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https://www.readbyqxmd.com/read/28337750/efficacy-and-safety-of-the-drugs-used-to-reverse-direct-oral-anticoagulants-a-systematic-review-and-meta-analysis
#1
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...
March 24, 2017: Transfusion
https://www.readbyqxmd.com/read/28335637/reversing-the-anticoagulation-effects-of-dabigatran
#2
William E Dager, Linda Banares
The standard of care for oral anticoagulation therapy has primarily been warfarin, which is limited by its indirect mechanism-of-action, variable kinetics, tolerability, and routine monitoring concerns. The direct-acting oral anticoagulants (DOACs) have predictable pharmacokinetics and pharmacodynamics, and improved safety and efficacy compared to warfarin for the prevention of stroke in patients with nonvalvular atrial fibrillation and prevention or management of venous thromboembolism. Consequential bleeding is a concern with all anticoagulants...
March 24, 2017: Hospital Practice (Minneapolis)
https://www.readbyqxmd.com/read/28314985/the-role-of-new-oral-anticoagulants-in-orthopaedics-an-update-of-recent-evidence
#3
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...
March 17, 2017: European Journal of Orthopaedic Surgery & Traumatology: Orthopédie Traumatologie
https://www.readbyqxmd.com/read/28290913/-modern-approaches-to-prevention-of-thromboembolic-complications-in-patients-with-nonvalvular-atrial-fibrillation-with-a-direct-thrombin-inhibitor-dabigatran
#4
N M Savina
of recently completed clinical studies and preliminary results of still ongoing studies that support safety and efficacy of dabigatran in patients with nonvalvular atrial fibrillation are under discussion in this article. Currently available data on clinical use of a specific dabigatran antidote idarucizumab are also presented.
July 2016: Kardiologiia
https://www.readbyqxmd.com/read/28270004/-the-first-use-of-iv-idarucizumab-for-dabigatran-reversal-in-hungary
#5
Lajos Driesz, Éva Barabás, Ildikó Bodócs, Zoltán Szántó, György Herr, Gábor Bencsik, László Pál, József Borbola
At present, the direct thrombin inhibitor dabigatran is the only one amongst the new direct anticoagulants which has an effective, specific reversal agent. The novel agent idarucizumab is a humanized, monoclonal antibody fragment binds to dabigatran within minutes thereby offers an opportunity to induce a safe, long-lasting reverse of the anticoagulant effects of dabigatran. The authors describe the first use of idarucizumab in Hungary (23. 05. 2016) in an old female patient with non-valvular paroxysmal atrial fibrillation of high stroke risk-score and renal dysfunction who was taking dabigatran (2 x 110 mg/day) when an acute abdomen developed requiring emergency cholecystectomy...
March 2017: Orvosi Hetilap
https://www.readbyqxmd.com/read/28265404/real-world-use-of-idarucizumab-for-dabigatran-reversal-in-three-cases-of-serious-bleeding
#6
Nicolas Gendron, Anne Laure Feral-Pierssens, Igor Jurcisin, Emmanuelle de Raucourt, Valerie Bouton, Anne Marie Fischer, Camille Lorenceau-Savale, Agnès Lillo-Le Louët, David M Smadja
Bleeding is a rare complication of direct oral anticoagulant potentially associated with high mortality rates. Biological monitoring is necessary for more than 24 h after idarucizumab antidote therapy in case of bleeding with dabigatran therapy.
March 2017: Clinical Case Reports
https://www.readbyqxmd.com/read/28230262/evaluation-of-the-immunogenicity-of-the-dabigatran-reversal-agent-idarucizumab-during-phase-i-studies
#7
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
#8
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
#9
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...
April 2017: Journal of Thrombosis and Thrombolysis
https://www.readbyqxmd.com/read/28208197/reversal-of-direct-oral-anticoagulants-current-status-and-future-directions
#10
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
#11
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
#12
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
#13
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: Pol Arch Intern Med
https://www.readbyqxmd.com/read/28144727/-non-vitamin-k-dependent-oral-anticoagulants-what-is-important-in-intensive-care-medicine
#14
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
#15
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...
March 2017: Medizinische Klinik, Intensivmedizin und Notfallmedizin
https://www.readbyqxmd.com/read/28110992/idarucizumab-for-the-reversal-of-dabigatran
#16
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
#17
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
#18
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
#19
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
#20
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, multi-center open-label study, is evaluating idarucizumab for dabigatran reversal in patients with serious bleeding (Group A) or undergoing emergency surgery/procedures (Group B)...
January 17, 2017: Journal of Medical Economics
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