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https://www.readbyqxmd.com/read/28230262/evaluation-of-the-immunogenicity-of-the-dabigatran-reversal-agent-idarucizumab-during-phase-i-studies
#1
Stephen Norris, Steven Ramael, Ippei Ikushima, Wouter Haazen, Akiko Harada, Viktoria Moschetti, Susumu Imazu, Paul A Reilly, Benjamin Lang, Joachim Stangier, Stephan Glund
AIMS: Idarucizumab, a humanized monoclonal anti-dabigatran antibody fragment, is effective in emergency reversal of dabigatran anticoagulation. Pre-existing and treatment-emergent anti-idarucizumab antibodies (antidrug antibodies; ADA) may affect the safety and efficacy of idarucizumab. This analysis characterized the pre-existing and treatment-emergent ADA and assessed their impact on the pharmacokinetics and pharmacodynamics (PK/PD) of idarucizumab. METHODS: Data were pooled from three phase I, randomized, double-blind idarucizumab studies in healthy Caucasian; elderly, renally impaired subjects; and healthy Japanese subjects...
February 23, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28222322/reversal-of-dabigatran-associated-major-bleeding-with-activated-prothrombin-concentrate-a-prospective-cohort-study
#2
Sam Schulman, B Ritchie, S Nahirniak, P L Gross, M Carrier, A Majeed, H-G Hwang, M Zondag
The reversal of dabigatran-associated major bleeding can now be achieved with the antidote idarucizumab. We evaluated activated prothrombin complex concentrate (aPCC) as an alternative for this purpose. Patients treated with dabigatran and suffering a major bleed were treated as per existing hospital protocol with aPCC. They were subsequently recruited for a 30-day follow-up. Effectiveness was evaluated by the treating physician, using an Assessment Guide. Safety outcomes were arterial or venous thromboembolism or death...
February 16, 2017: Thrombosis Research
https://www.readbyqxmd.com/read/28210988/real-life-experience-with-the-specific-reversal-agent-idarucizumab-for-the-management-of-emergency-situations-in-dabigatran-treated-patients-a-series-of-11-cases
#3
Milan R Vosko, Christof Bocksrucker, Rafał Drwiła, Petr Dulíček, Tomas Hauer, Johannes Mutzenbach, Christoph J Schlimp, David Špinler, Thomas Wolf, Daša Zugwitz
Non-vitamin K antagonist oral anticoagulants (NOACs) have a favorable benefit-risk profile compared with vitamin K antagonists. However, the lack of specific reversal agents has made the management of some patients receiving long-term treatment with NOACs problematic in emergency situations such as major bleeding events or urgent procedures. Idarucizumab, a fully humanized Fab antibody fragment that binds specifically and with high affinity to dabigatran, was recently approved for use in adult patients treated with dabigatran when rapid reversal of its anticoagulant effect is required...
February 16, 2017: Journal of Thrombosis and Thrombolysis
https://www.readbyqxmd.com/read/28208197/reversal-of-direct-oral-anticoagulants-current-status-and-future-directions
#4
Jeffrey I Weitz
Direct oral anticoagulants (DOACs) are increasingly used for prevention and treatment of venous thromboembolism and for prevention of stroke in patients with nonvalvular atrial fibrillation. In phase III clinical trials that included more than 100,000 patients, the DOACs were at least as effective as vitamin K antagonists (VKAs) and were associated with less serious bleeding, particularly less intracranial bleeding. Real-world evidence supports these outcomes. Despite this, some physicians and patients are concerned about serious bleeding or emergencies unless specific reversal agents for the DOACs are available...
February 2017: Seminars in Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28184089/anticoagulants-updates-on-idarucizumab
#5
S J Chandan, T Thomas, S H Baryah
No abstract text is available yet for this article.
