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https://www.readbyqxmd.com/read/28537000/advances-in-clinical-cardiology-2016-a-summary-of-the-key-clinical-trials
#1
REVIEW
Alastair Gray, Conor McQuillan, Ian B A Menown
INTRODUCTION: The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. METHODS: The authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA)...
May 23, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28535438/determination-of-edoxaban-equivalent-concentrations-in-human-plasma-by-an-automated-anti-factor-xa-chromogenic-assay
#2
Ling He, Jarema Kochan, Min Lin, Alexander Vandell, Karen Brown, Francois Depasse
INTRODUCTION: This phase I, open-label, multiple-dose, two-treatment study assessed the relationship between edoxaban equivalent concentration derived from an anti-FXa assay with the summed concentration of edoxaban and its active metabolite, M-4, as assessed by liquid chromatography coupled with tandem mass spectrometry (LC/MS/MS). This study also assessed the relationship between edoxaban plasma concentrations assessed by LC/MS/MS in sodium citrate and lithium heparin tubes. MATERIALS AND METHODS: Healthy volunteers were randomized to receive once-daily edoxaban 60mg or 90mg for 5days (15 participants per treatment group)...
May 7, 2017: Thrombosis Research
https://www.readbyqxmd.com/read/28512699/an-open-label-crossover-study-of-the-pharmacokinetics-of-the-60-mg-edoxaban-tablet-crushed-and-administered-either-by-a-nasogastric-tube-or-in-apple-puree-in-healthy-adults
#3
Kenneth Duchin, Anil Duggal, George J Atiee, Motonori Kidokoro, Tadanobu Takatani, Nicole Lazarus Shipitofsky, Ling He, George Zhang, Tarundeep Kakkar
BACKGROUND: Edoxaban is an orally active, direct factor Xa inhibitor indicated to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation and for the treatment of venous thromboembolism. OBJECTIVES: This study assessed the pharmacokinetics, safety, and tolerability of the edoxaban 60-mg tablet crushed and administered via a nasogastric tube in a water suspension or orally mixed in apple puree. METHODS: This phase 1, open-label, crossover study randomized 30 healthy adults to receive three edoxaban treatment regimens (oral 60-mg edoxaban tablet, or 60-mg edoxaban tablet crushed and administered via a nasogastric tube or orally in apple puree) in one of six treatment sequences...
May 17, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28508916/direct-oral-anticoagulants-for-the-treatment-of-cancer-associated-venous-thromboembolism-what-do-we-know-so-far
#4
Minna Voigtlaender, Florian Langer
Cancer patients with venous thromboembolism (VTE) are at increased risk for both bleeding and VTE recurrence. Anticoagulation with low-molecular-weight heparin (LMWH) is the standard of care during the initial and long-term treatment phase (i.e. during the first 3 - 6 months of therapy) based on its overall beneficial safety and efficacy profile compared to vitamin K antagonists (VKAs). The direct oral anticoagulants (DOACs) rivaroxaban, apixaban, edoxaban, and dabigatran are approved for the treatment of acute VTE, and the combined six phase-3 trials have included > 1500 patients with active cancer, as defined by variable selection criteria...
May 16, 2017: Hämostaseologie
https://www.readbyqxmd.com/read/28496931/safety-of-the-direct-oral-anticoagulant-edoxaban-for-atrial-fibrillation-after-cardiac-surgery-pilot-study
#5
Akira Sezai, Shunji Osaka, Hiroko Yaoita, Munehito Arimoto, Hiroaki Hata, Motomi Shiono
Direct oral anticoagulants have recently been recommended for non-valvular atrial fibrillation, but have rarely been studied in the field of cardiac surgery. We prospectively investigated the safety of edoxaban, a novel oral anticoagulant, for use in cardiac surgery patients with postoperative atrial fibrillation (POAF), which is the most common complication of cardiac surgery and can lead to stroke. The subjects were adult cardiac surgery patients with POAF who received oral edoxaban for 2 months in an open-label pilot study...
