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Janusz Bednarski, Paweł Balsam, Agata Tymińska, Krzysztof Ozierański, Katarzyna Żukowska, Martyna Zaleska, Katarzyna Szepietowska, Kacper Maciejewski, Michał Peller, Anna Praska-Oginska, Inna Zaboyska, Grzegorz Opolski
INTRODUCTION Atrial fibrillation (AF) is the most common cardiac arrhythmia with a significant risk of morbidity and mortality. Non-vitamin K antagonists (NOAC) are the first line drugs in stroke prevention in AF patients. The oral anticoagulation therapy (OAC) therapy may differ between medical centres. OBJECTIVES The study aimed to compare the clinical characteristic of AF patients treated with OAC between district and academic hospitals. PATIENTS AND METHODS This analysis consisted of 3528 patients from the multicentre, retrospective CRAFT study (NCT02987062): 2666 patients from academic hospital (Group A) and 862 patients from district hospital (Group B)...
March 17, 2018: Polish Archives of Internal Medicine
C M Chavez-Eng, R W Lutz, D Goykhman, K P Bateman
Methodology for analysis of a microdosing drug cocktail designed to evaluate the contribution of drug transporters and drug metabolizing enzymes to disposition was developed using LC-MS based detection. Fast and sensitive methods were developed and qualified for the quantification of statins (pitavastatin, pitavastain lactone, rosuvastatin, atorvastatin, 2-hydroxy, and 4-hydroxy atorvastatin), midazolam, and dabigatran in human plasma. Chromatographic separation was accomplished using reversed phase liquid chromatography or HILIC with gradient elution and detection by MS/MS in the positive ionization mode using electrospray ionization...
March 13, 2018: Journal of Pharmaceutical Sciences
Luke S Howard
Acute pulmonary embolism (PE) is a relatively common cardiopulmonary emergency that is a major cause of hospitalization and morbidity and is the primary cause of mortality associated with venous thromboembolism (VTE). During the last decade, one of the biggest changes in the management of PE has been the approval of four non-vitamin K antagonist oral anticoagulants (NOACs; apixaban, dabigatran, edoxaban and rivaroxaban) for the treatment of PE and deep vein thrombosis and secondary prevention of VTE. Areas covered: This article reviews the evolving management of PE in the NOAC era and addresses three fundamental questions: who should receive NOACs over conventional heparin/vitamin K antagonist regimens for the treatment of acute PE; whether patients should be treated as inpatients or outpatients; and how long patients should be treated to reduce the risk of recurrence? Expert commentary: The management of PE is changing...
March 15, 2018: Expert Review of Respiratory Medicine
Zdeňka Hajšmanová, Pavla Šigutová, Alena Lavičková
Idarucizumab is designed to reverse the anticoagulant effect of dabigatran. This case report describes the administration of three independent doses of idarucizumab to a 76-year-old man suffering from atrial flutter being treated with dabigatran to prevent ischaemic stroke. The last dose of dabigatran was administered in the morning of the same day the patient was transferred to hospital because of the need for urgent pericardium puncture. Baseline dTT (dilute thrombin time) reached 700 ng/mL as glomerular filtration (GF) dropped to 0...
February 2018: Hämostaseologie
Stephan Glund, Guanfa Gan, Viktoria Moschetti, Paul Reilly, Markus Honickel, Oliver Grottke, Joanne Van Ryn
Idarucizumab, a humanized monoclonal antibody fragment (Fab), provides rapid and sustained reversal of dabigatran-mediated anticoagulation. Idarucizumab and dabigatran are mainly eliminated via the kidneys. This analysis aimed to characterize the renal elimination of idarucizumab and investigate the influence of idarucizumab on the pharmacokinetics (PK) of dabigatran and vice versa. Studies were conducted in 5/6 nephrectomized rats, in human volunteers with and without renal impairment, and in a porcine liver trauma model...
January 1, 2018: Clinical and Applied Thrombosis/hemostasis
Sophie Testa, Oriana Paoletti, Cristina Legnani, Claudia Dellanoce, Emilia Antonucci, Benilde Cosmi, Vittorio Pengo, Daniela Poli, Rossella Morandini, Roberto Testa, Armando Tripodi, Gualtiero Palareti
BACKGROUND: Direct oral anticoagulants(DOACs) are administered at fixed dose without need for dose adjustment by lab testing. A high inter-individual variability in the drug blood levels was shown with all DOACs. To evaluate a possible relationship between DOAC C-trough anticoagulant levels and thromboembolic events,565 consecutivenaïve patients withatrial fibrillation (AF), were enrolled in this study performed within the START-Laboratory Registry. METHODS: DOAC specific measurements [diluted thrombin time (dTT) or anti-FIIa calibrated for dabigatran; anti-FXa calibrated for rivaroxaban or apixaban] at C-trough were performed locally at steady state within 15-25 days from starting treatment...
