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Brandon Cave, Augustus Hough, Paul P Dobesh
Prophylaxis for venous thromboembolism (VTE) in hospitalized acutely ill medical patients is a well-established practice. Despite the increased use of inpatient prophylaxis, the duration of hospitalization is typically shorter than the duration of VTE prophylaxis provided in clinical trials. In addition, VTE events after hospitalization are not unusual, with the majority of events occurring within 30 days of hospital discharge. Therefore, the 30-day time period post discharge has been identified as a stage in which patients are still at high-risk of developing VTE...
March 15, 2018: Pharmacotherapy
Karsten Mh Bruins Slot, Eivind Berge
BACKGROUND: Factor Xa inhibitors and vitamin K antagonists (VKAs) are now recommended in treatment guidelines for preventing stroke and systemic embolic events in people with atrial fibrillation (AF). This is an update of a Cochrane review previously published in 2013. OBJECTIVES: To assess the effectiveness and safety of treatment with factor Xa inhibitors versus VKAs for preventing cerebral or systemic embolic events in people with AF. SEARCH METHODS: We searched the trials registers of the Cochrane Stroke Group and the Cochrane Heart Group (September 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (August 2017), MEDLINE (1950 to April 2017), and Embase (1980 to April 2017)...
March 6, 2018: Cochrane Database of Systematic Reviews
Majed S Al Yami, Sawsan Kurdi, Ivo Abraham
Background: Standard-duration (7-10 days) thromboprophylaxis with low molecular weight heparin, low dose unfractionated heparin, or fondaparinux in hospitalized medically ill patients is associated with ~50% reduction in venous thromboembolism (VTE) risk. However, these patients remain at high risk for VTE post-discharge. The direct oral anticoagulants (DOACs) apixaban, rivaroxaban and betrixaban have been evaluated for extended-duration (30-42 days) thromboprophylaxis in this population...
2018: Journal of Blood Medicine
Danial E Baker
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers...
February 2018: Hospital Pharmacy
Jessica W Skelley, Angela R Thomason, Jeffery C Nolen, PharmD Candidate
Betrixaban (Bevyxxa): a direct-acting oral anti-coagulant factor Xa inhibitor.
February 2018: P & T: a Peer-reviewed Journal for Formulary Management
Jerrold H Levy, James Douketis, Jeffrey I Weitz
The non-vitamin K antagonist oral anticoagulants (NOACs) include dabigatran, which inhibits thrombin, and apixaban, betrixaban, edoxaban, and rivaroxaban, which inhibit coagulation factor Xa. Although clinical studies of NOACs were conducted without antidotes, patient outcomes with major bleeding when receiving NOACs were no worse than those in patients treated with a vitamin K antagonist. Nonetheless, in patients with life-threatening bleeding or requiring urgent surgery, the capacity for rapid NOAC reversal is likely to increase patient safety...
January 18, 2018: Nature Reviews. Cardiology
Scott G Garland, Christina E DeRemer, Steven M Smith, John G Gums
OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of the factor Xa (FXa) inhibitor betrixaban for extended-duration prophylaxis of acute medically ill patients with venous thromboembolism (VTE) risk factors. DATA SOURCES: A MEDLINE/PubMed (January 1990 to October 2017) search was conducted using the following keywords: betrixaban, PRT054021, FXa inhibitor, novel oral anticoagulant, NOAC, direct oral anticoagulant, DOAC, and target specific oral anticoagulant, TSOAC...
January 1, 2018: Annals of Pharmacotherapy
Taylor Steuber
Appropriate treatment of venous thromboembolism (VTE) is critical to minimizing long-term morbidity and mortality. The emergence of direct oral anticoagulants (DOACs) has provided clinicians with expanded therapeutic options for patients with VTE, and as a result, updated practice guidelines released by the American College of Chest Physicians favor DOACs over traditional anticoagulants, such as warfarin. The newest DOAC, betrixaban, received FDA approval in 2017, with an indication for VTE prophylaxis in hospitalized adults...
December 2017: American Journal of Managed Care
Anna Jacobs, Rajesh Kabra, Pranab Das, Carrie S Oliphant
Following publication of our review article 4 years ago, there has been an uptake in the use of nonvitamin K oral antagonists, also known as direct oral anticoagulants. The most recent Xa inhibitors to receive approval are edoxaban, which has been approved for use in both atrial fibrillation and venous thromboembolism prevention and betrixaban, which has been approved in the USA for extended thromboprophylaxis in the medically ill population. Additional analyses of certain types of atrial fibrillation patients have now become available...
January 2018: Future Cardiology
Megan K Yee, Tarek Nafee, Yazan Daaboul, Serge Korjian, Fahad AlKhalfan, Mathieu Kerneis, Cara Wiest, Samuel Z Goldhaber, Adrian F Hernandez, Russell D Hull, Alexander T Cohen, Robert A Harrington, C Michael Gibson
Hospitalized acute medically ill patients with a history of venous thromboembolism (VTE) are at increased risk for recurrent VTE. We characterized the efficacy and safety of betrixaban for prevention of recurrent VTE in these high risk patients. The APEX trial randomized 7513 acutely ill hospitalized medical patients at risk for developing VTE to receive either betrixaban for 35-42 days or enoxaparin for 10 ± 4 days to prevent VTE. This exploratory post-hoc analysis assessed the efficacy and safety of betrixaban versus enoxaparin among subjects with and without prior VTE...