February 10, 2017: British Dental Journal
https://www.readbyqxmd.com/read/28167634/management-of-patients-on-non-vitamin-k-antagonist-oral-anticoagulants-in-the-acute-care-and-periprocedural-setting-a-scientific-statement-from-the-american-heart-association
#6
Amish N Raval, Joaquin E Cigarroa, Mina K Chung, Larry J Diaz-Sandoval, Deborah Diercks, Jonathan P Piccini, Hee Soo Jung, Jeffrey B Washam, Babu G Welch, Allyson R Zazulia, Sean P Collins
Non-vitamin K oral anticoagulants (NOACs) are now widely used as alternatives to warfarin for stroke prevention in atrial fibrillation and management of venous thromboembolism. In clinical practice, there is still widespread uncertainty on how to manage patients on NOACs who bleed or who are at risk for bleeding. Clinical trial data related to NOAC reversal for bleeding and perioperative management are sparse, and recommendations are largely derived from expert opinion. Knowledge of time of last ingestion of the NOAC and renal function is critical to managing these patients given that laboratory measurement is challenging because of the lack of commercially available assays in the United States...
February 6, 2017: Circulation
https://www.readbyqxmd.com/read/28146465/successful-use-of-idarucizumab-as-a-reversal-agent-for-dabigatran-in-a-patient-with-acute-dissected-aortic-aneurysm
#7
Anna Tomaszuk-Kazberuk, Paulina Łopatowska, Elżbieta Młodawska, Joanne van Ryn, Paul A Reilly, Charles V Pollack
No abstract text is available yet for this article.
January 31, 2017: Polskie Archiwum Medycyny Wewnętrznej
https://www.readbyqxmd.com/read/28144727/-non-vitamin-k-dependent-oral-anticoagulants-what-is-important-in-intensive-care-medicine
#8
D C Gulba, L Broscaru
Since first used in 2009, non-vitamin K oral anticoagulants (NOAC) have gained world-wide acceptance. Two groups of NOAC are currently used: the direct thrombin antagonist dabigatran and three direct factor  Xa antagonists apixaban, edoxaban, and ricaroxaban. With their increasing use for prevention of thromboembolism, the probability increases that NOAC-pretreated patients are admitted to emergency departments or intensive care units.The clinical challenge in NOAC preanticoagulated patients is to adequately cope with the given anticoagulated status of such patients...
January 31, 2017: Medizinische Klinik, Intensivmedizin und Notfallmedizin
https://www.readbyqxmd.com/read/28144725/-noac-real-life-data-and-the-role-of-antidotes-for-the-treatment-of-bleeding
#9
H Darius
The non-vitamin K antagonists (NOAC) are an integral component of our antithrombotic prevention and therapy. For four of the NOAC, their non-inferiority or even superiority versus vitamin K antagonists (VKA) has been proven. Thus, the management of special patient cohorts or the management of active bleeding complications is a focus of current discussion.In addition to prospective trials, numerous retrospective analyses of health insurers or public health provider data have been analyzed and published as "real life" or "real-world evidence" data...
January 31, 2017: Medizinische Klinik, Intensivmedizin und Notfallmedizin
https://www.readbyqxmd.com/read/28110992/idarucizumab-for-the-reversal-of-dabigatran
#10
REVIEW
Michael Gottlieb, Basem Khishfe
No abstract text is available yet for this article.
January 19, 2017: Annals of Emergency Medicine
https://www.readbyqxmd.com/read/28102773/the-optimal-duration-of-anticoagulant-therapy-after-unprovoked-venous-thromboembolism-still-a-challenging-issue
#11
Giovanna Elmi, Giuseppe Di Pasquale, Raffaele Pesavento
As about 50 % of patients with unprovoked venous thromboembolism (VTE) will develop new episodes after discontinuing therapy, indefinite treatment is suggested in patients with low or moderate bleeding risk. Baseline and post-baseline factors can help clinicians to identify patients at high risk of recurrence, who require extended treatment. Residual vein obstruction and D-dimer assay have been shown to be suitable methods for assessing the risk of VTE recurrences after a first unprovoked VTE. In treatment for VTE the use of direct oral anticoagulants (DOAC) is growing instead of the standard adjusted dose of vitamin K antagonists...
