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Andexanet alfa

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https://www.readbyqxmd.com/read/29703468/antidotes-for-the-direct-oral-anticoagulants-what-news
#1
S Galliazzo, M P Donadini, W Ageno
The direct oral anticoagulants (DOACs) are recommended as the first-choice anticoagulants for both stroke prevention in patients with non-valvular atrial fibrillation and the treatment and secondary prevention of venous thromboembolism. DOACs cause bleeding, albeit less than warfarin. Most bleeding complications can be controlled by general reversal strategies and supportive care. However, in case of life-threatening bleeding, or when urgent invasive procedures are needed, a more rapid and thorough reversal may be required...
April 2018: Thrombosis Research
https://www.readbyqxmd.com/read/29687299/anticoagulation-reversal-in-vitamin-k-antagonist-associated-intracerebral-hemorrhage-a-systematic-review
#2
Darae Ko, Zayd Razouki, James Otis, Erika Marulanda-Londoño, Elaine M Hylek
The effect of rapid anticoagulation reversal on mortality and functional outcome in vitamin K antagonist-associated intracerebral hemorrhage (VKA-ICH) is uncertain. Given the approval of idarucizumab for dabigatran reversal and pending approval for andexanet alfa for reversal of factor Xa inhibitors, a systematic appraisal of the effectiveness of reversal for VKA-ICH would provide a bench mark for current practice. We performed PubMed searches and reviewed current guidelines. Using pre-specified inclusion and exclusion criteria, studies were reviewed by two physicians independently...
April 23, 2018: Journal of Thrombosis and Thrombolysis
https://www.readbyqxmd.com/read/29590221/andexanet-alfa-effectively-reverses-edoxaban-anticoagulation-effects-and-associated-bleeding-in-a-rabbit-acute-hemorrhage-model
#3
Genmin Lu, Polly Pine, Janet M Leeds, Francis DeGuzman, Pratikhya Pratikhya, Joyce Lin, John Malinowski, Stanley J Hollenbach, John T Curnutte, Pamela B Conley
INTRODUCTION: Increasing use of factor Xa (FXa) inhibitors necessitates effective reversal agents to manage bleeding. Andexanet alfa, a novel modified recombinant human FXa, rapidly reverses the anticoagulation effects of direct and indirect FXa inhibitors. OBJECTIVE: To evaluate the ability of andexanet to reverse anticoagulation in vitro and reduce bleeding in rabbits administered edoxaban. MATERIALS AND METHODS: In vitro studies characterized the interaction of andexanet with edoxaban and its ability to reverse edoxaban-mediated anti-FXa activity...
2018: PloS One
https://www.readbyqxmd.com/read/29569500/mechanisms-of-action-and-clinical-use-of-specific-reversal-agents-for-non-vitamin-k-antagonist-oral-anticoagulants
#4
Kristoffer Andresen, Dan Atar, Erik Gjertsen, Waleed Ghanima, Svein Roseth, Odd Erik Johansen
OBJECTIVES: With a steadily growing number of patients with non-valvular atrial fibrillation, anticoagulation use increases. Anticoagulation therapy is associated with increased risk of serious bleeding and an increased complexity in management of patients in need for urgent surgery. We wanted to assess the magnitude of this challenge as well as review current and potential future clinical management strategies. DESIGN: A review of the literature on the magnitude of patients using antigoaculants in potential need for acute restoration of hemostasis was conducted, as well as current status of reversal agents for non-vitamin K antagonist oral anticoagulants (NOACs)...
June 2018: Scandinavian Cardiovascular Journal: SCJ
https://www.readbyqxmd.com/read/29494368/pharmacologic-reversal-of-direct-oral-anticoagulants
#5
Nicholas Farina, James T Miller
Direct oral anticoagulants are becoming increasingly popular in outpatient use. These medications have lacked specific reversal agents. However, this is changing. The Federal Food and Drug Administration approved idarucizumab for reversal of dabigatran in 2016, and another agent, andexanet alfa, is currently in clinical trials for reversal of rivaroxaban and apixaban. This article examines the efficacy and safety of these emerging reversal agents, as well as other historical agents for reversal of direct oral anticoagulants...
April 2018: Critical Care Nursing Quarterly
https://www.readbyqxmd.com/read/29372400/andexanet-alfa-to-reverse-the-anticoagulant-activity-of-factor-xa-inhibitors-a-review-of-design-development-and-potential-place-in-therapy
#6
REVIEW
Michelangelo Sartori, Benilde Cosmi
Direct oral anticoagulants are associated with rates of major bleeding which are not negligible, albeit lower than those associated with vitamin K antagonists. No specific reversal agent for factor Xa (FXa) direct inhibitors is currently available for clinical use. A modified activated human FXa decoy protein, andexanet alfa, is being developed that binds FXa direct inhibitors in their active site, thus reversing their anticoagulant effect. The purpose of this article is to review the design, development and clinical trials of andexanet alfa...