January 2018: Journal of Thrombosis and Thrombolysis
Charles E Mahan, Allison E Burnett, Meghan L Fletcher, Alex C Spyropoulos
Venous thromboembolism (VTE) is a significant healthcare burden with approximately 900,000 events annually in the United States, over half of which are healthcare-associated. This number is anticipated to double by 2050. Group prophylaxis strategies confined to the inpatient setting appear to have minimal impact on the reduction of post-discharge VTE in medically ill patients due to shortened lengths of stay and a heterogenous population that includes patients at low risk for VTE. In accordance with current guideline recommendations, very few (<5%) medically ill patients are discharged with extended prophylaxis, which potentially creates a clinical gap for at-risk patients as VTE risk has been shown to persist for up to 90 days...
February 2018: Hospital Practice (Minneapolis)
G Escolar, M Díaz-Ricart, E Arellano-Rodrigo
Venous thromboembolism (VTE), comprising deep vein thrombosis and pulmonary embolism, is a serious clinical and public health concern. Hospitalization is a major risk factor for developing VTE. Hospital-associated events account for more than 50% of all cases of VTE. Heparins have demonstrated to be efficacious in the prevention of VTE in medically ill patients. Despite the demonstrated efficacy and safety of the available direct oral anticoagulants in the prevention and treatment of different thromboembolic conditions, their net benefit in the prevention of VTE in hospitalized medically ill patients has not been fully confirmed...
August 2017: Drugs of Today
Daniel A Hussar, Bradley Inman
No abstract text is available yet for this article.
November 2017: Journal of the American Pharmacists Association: JAPhA
Scott Kaatz, Charles E Mahan, Asaad Nakhle, Kulothungan Gunasekaran, Mahmoud Ali, Robert Lavender, David G Paje
PURPOSE OF REVIEW: The purpose of this review was to offer practical management strategies for when patients receiving direct oral anticoagulants require elective surgery or present with bleeding complications. RECENT FINDINGS: Clinical practice guidelines are now available on the timing of periprocedural interruption of treatment with the newer direct oral anticoagulants based on their pharmacodynamics and pharmacokinetics and based on findings from cohort studies and clinical trials...
October 24, 2017: Current Cardiology Reports
Kathrin I Foerster, Andrea Huppertz, Oliver J Müller, Timolaos Rizos, Lisa Tilemann, Walter E Haefeli, Jürgen Burhenne
Direct oral anticoagulants (DOACs) are among the most effective options to prevent serious thromboembolic events in patients with atrial fibrillation. Coagulation assays are used to assess DOAC activity, but lack the possibility to quantify drugs with concurrent pharmacodynamic effect. We developed a selective multi-drug assay to analyze apixaban, betrixaban, dabigatran, edoxaban, edoxaban M4, and rivaroxaban with ultra-performance liquid chromatography coupled to tandem mass spectrometry (UPLC/MS/MS) in plasma fulfilling all requirements of the FDA und EMA guidelines for bioanalytical method validation...
October 16, 2017: Journal of Pharmaceutical and Biomedical Analysis
Caitlin M Gibson, Amanda N Basto, Meredith L Howard
OBJECTIVE: Direct oral anticoagulants (DOACs) are recommended for the prevention of stroke or systemic embolism in nonvalvular atrial fibrillation. Dabigatran, rivaroxaban, apixaban, and edoxaban represent possible alternatives to warfarin in the setting of cardioversion. A literature review was conducted to evaluate the safety and efficacy of DOAC use pericardioversion. DATA SOURCES: A PubMed and MEDLINE search through August 2017 was conducted using the following search terms alone or in various combinations: dabigatran, rivaroxaban, apixaban, edoxaban, betrixaban, DOAC, NOAC, TSOAC, cardioversion...
March 2018: Annals of Pharmacotherapy
Gerald Chi, James L Januzzi, Serge Korjian, Yazan Daaboul, Samuel Z Goldhaber, Adrian F Hernandez, Russell D Hull, Alex Gold, Alexander T Cohen, Robert A Harrington, C Michael Gibson
BACKGROUND: 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. METHODS: 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...
November 2017: Journal of Thrombosis and Thrombolysis
Douglas F Arbetter, Purva Jain, Megan K Yee, Nathan Michalak, Adrian F Hernandez, Russell D Hull, Samuel Z Goldhaber, Robert A Harrington, Alex Gold, Alexander T Cohen, C Michael Gibson
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)...
August 24, 2017: Pharmaceutical Statistics
Walter Ageno
Betrixaban is a direct factor Xa inhibitor with a renal excretion of only approximately 5-7%. On June 23rd 2017, it became the first direct oral anticoagulant to receive Food and Drug Administration approval for the prevention of venous thromboembolism in acutely ill medical patients, and the first anticoagulant agent to be approved for extended-duration thromboprophylaxis after hospital discharge in this setting. Approval followed the results of the APEX trial, a phase III clinical trial comparing betrixaban (80 mg) administered for 35-42 days with enoxaparin (40 mg) administered for 10 ± 4 days...
August 14, 2017: Internal and Emergency Medicine
Zhen Wang, Jia Zheng, Yongqiang Zhao, Yungai Xiang, Xiao Chen, Yi Jin
BACKGROUND/AIMS: Venous thromboembolism (VTE) is the most common complication after major joint surgery. VTE can easily develop into pulmonary embolism (PE), leading to cardiopulmonary dysfunction or sudden death. We aimed to comprehensively analyse the thromboprophylactic drugs that are used to prevent thrombosis and reduce bleeding risk. METHODS: We searched the PubMed, EMBASE, and Cochrane databases for randomized controlled trials that evaluated the use of thromboprophylaxis after major joint surgery...
2017: Cellular Physiology and Biochemistry
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