January 19, 2017: VASA. Zeitschrift Für Gefässkrankheiten
https://www.readbyqxmd.com/read/28011314/idarucizumab-praxbind%C3%A2-the-first-reversal-agent-for-a-direct-oral-anticoagulant
#12
EDITORIAL
Shannon W Finks, Kelly C Rogers
Idarucizumab is a humanized monoclonal antibody fragment engineered to specifically neutralize the effects of the oral direct thrombin inhibitor dabigatran in order to restore hemostasis. FDA approval for idarucizumab, under the brand name Praxbind®, was granted in October 2015 for the reversal of dabigatran in settings of emergent life-threatening bleeding episodes or in the case when an emergent surgery or urgent procedure is needed to reverse its anticoagulant effects.(1) This article summarizes pertinent and clinical information regarding idarucizumab and other reversal agents currently under investigation...
December 20, 2016: American Journal of Medicine
https://www.readbyqxmd.com/read/27986971/management-of-bleeding-in-patients-receiving-non-vitamin-k-antagonists
#13
REVIEW
Sudarshan Balla, Scott Koerber, Greg Flaker
Anticoagulation with non-vitamin K antagonists (Non vitamin K oral anticoagulant (NOACs)) including dabigatran, rivaroxaban, apixaban and edoxaban is at least as effective as warfarin, has fewer drug and food interactions and does not require monthly monitoring. Although major bleeding with NOACs is infrequent, there remains concern about the ability to effectively treat episodes of major bleeding. New agents have been developed that are capable of providing rapid reversal of the anticoagulation effect of NOACs...
December 16, 2016: Postgraduate Medical Journal
https://www.readbyqxmd.com/read/27981865/healthcare-resource-utilization-in-patients-receiving-idarucizumab-for-reversal-of-dabigatran-anticoagulation-due-to-major-bleeding-urgent-surgery-or-procedural-interventions-interim-results-from-the-re-verse-ad-%C3%A2-study
#14
Charles V Pollack, Richard Bernstein, Robert Dubiel, Paul Reilly, Fredrik Gruenenfelder, Menno V Huisman, Chak-Wah Kam, Eva Kleine, Jerrold H Levy, Frank W Sellke, Thorsten Steiner, Anastasia Ustyugova, Jeffrey I Weitz
AIMS: Patients treated with anticoagulants may experience serious bleeding or require urgent surgery or intervention, and may benefit from rapid anticoagulant reversal. This exploratory analysis assessed healthcare resource utilization (HCRU) in patients treated with idarucizumab, a specific reversal agent for dabigatran etexilate. MATERIALS AND METHODS: RE-VERSE AD(™) (NCT02104947), a prospective, multicenter open-label study is evaluating idarucizumab for dabigatran reversal in patients with serious bleeding (Group A) or undergoing emergency surgery/procedures (Group B)...
December 16, 2016: Journal of Medical Economics
https://www.readbyqxmd.com/read/27920714/idarucizumab-as-antidote-to-intracerebral-hemorrhage-under-treatment-with-dabigatran
#15
Valentin Held, Philipp Eisele, Christoph C Eschenfelder, Kristina Szabo
BACKGROUND AND PURPOSE: Non-vitamin K anticoagulants (NOAC) such as dabigatran have become important therapeutic options for the prevention of stroke. Until recently, there were only nonspecific agents to reverse their anticoagulant effects in a case of emergency. Idarucizumab, an antibody fragment targeting dabigatran, is the first specific antidote for a NOAC to be approved, but real-world experience is limited. METHODS: We report two cases of patients on dabigatran with acute intracerebral hemorrhage who received idarucizumab...