October 2016: Journal of Atrial Fibrillation
https://www.readbyqxmd.com/read/28493216/appropriateness-of-oral-anticoagulants-for-the-long-term-treatment-of-atrial-fibrillation-in-older-people-results-of-an-evidence-based-review-and-international-consensus-validation-process-oac-forta-2016
#6
REVIEW
Martin Wehling, Ronan Collins, Victor M Gil, Olivier Hanon, Roland Hardt, Martin Hoffmeister, Pedro Monteiro, Terence J Quinn, Dieter Ropers, Giuseppe Sergi, Freek W A Verheugt
BACKGROUND: Age appropriateness of anticoagulants for stroke prevention in atrial fibrillation is uncertain. OBJECTIVE: To review oral anticoagulants for the treatment of atrial fibrillation in older (age >65 years) people and to classify appropriate and inappropriate drugs based on efficacy, safety and tolerability using the Fit-fOR-The-Aged (FORTA) classification. METHODS: We performed a structured comprehensive review of controlled clinical trials and summaries of individual product characteristics to assess study and total patient numbers, quality of major outcome data and data of geriatric relevance...
May 10, 2017: Drugs & Aging
https://www.readbyqxmd.com/read/28467656/direct-oral-anticoagulants-vs-enoxaparin-for-prevention-of-venous-thromboembolism-following-orthopedic-surgery-a-dose-response-meta-analysis
#7
R A Boyd, L DiCarlo, J W Mandema
We carried out a dose-response model-based meta-analysis to assess venous thromboembolism (VTE) and bleeding with factor Xa (FXa) inhibitors (apixaban, edoxaban, rivaroxaban) and a thrombin inhibitor (dabigatran) compared with European (EU) (40 mg q.d.) and North American (NA) (30 mg Q12H) dose regimens of a low molecular weight heparin (enoxaparin) following orthopedic surgery. Statistically significant differences in both VTE and bleeding outcomes were found between the NA and EU doses of enoxaparin, with odds ratios (95% confidence interval) for the NA vs...
May 3, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28467190/risk-of-gastrointestinal-bleeding-during-anticoagulant-treatment
#8
Aitor Lanas-Gimeno, Angel Lanas
Gastrointestinal bleeding (GIB) is a major problem in patients on oral anticoagulation therapy. This issue has become even more pressing since the introduction of direct oral anticoagulants (DOACs) in 2009. Areas covered: Here we review current evidence related to GIB associated with oral anticoagulants, focusing on randomized controlled trials, meta-analyses, and post-marketing observational studies. Dabigatran 150 mg twice daily and rivaroxaban 20 mg once daily increase the risk of GIB compared to warfarin...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28466408/incidence-and-predictors-of-silent-cerebral-thromboembolic-lesions-after-catheter-ablation-for-atrial-fibrillation-in-patients-treated-with-direct-oral-anticoagulants
#9
Atsushi Doi, Masahiko Takagi, Jun Kakihara, Yusuke Hayashi, Hiroaki Tatsumi, Kohei Fujimoto, Kenichi Sugioka, Minoru Yoshiyama
There are few reports about the incidence and predictors of silent cerebral thromboembolic lesions (SCLs) after atrial fibrillation (AF) ablation in patients treated with direct oral anticoagulants (DOACs). The purpose of this study is to evaluate the incidence and predictors of SCLs after AF ablation with cerebral magnetic resonance imaging (C-MRI) in patients treated with DOACs. We enrolled 117 consecutive patients who underwent first AF ablation and received DOACs, including apixaban, dabigatran, edoxaban, and rivaroxaban...
May 2, 2017: Heart and Vessels
https://www.readbyqxmd.com/read/28458311/thrombosis-in-an-internal-jugular-vein-and-an-upper-limb-deep-vein-treated-with-edoxaban
#10
Mizuho Toratani, Akiko Hayashi, Naoki Nishiyama, Hidehiko Nakamura, Ryuji Chida, Takaaki Komatsu, Shiro Nakahara, Sayuki Kobayashi, Isao Taguchi
A 45-year-old man complained of swelling of the left side of his neck and left upper limb. Ultrasonography and enhanced computed tomography (CT) revealed thrombosis of the left internal jugular, subclavian, and brachiocephalic vein. Based on various examinations, the patient was diagnosed with idiopathic venous thrombosis early in his clinical course. There were no findings to suggest malignancy or abnormal coagulability. However, two months after the start of treatment, the patient was diagnosed with gastric cancer...
