associated with either betrixaban dose compared with enoxaparin.. The 80-mg betrixaban dose achieves higher plasma concentrations than the 40-mg dose and, in contrast to the 40-mg dose, is associated with improved efficacy across all cohorts relative to standard-dose enoxaparin without an excess risk of major bleeding in the management of medically ill subjects.

    Topics: Aged; Aged, 80 and over; Anticoagulants; Benzamides; Double-Blind Method; Enoxaparin; Factor Xa Inhibitors; Female; Hemorrhage; Hospitalization; Humans; Male; Pulmonary Embolism; Pyridines; Venous Thromboembolism; Venous Thrombosis

2017
Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients.
    The New England journal of medicine, 2016, 08-11, Volume: 375, Issue:6

    Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown.. Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding.. A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55).. Among acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218.).

    Topics: Acute Disease; Adult; Aged; Benzamides; Double-Blind Method; Drug Administration Schedule; Factor Xa Inhibitors; Female; Fibrin Fibrinogen Degradation Products; Hemorrhage; Hospitalization; Humans; Male; Middle Aged; Pulmonary Embolism; Pyridines; Risk Factors; Ultrasonography; Venous Thromboembolism; Venous Thrombosis

2016

Other Studies

2 other study(ies) available for betrixaban and Venous-Thrombosis

ArticleYear
Extended Thromboprophylaxis for Medical Patients.
    The American journal of medicine, 2020, Volume: 133, Issue:1

    Topics: Aftercare; Anticoagulants; Benzamides; Duration of Therapy; Enoxaparin; Heparin, Low-Molecular-Weight; Hospitalization; Humans; Length of Stay; Pulmonary Embolism; Pyrazoles; Pyridines; Pyridones; Rivaroxaban; Venous Thromboembolism; Venous Thrombosis

2020
Design, synthesis and biological evaluation of anthranilamide derivatives as potential factor Xa (fXa) inhibitors.
    Bioorganic & medicinal chemistry, 2018, 12-15, Volume: 26, Issue:23-24

    Factor Xa (fXa) is a crucial player in various thromboembolic disorders. Inhibition of fXa can provide safe and effective antithrombotic effects. In this study, a series of anthranilamide compounds were designed by utilizing structure-based design strategies. Optimization at P1 and P4 groups led to the discovery of compound 16g: a highly potent, selective fXa inhibitor with pronounced in vitro anticoagulant activity. Moreover, 16g also displayed excellent in vivo antithrombotic activity in the rat venous thrombosis (VT) and arteriovenous shunt (AV-SHUNT) models. The bleeding risk evaluation showed that 16g had a safer profile than that of betrixaban at 1 mg/kg and 5 mg/kg dose. Additionally, 16g also exhibited satisfactory PK profiles. Eventually, 16g was selected to investigate its effect on hypoxia-reoxygenation- induced H9C2 cell viability. MTT results showed that H9C2 cell viability can be remarkably alleviated by 16g.

    Topics: Animals; Anticoagulants; Arteriovenous Shunt, Surgical; Cell Survival; Disease Models, Animal; Dose-Response Relationship, Drug; Drug Design; Factor Xa; Molecular Docking Simulation; Molecular Structure; ortho-Aminobenzoates; Rats; Structure-Activity Relationship; Venous Thrombosis

2018
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