March 12, 2018: Journal of Thrombosis and Haemostasis: JTH
Amihai Rottenstreich, Netanel Zacks, Geffen Kleinstern, Bruria Hirsh Raccah, Batia Roth, Nael Da'as, Yosef Kalish
The role of drug-level monitoring among patients using direct-acting oral anticoagulant (DOAC) is unclear. We aimed to investigate its 'real-life' utilization and effect on clinical management. A review of records of patients who underwent DOAC level testing during 2013-2017. Overall, 212 patients (median age 77 years) underwent 292 DOAC measurements [apixaban (n = 147), rivaroxaban (n = 102), dabigatran (n = 43)]. Monitoring volume increased by 460% during study period. DOAC level testing was performed during routine follow-up in 51 (17...
March 12, 2018: Journal of Thrombosis and Thrombolysis
John Burn, Munir Pirmohamed
About 1.4 British million people are at risk of strokes due to non-valvular atrial fibrillation (AF) necessitating long-term anticoagulation. The vitamin K antagonist, warfarin, has a long half-life and narrow therapeutic range necessitating regular monitoring and is a common cause of iatrogenic hospital admission. Direct-acting oral anticoagulants (DOACs), dabigatran, rivaroxaban, apixaban and edoxaban are not required to have monitoring but are sensitive to changes in renal function and are associated with poorer adherence...
2018: Open Heart
Martijn J Schuemie, George Hripcsak, Patrick B Ryan, David Madigan, Marc A Suchard
Observational healthcare data, such as electronic health records and administrative claims, offer potential to estimate effects of medical products at scale. Observational studies have often been found to be nonreproducible, however, generating conflicting results even when using the same database to answer the same question. One source of discrepancies is error, both random caused by sampling variability and systematic (for example, because of confounding, selection bias, and measurement error). Only random error is typically quantified but converges to zero as databases become larger, whereas systematic error persists independent from sample size and therefore, increases in relative importance...
March 13, 2018: Proceedings of the National Academy of Sciences of the United States of America
Andrew Bromley, Anna Plitt
Venous thromboembolism (VTE), which includes both deep vein thrombosis and pulmonary embolism (PE), is a very common disorder with high risk for recurrence and is associated with significant morbidity and mortality. The non-vitamin K oral anticoagulants (NOACs), which include dabigatran, rivaroxaban, apixaban, and edoxaban, have been shown to be noninferior to conventional anticoagulant therapy for the prevention of recurrent VTE and are associated with more favorable bleeding risk. Evidence from the treatment of VTE with traditional therapy (low molecular weight heparin and vitamin K antagonists) implies that extended or indefinite treatment reduces risk of recurrence...
March 10, 2018: Cardiology and Therapy
Lynn McBain, Anna Kyle
AIM: To assess annual renal function monitoring and clinical indications for use in patients prescribed dabigatran. METHOD: A quality improvement activity included all patients in the Compass Health Primary Health Organisation (PHO) prescribed dabigatran. Information recorded: demographics; indication for use; daily dose; height; weight; serum creatinine; and estimated glomerular filtration rate (eGFR). The first audit occurred during July 2013 - May 2014, the second during May 2014 - October 2016...
March 9, 2018: New Zealand Medical Journal
Jordanne Feldberg, Param Patel, Ashley Farrell, Sylvia Sivarajahkumar, Karen Cameron, Jennifer Ma, Marisa Battistella
Background: There is a lack of clear benefit and a potential risk of bleeding with direct oral anticoagulant (DOAC) use in chronic kidney disease (CKD) and dialysis patients with atrial fibrillation. The objective of this study was to evaluate how treatment with DOACs affects stroke and bleeding outcomes compared with warfarin or aspirin. Methods: We conducted a systematic review of randomized controlled trials, cohort studies and case series, and searched electronic databases from 1946 to 2017...