April 2018: Journal of Thrombosis and Thrombolysis
https://www.readbyqxmd.com/read/29345686/reversal-agents-for-non-vitamin-k-antagonist-oral-anticoagulants
#7
REVIEW
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
https://www.readbyqxmd.com/read/29296829/safety-pharmacokinetics-and-reversal-of-apixaban-anticoagulation-with-andexanet-alfa
#8
Deborah Siegal, Genmin Lu, Janet M Leeds, Mark Karbarz, Janice Castillo, Vandana Mathur, Athiwat Hutchaleelaha, Uma Sinha, Michael Kitt, Matt McClure, Stanley J Hollenbach, John T Curnutte, Pamela B Conley, Mark Crowther
Direct factor Xa (FXa) inhibitors lack a specific reversal agent for emergencies such as major bleeding or urgent surgery. Andexanet alfa, a modified, catalytically inactive, recombinant human FXa derivative, reverses anticoagulant effect by binding and sequestering FXa inhibitors. This original report of safety and dose-finding, phase 1 and 2 randomized, double-blind, placebo-controlled studies, investigated various doses of andexanet in healthy volunteers. Phase 1 evaluated the safety and pharmacokinetics of andexanet (n = 24) or placebo (n = 8)...
September 26, 2017: Blood Advances
https://www.readbyqxmd.com/read/29064044/management-of-elective-surgery-and-emergent-bleeding-with-direct-oral-anticoagulants
#9
REVIEW
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
https://www.readbyqxmd.com/read/28979172/reversing-factor-xa-inhibitors-clinical-utility-of-andexanet-alfa
#10
REVIEW
Scott Kaatz, Hardik Bhansali, Joseph Gibbs, Robert Lavender, Charles E Mahan, David G Paje
Approximately half of patients started on an oral anticoagulant in the USA now receive one of the newer direct oral anticoagulants (DOACs). Although there is an approved reversal agent for the direct thrombin inhibitor dabigatran, a specific reversal agent for the anti-factor Xa (FXa) DOACs has yet to be licensed. Unlike the strategy to reverse the only oral direct thrombin inhibitor with idarucizumab, which is a humanized monoclonal antibody fragment, a different approach is necessary to design a single agent that can reverse multiple anti-FXa medications...
2017: Journal of Blood Medicine
https://www.readbyqxmd.com/read/28769570/reversal-of-direct-oral-anticoagulants
#11
REVIEW
Mosaad Almegren
Reversal agents for direct oral anticoagulants (DOACs), including factor X inhibitors and direct thrombin inhibitors, are a major concern in clinical practice. After DOACs were introduced and became widely used as an alternative for vitamin K antagonists in the management of venous thromboembolism and nonvalvular atrial fibrillation, the need for effective reversal agents has increased, particularly for life-threatening bleeding episodes related to DOACs or to reverse medication effects during urgent interventions...
2017: Vascular Health and Risk Management
https://www.readbyqxmd.com/read/28735353/non-vitamin-k-oral-anticoagulants-noacs-and-their-reversal
#12
REVIEW
Sujan T Reddy, T C Cossey, Sean I Savitz, James C Grotta
PURPOSE OF REVIEW: An 80-year-old man presents with an acute right hemiparesis and National Institutes of Health Stroke Scale (NIHSS) of 25, 14 h after taking dabigatran. Activated partial thromboplastin time (aPTT) is 42.8 s. Arteriogram demonstrates left internal carotid artery thrombosis. What is the appropriate management of this patient with acute ischemic stroke while on a NOAC? RECENT FINDINGS: Idarucizumab is a reversal agent approved for dabigatran, and two more reversal agents, andexanet alfa and aripazine, are currently in development for NOACs...
September 2017: Current Neurology and Neuroscience Reports
https://www.readbyqxmd.com/read/28682477/preclinical-safety-and-efficacy-of-andexanet-alfa-in-animal-models
#13
G Lu, S J Hollenbach, D C Baker, S Tan, A Hutchaleelaha, J T Curnutte, P B Conley
Essentials There is currently no approved reversal agent for factor Xa (FXa) inhibitors Andexanet alfa has been developed to reverse the anticoagulant effects of FXa inhibitors Andexanet reduced blood loss and anticoagulation markers in rivaroxaban-anticoagulated rabbits Andexanet was well tolerated in monkeys and rats, with no evidence of prothrombotic activity SUMMARY: Background Andexanet alfa is a recombinant modified form of factor Xa (FXa), designed to bind to and reverse the anticoagulant activity of FXa inhibitors...
September 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28650000/andexanet-alfa-a-recombinant-mimetic-of-human-factor-xa-for-the-reversal-of-anticoagulant-therapies
#14
REVIEW
G Escolar, M Diaz-Ricart, E Arellano-Rodrigo
Activated coagulation factor X (FXa) is a common target for classic and newer anticoagulants. Parenteral anticoagulants with an indirect inhibitory action on FXa (low-molecular-weight heparins) have a well-established clinical efficacy in the prophylaxis and therapy of thromboembolic conditions. More recently developed direct oral anticoagulants (DOACs) have emerged as a new class of antithrombotic drugs. Rivaroxaban, apixaban and edoxaban are direct inhibitors of FXa approved for the management of venous thromboembolism and stroke prevention in atrial fibrillation...