2017: Internal Medicine
https://www.readbyqxmd.com/read/28458008/risk-of-gastrointestinal-bleeding-in-patients-taking-non-vitamin-k-antagonist-oral-anticoagulants-a-systematic-review-and-meta-analysis
#11
Corey S Miller, Alastair Dorreen, Myriam Martel, Thao Huynh, Alan N Barkun
BACKGROUND AND AIMS: Non-vitamin K antagonist oral anticoagulants (NOACs) are convenient and effective in prevention and treatment of venous thromboembolism and prevention of stroke in patients with atrial fibrillation. However, these drugs have been associated with increased risk of gastrointestinal (GI) bleeding. We conducted a systematic review and meta-analysis to determine the risk of GI bleeding in patients receiving these drugs. METHODS: We searched the EMBASE, Medline, Cochrane, and ISI Web of knowledge databases through January 2016 for randomized trials that compared NOACs to conventional anticoagulants for approved indications...
April 27, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28435279/use-of-direct-oral-anticoagulants-for-the-prevention-and-treatment-of-thromboembolic-disease-in-patients-with-reduced-renal-function-a-short-review-of-the-clinical-evidence
#12
REVIEW
Kristine C Willett, Amanda M Morrill
BACKGROUND: The use of direct oral anticoagulants (DOACs) is restricted by the limitations of clinical trials guiding therapy for patients with renal impairment, as many of these trials excluded patients with severe renal impairment. There are currently four agents available: dabigatran, rivaroxaban, apixaban, and edoxaban. The purpose of this review was to 1) describe current recommended dosing for each DOAC and published postmarketing data, including case reports, on the use of these agents in the renally impaired; and 2) discuss patient adherence and satisfaction and the cost of these agents...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28423431/-treatment-and-secondary-prevention-of-venous-thromboembolism-change-in-oral-anticoagulation
#13
Thomas-Maria Helms, Dietrich Gulba, Ingo Ahrens, Andreas Schäfer, Johannes Hankowitz, Peter Kuhlencordt, Hans-Peter Lipp, Sigrid Nikol, Hanno Riess, Tom Stargardt, Peter Bramlage
With the recent approval of the fourth direct non vitamin K dependent oral anticoagulant (NOAC) edoxaban the range of available NOACs for the treatment of venous thromboembolism (VTE) has expanded. Shortly thereafter, two updated guidelines for the prevention and treatment of VTE have been published. In these NOACs are listed as equal anticoagulants to low-molecular weight heparin (LMWH), or fondaparinux (FDX), and VKA for the initial or maintenance treatment of VTE. All NOACs are approved for the maintenance therapy after VTE and two NOACs (rivaroxaban and apixaban) for the initial treatment in addition in an increased dose...
April 19, 2017: Deutsche Medizinische Wochenschrift
https://www.readbyqxmd.com/read/28413976/laboratory-monitoring-or-measurement-of-direct-oral-anticoagulants-doacs-advantages-limitations-and-future-challenges
#14
Emmanuel J Favaloro, Leonardo Pasalic, Jennifer Curnow, Giuseppe Lippi
BACKGROUND: The Direct Oral Anticoagulants (DOACs) represent a new generation of antithrombotic agents, providing direct inhibition of either thrombin (factor IIa; FIIa) or activated factor X (FXa). Around the globe, their use is progressively rising, as these new agents replace the historical anticoagulants (heparin and vitamin K antagonists including warfarin) for various clinical conditions in medical practice. Other acronyms used to designate DOACs include TSOAC (target specific oral anticoagulants) and NOAC (novel; or non-vitamin K antagonist oral anticoagulants)...
April 17, 2017: Current Drug Metabolism
https://www.readbyqxmd.com/read/28400546/management-of-bleeding-or-urgent-interventions-in-patients-treated-with-direct-oral-anticoagulants-doacs-2017-management-proposals-in-poland
#15
Piotr Pruszczyk, Anna Tomaszuk-Kazberuk, Agnieszka Słowik, Rafał Drwila, Grażyna Rydzewska, Krzysztof J Filipiak, Zbigniew Gaciong, Jarosław Kaźmierczak, Wojciech Marczyński, Jerzy Windyga, Adam Kobayashi, Janina Stepińska
Direct oral anticoagulants (DOACs) - apixaban, dabigatran, edoxaban and rivaroxaban - are mainly used in the prevention of thromboembolic complications in atrial fibrillation patients and in the treatment of venous thromboembolism. As compared to vitamin K antagonists (VKAs), they are characterized by at least similar efficacy and better safety profiles, especially with respect to intracranial hemorrhages. DOACs are more convenient therapeutic agents. The European Society of Cardiology 2016 guidelines clearly favor DOACs over VKAs in AF patients...