March 2, 2018: Nephrology, Dialysis, Transplantation
Maja Hellfritzsch, Lotte Rasmussen, Jesper Hallas, Anton Pottegård
INTRODUCTION: Knowledge on adverse effects (AEs) related to non-vitamin K antagonist oral anticoagulants (NOACs) in real-world populations is sparse. OBJECTIVE: Our objective was to identify signals of potential AEs in patients with atrial fibrillation (AF) initiating NOAC treatment using a hypothesis-free screening approach. METHODS: Using the nationwide Danish registries, we identified patients with AF initiating dabigatran, rivaroxaban, or apixaban between 2011 and 2015 (n = 50,627)...
March 1, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Drayton A Hammond, Laura Baumgartner, Craig Cooper, Elisabeth Donahey, Serena A Harris, Jessica M Mercer, Mandy Morris, Mona K Patel, Angela M Plewa-Rusiecki, Alia A Poore, Ryan Szaniawski, Deanna Horner
PURPOSE: To summarize selected meta-analyses and trials related to critical care pharmacotherapy published in 2017. The Critical Care Pharmacotherapy Literature Update (CCPLU) Group screened 32 journals monthly for impactful articles and reviewed 115 during 2017. Two meta-analyses and eight original research trials were reviewed here from those included in the monthly CCPLU. Meta-analyses on early, goal-directed therapy for septic shock and statin therapy for acute respiratory distress syndrome were summarized...
February 26, 2018: Journal of Critical Care
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
Nazarena Cataldo, Valeria Pegoraro, Claudio Ripellino, Valentino Bertasi, Roberta Di Turi, Maurizio Pastorello, Marco Gambera
Riassunto. Il presente studio intende confrontare il rischio di non persistenza e l'utilizzo delle risorse sanitarie nei pazienti con fibrillazione atriale non valvolare (FANV) naïve al trattamento con antagonisti della vitamina K (AVK) o con nuovi anticoagulanti orali (NAO). Partendo dai database amministrativi di cinque ASL italiane, sono stati selezionati e inclusi nello studio tutti i pazienti con almeno una dimissione ospedaliera per FANV dal 2011 al 2014. Tra questi, i nuovi utilizzatori di AVK o NAO nel 2014 sono stati identificati e seguiti a partire dalla data della prima prescrizione al verificarsi di uno qualsiasi dei seguenti eventi: interruzione della terapia superiore a 90 giorni, passaggio o aggiunta di una molecola differente rispetto a quella prescritta alla data indice, morte del paziente, fine del follow-up (dicembre 2015)...
February 2018: Recenti Progressi in Medicina
Kevin Fortier, Deepti Shroff, Uday N Reebye
BACKGROUND: Dabigatran, rivaroxaban, apixaban and edoxaban are approved novel oral anticoagulants (NOACs) as alternatives to Vitamin K antagonists (VKA). Physicians are prescribing an ever-increasing amount these drugs to their patients due to various advantages over existing medications. AIMS: The objective of this review is to provide the dental professional with current literature surrounding the emergence of NOACs, as well as various case studies on the subject, in an effort to guide clinical decision making regarding these medications...
February 28, 2018: Gerodontology
José Francisco Kerr Saraiva
Atrial fibrillation (AF) is an established risk factor for a first or recurrent stroke. Despite proven efficacy in preventing stroke in patients with AF, warfarin is underused, partly due to safety concerns. Recent randomized trials have shown that non-vitamin K antagonist oral anticoagulants (NOACs) such as dabigatran (a direct thrombin inhibitor) and apixaban, edoxaban, and rivaroxaban (factor Xa inhibitors) are not only non-inferior or superior to warfarin but also demonstrate a decreased risk of cerebrovascular bleeding among patients with AF and moderate to high risk of stroke...
February 27, 2018: Cardiology and Therapy
Jackie Pratt, Philip Crispin
OBJECTIVES: To evaluate the dilute Russell viper venom time (DRVVT) for the detection of direct-acting oral anticoagulants (DOACs) and to investigate the effect of DOACS on coagulation assays. METHODS: Patients on DOACs and controls had plasma levels determined by an anti-Xa assay and dilute thrombin clotting time. Levels were correlated with the DRVVT as well as thrombin clotting time (TCT), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, protein C, protein S and antithrombin levels...
February 27, 2018: European Journal of Haematology
Y Hassona, D Malamos, M Shaqman, Z Baqain, C Scully
Direct oral anticoagulants (DOACs) are increasingly used as alternatives to warfarin because of the superior pharmacokinetic properties. Clinical guidelines on the influences of DOACs for dental procedures have emerged, but all of necessity based on low-quality available evidence. Herein, we share our experience with a case series, and propose a protocol regarding the management of dental patients taking DOACs.
March 2018: Oral Diseases
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