May 2017: Drugs of Today
https://www.readbyqxmd.com/read/28581331/exploring-indications-for-the-use-of-direct-oral-anticoagulants-and-the-associated-risks-of-major-bleeding
#15
Truman J Milling, Jennifer Frontera
Thrombosis is a leading cause of morbidity and mortality in the United States. Arterial and venous thromboses are implicated in the pathogenesis of major disorders, including myocardial infarction, ischemic stroke, and venous thromboembolism. Over the past decade, direct oral anticoagulants (DOACs) (eg, direct thrombin inhibitor and factor Xa [FXa] inhibitors) have been adopted as alternatives to warfarin due to their clinical advantages and efficacy for the treatment of thrombosis. As with all anticoagulants, treatment with DOACs is associated with a risk of major bleeding, including life-threatening gastrointestinal bleeds and intracranial hemorrhages (ICHs)...
April 2017: American Journal of Managed Care
https://www.readbyqxmd.com/read/28509773/perioperative-management-of-antithrombotic-therapies
#16
REVIEW
Timur Yurttas, Patrick M Wanner, Miodrag Filipovic
PURPOSE OF REVIEW: Perioperative coagulation management is becoming increasingly frequent in the daily routine of the anesthesiologist and with the plethora of new substances on the market also increasingly complex. The perioperative setting poses unique challenges requiring an individualized evaluation and management of antithrombotic therapy. This review shall summarize the newest developments in this domain. RECENT FINDINGS: New data in patients with atrial fibrillation have led to a paradigm change in the perioperative management of antithrombotics...
August 2017: Current Opinion in Anaesthesiology
https://www.readbyqxmd.com/read/28429198/managing-the-perioperative-patient-on-direct-oral-anticoagulants
#17
Jordan Leitch, Janet van Vlymen
PURPOSE: Patients are increasingly treated with direct oral anticoagulants (DOACs) for the prevention of stroke due to non-valvular atrial fibrillation and for the treatment of venous thromboembolism. When these patients present for urgent or emergent surgical procedures, they present a challenge to the anesthesiologist who must manage perioperative risk due to anticoagulation. The purpose of this module is to review the literature surrounding the perioperative management of DOACs. Timing, laboratory monitoring, and availability of reversal agents are important considerations to optimize patients being treated with DOACs who require emergent surgery...
June 2017: Canadian Journal of Anaesthesia, Journal Canadien D'anesthésie
https://www.readbyqxmd.com/read/28386620/direct-oral-anticoagulants-doac-management-of-emergency-situations-rationale-and-design-of-the-radoa-registry
#18
Edelgard Lindhoff-Last
The worldwide increase in the aging population and the associated increase in the prevalence of atrial fibrillation and venous thromboembolism as well as the widespread use of direct oral anticoagulants (DOAC) have resulted in an increase of the need for the management of bleeding complications and emergency operations in frail, elderly patients, in clinical practice. When severe bleeding occurs, general assessment should include evaluation of the bleeding site, onset and severity of bleeding, renal function, and concurrent medications with focus on antiplatelet drugs and nonsteroidal anti-inflammatory drugs (NSAID)...
April 6, 2017: Hämostaseologie
https://www.readbyqxmd.com/read/28337750/efficacy-and-safety-of-the-drugs-used-to-reverse-direct-oral-anticoagulants-a-systematic-review-and-meta-analysis
#19
REVIEW
Luis Teodoro da Luz, Mylene Marchand, Bartolomeu Nascimento, Homer Tien, Avery Nathens, Prakesh Shah
BACKGROUND: Direct oral anticoagulants (DOACs) are effective and safe for prophylaxis and treatment of thromboembolic phenomena. However, managing DOACs during bleeding emergencies is challenging. A systematic review and meta-analysis was conducted on studies addressing efficacy and safety of the drugs used for reversal of DOACs. STUDY DESIGN AND METHODS: Medline, Embase, Cochrane Library, and ClinicalTrials.gov were searched up to September 2016. Studies that examined clinical and laboratory effects of drugs used to reverse DOACs were included...
July 2017: Transfusion
https://www.readbyqxmd.com/read/28314985/the-role-of-new-oral-anticoagulants-in-orthopaedics-an-update-of-recent-evidence
#20
REVIEW
Dimitrios V Papadopoulos, Ioannis Kostas-Agnantis, Ioannis Gkiatas, Andreas G Tsantes, Panagiota Ziara, Anastasios V Korompilias
Rivaroxaban, dabigatran, apixaban and edoxaban are the four available new oral anticoagulants (NOAC) which are currently approved for venous thromboembolism prophylaxis after total hip and knee replacement. Large phase 3 and phase 4 studies comparing NOAC with low molecular weight heparins have shown similar results regarding the efficacy and safety of these two categories of anticoagulants. Management of bleeding complications is a matter of great significance. Three reversal agents have been developed: idarucizumab, andexanet alfa and ciraparantag...
July 2017: European Journal of Orthopaedic Surgery & Traumatology: Orthopédie Traumatologie
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