March 15, 2017: Polish Archives of Internal Medicine
https://www.readbyqxmd.com/read/28398377/-new-oral-anticoagulants-in-patients-with-atrial-fibrillation-efficacy-and-safety-data-from-the-real-world
#16
Letizia Riva, Giuseppe Di Pasquale
New oral anticoagulants (NOACs: dabigatran, rivaroxaban, apixaban and edoxaban) proved to be at least non-inferior to warfarin in reducing thromboembolic risk in patients with atrial fibrillation. In addition, NOACs have been demonstrated to be safe and associated with a significant reduction in major and intracranial bleeding events. With the exception of apixaban, an increase in gastrointestinal bleedings has been observed, but as a whole NOACs have been shown to reduce mortality with rates similar to those of warfarin...
March 2017: Giornale Italiano di Cardiologia
https://www.readbyqxmd.com/read/28396988/the-non-vitamin-k-antagonist-oral-anticoagulants-noacs-and-extremes-of-body-weight-a-systematic-literature-review
#17
REVIEW
Raffaele De Caterina, Gregory Y H Lip
The non-vitamin K antagonist oral anticoagulants (NOACs) exert their anticoagulant effect closely related to their plasma concentrations. Since their distribution volume is related to body weight (and its correlates, i.e., surface area and body mass index, BMI), extremes in body weight may affect their efficacy or safety. Four NOACs are currently available for long-term use, with few exceptions, in atrial fibrillation and venous thromboembolism: the direct thrombin inhibitor dabigatran etexilate, and the factor (F) Xa inhibitors rivaroxaban, apixaban, and edoxaban...
April 10, 2017: Clinical Research in Cardiology: Official Journal of the German Cardiac Society
https://www.readbyqxmd.com/read/28395781/pharmacological-secondary-prevention-in-patients-with-mesenterial-artery-atherosclerosis-and-arterial-embolism
#18
REVIEW
Anders Gottsäter
Visceral arteries such as the coeliac (CA), superior mesenteric (SMA), and the inferior mesenteric artery (IMA) might be affected by atherosclerotic occlusive lesions with or without thrombosis or embolization causing ischaemic symptoms from the gastrointestinal tract. After treatment of an acute event, these patients should be offered both non-pharmacological and pharmacological secondary prevention to reduce risk for future ischaemic arterial manifestations. Patients with mesenteric ischaemia caused by atherosclerosis should be evaluated concerning platelet antiaggregation with low dose aspirin or clopidogrel, and those with cardioembolic disease should be recommended anticoagulant treatment with either warfarin or one of the direct oral anticoagulants (DOAC; apixaban, dabigatran, edoxaban, or rivaroxaban)...
February 2017: Best Practice & Research. Clinical Gastroenterology
https://www.readbyqxmd.com/read/28392512/direct-oral-anticoagulants-for-the-treatment-of-venous-thromboembolism-in-japan
#19
Mashio Nakamura, Norikazu Yamada, Masaaki Ito
Direct oral anticoagulants (DOACs) were developed to compensate for the demerits of warfarin. In Japan, three factor Xa inhibitors are used for the treatment of venous thromboembolism (VTE): edoxaban, rivaroxaban, and apixaban. Despite problems, such as the inability to monitor their effect and the lack of an antidote, these inhibitors have the same efficacy as conventional treatment with warfarin, and they are associated with a significantly high degree of safety in relation to hemorrhagic complications. East Asians, including Japanese, suffer from hemorrhage more frequently; therefore, DOACs are considered to be highly effective...
April 7, 2017: Journal of Atherosclerosis and Thrombosis
https://www.readbyqxmd.com/read/28390791/edoxaban-how-does-the-newest-agent-fit-into-the-doac-landscape
#20
REVIEW
Caitlin M Gibson, Shannon W Finks
Edoxaban is the most recently approved factor Xa inhibitor within the class of direct oral anticoagulants (DOACs). Like other DOACs, edoxaban was approved by the US Food and Drug Administration for treatment of venous thromboembolism and prevention of stroke in patients with nonvalvular atrial fibrillation. Similar to other DOACs, edoxaban has fewer drug-drug interactions than warfarin and does not require routine laboratory monitoring. Unlike other DOACs, edoxaban has yet to be approved for secondary or postoperative venous thromboembolism thromboprophylaxis...
April 6, 2017: American Journal of Medicine
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