September 2016: Case Reports in Neurology
https://www.readbyqxmd.com/read/27917717/reversal-agents-for-oral-antiplatelet-and-anticoagulant-treatment-during-bleeding-events-current-strategies
#16
Peter Raimondi, Elaine M Hylek, Konstantinos N Aronis
There is an increasing prevalence of cardiovascular diseases that warrant antithrombotic therapy. Antithrombotic therapy includes antiplatelet agents and anticoagulation therapy with vitamin K antagonists (VKAs) or non-Vitamin K oral anticoagulants (NOACs). Antithrombotic therapy is associated with increased rates of bleeding. In this review we summarize the evidence and provide strategies for the management of severe bleeding in the setting of antithrombotic therapy. There is limited data on the management of bleeding in the setting of antiplatelet therapy...
December 5, 2016: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/27913536/reversal-of-direct-oral-anticoagulants-a-practical-approach
#17
Andrew W Shih, Mark A Crowther
Direct oral anticoagulants (DOACs) have at least noninferior efficacy compared with other oral anticoagulants and have ancillary benefits, including overall better safety profiles, lack of the need for routine monitoring, rapid onset of action, and ease of administration. Reversal of these agents may be indicated in certain situations such as severe bleeding and for perioperative management. DOAC-associated bleeding should be risk stratified: patients with moderate or severe bleeding should have the DOAC discontinued and reversal strategies should be considered...
December 2, 2016: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/27904905/idarucizumab-does-not-have-procoagulant-effects-assessment-of-thrombosis-biomarkers-in-healthy-volunteers
#18
Michael Schmohl, Stephan Glund, Akiko Harada, Susumu Imazu, Marina De Smet, Viktoria Moschetti, Steven Ramael, Ippei Ikushima, Fredrik Grünenfelder, Paul Reilly, Joachim Stangier
Idarucizumab, a humanised monoclonal antibody fragment, binds dabigatran with high affinity and immediately, completely and sustainably reverses dabigatran-induced changes on blood coagulation. The present analysis focuses on the evaluation of potential procoagulant properties of idarucizumab when administered in the absence of dabigatran. As part of two Phase I studies conducted in healthy Caucasian and Japanese male volunteers, the effect of idarucizumab (8 g as a 1-hour [h] infusion and 4 g as a 5-minute [min] infusion) and placebo on calibrated automated thrombography (CAT) was assessed using platelet-poor plasma samples...
January 26, 2017: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/27900867/-new-direct-oral-anticoagulants-actual-review
#19
Jana Michalcová, Miroslav Penka, Alena Buliková, Jiřina Zavřelová, Andrea Štěpařová
In recent years the options of anticoagulant/antithrombotic therapy have extended with new - direct oral anticoagulants, comprising direct thrombin inhibitors (dabigatran etexilate) and direct factor Xa inhibitors (rivaroxaban, apixaban). These agents represent another progress towards "the ideal antithrombotic drug", and thus towards a safe and effective antithrombotic therapy. The following article provides actual review and recommendations for clinical practice, including laboratory assessment and management of emergency situations...
2016: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/27895055/role-of-agents-for-reversing-the-effects-of-target-specific-oral-anticoagulants
#20
REVIEW
Tanya R Riley, Mary L Gauthier-Lewis, Chelsea K Sanchez, Janine S Douglas
PURPOSE: The available clinical data on target-specific oral anticoagulant (TSOAC) reversal agents that are currently in development or have been approved by the Food and Drug Administration (FDA) are reviewed. SUMMARY: The development of TSOACs such as dabigatran, rivaroxaban, edoxaban, and apixaban has presented benefits and new challenges. One of the main challenges associated with the use of TSOACs is the lack of suitable agent-specific reversal agents. Several treatment options for the management of life-threatening bleeding events associated with TSOAC use, such as fresh frozen plasma, prothrombin complex concentrates, and recombinant coagulation factor VIIa, have been used, with inconsistent results...
January 15, 2017: American Journal of Health-system Pharmacy: AJHP
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