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https://www.readbyqxmd.com/read/29657592/design-and-baseline-characteristics-of-the-xarelto-post-authorization-safety-effectiveness-study-in-japanese-patients-with-atrial-fibrillation-xapass
#1
Satoshi Ogawa, Kazuo Minematsu, Takanori Ikeda, Takanari Kitazono, Jyoji Nakagawara, Susumu Miyamoto, Yuji Murakawa, Yohei Ohashi, Makiko Takeichi, Yutaka Okayama, Satoshi Yamanaka, Lyo Inuyama
Background: The phase III Japanese Rivaroxaban Once-Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (J-ROCKET AF) showed that the rivaroxaban group had a lower event rate of intracranial bleeding than the warfarin group and that rivaroxaban was noninferior to warfarin for the principal safety outcome. However, safety and effectiveness data from unselected patients with AF in everyday clinical practice in Japan are lacking...
April 2018: Journal of Arrhythmia
https://www.readbyqxmd.com/read/29566414/understanding-the-value-of-real-world-evidence-focus-on-stroke-prevention-in-atrial-fibrillation-with-rivaroxaban
#2
A John Camm, Craig I Coleman, Torben Bjerregaard Larsen, Peter Brønnum Nielsen, Capt Sally Tamayo
Real-world data are a well-recognized component within the drug lifecycle, and such data are generated from a range of sources and study designs, including claims databases, electronic health records, non-interventional studies (NIS) and registries. While this information can be of vital clinical importance, there may be challenges in understanding the relevance of the differing study designs, endpoints and populations. Here, we summarize the value of real-world evidence and considerations pertinent to their use in clinical research...
March 22, 2018: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/29447643/a-case-of-leukocytoclastic-vasculitis-caused-by-novel-anticoagulant-rivaroxaban
#3
Riley Dean, Alison M Messer, Melanie Pickett, Richard Jahan-Tigh
Cutaneous leukocytoclastic vasculitis (LCV) is type of small vessel vasculitis that commonly presents as palpable purpura involving the lower extremities and buttocks. Approximately half of cases are idiopathic, but the disease may be triggered by infection, drug reaction, inflammatory disease, or other causes. We report a case of leukocytoclastic vasculitis secondary to the novel anticoagulant rivaroxaban (Xarelto®).
November 15, 2017: Dermatology Online Journal
https://www.readbyqxmd.com/read/29432317/outcomes-of-early-surgical-intervention-in-geriatric-proximal-femur-fractures-among-patients-receiving-direct-oral-anticoagulation
#4
Nathan A Franklin, Ashley H Ali, Richard K Hurley, Hassan R Mir, Michael J Beltran
OBJECTIVE: To evaluate the prehospital use of direct oral anticoagulant (DOAC) agents on the outcomes of early surgical fixation of a geriatric hip fracture. DESIGN: Case control study. SETTING: Two academic Level 1 trauma centers. INTERVENTION: Early (<48 h) surgical fixation of a geriatric proximal femur fracture. PATIENTS: Nineteen patients receiving Pradaxa (dabigatran), Eliquis (apixaban), or Xarelto (rivaroxaban) who underwent surgery between 2010 and 2015 and 74 control patients...
June 2018: Journal of Orthopaedic Trauma
https://www.readbyqxmd.com/read/29345985/cyp3a-activity-and-rivaroxaban-serum-concentrations-in-russian-patients-with-deep-vein-thrombosis
#5
Dmitriy Alexeyevich Sychev, Arshak Vardanyan, Aleksandr Rozhkov, Edita Hachatryan, Ani Badanyan, Valery Smirnov, Anna Ananichuk, Natalya Denisenko
BACKGROUND: Rivaroxaban is metabolized in the liver via CYP3A4, the cytochrome involved in the metabolism of nearly 50% of all medications. Thus, its effective concentration depends on multiple pharmacologic parameters. METHODS: The primary goal of our research was to study the correlation between the CYP3A family activity and the safety and efficacy of anticoagulant therapy with rivaroxaban in patients with deep vein thrombosis (DVT). Thirty one patients with DVT aged 21-83 years, 18 men and 13 women, received rivaroxaban (Xarelto) 30 mg/day for 21 days after diagnosis and 20 mg/day for the follow-up period of 6 months...
January 2018: Genetic Testing and Molecular Biomarkers
https://www.readbyqxmd.com/read/29304263/the-prevalence-of-adverse-ocular-hemorrhagic-events-in-patients-utilizing-oral-anticoagulant-and-antiplatelet-therapy-in-routine-clinical-practice
#6
Dattanand M Sudarshana, Eleni K Konstantinou, Sruthi Arepalli, Fabiana Q Silva, Andrew P Schachat, Justis P Ehlers, Rishi P Singh
BACKGROUND AND OBJECTIVE: Previous literature assessing ocular hemorrhagic complications of anticoagulant/antiplatelet medications in routine clinical practice is limited. This study evaluates the prevalence of spontaneous ocular hemorrhagic events associated with anticoagulation/antiplatelet therapy. PATIENTS AND METHODS: A retrospective study was performed to identify patients taking anticoagulants (rivaroxaban [Xarelto; Janssen Pharmaceuticals, Beerse, Belgium], bivalirudin [Angiomax; The Medicines Company, Parsippany, NJ], lepirudin [Refludan; Bayer HealthCare Pharmaceuticals, Berlin, Germany], dabigatran [Pradaxa; Boehringer Ingelheim, Ingelheim am Rhein, Germany], and argatroban) and antiplatelet agents (clopidogrel [Plavix; Bristol-Myers Squibb, New York City, NY], prasugrel [Effient; Lilly Medical, Indianapolis, IN], and ticagrelor [Brilinta; AstraZeneca, Cambridge, UK]) who presented for an eye examination...
January 1, 2018: Ophthalmic Surgery, Lasers & Imaging Retina
https://www.readbyqxmd.com/read/29181265/off-label-use-of-direct-oral-anticoagulants-for-left-ventricular-thrombus-is-it-appropriate
#7
George Degheim, Abeer Berry, Marcel Zughaib
A 57 year old gentleman with a history of non-ischemic cardiomyopathy and paroxysmal atrial fibrillation presented with worsening lower extremity edema and dyspnea on exertion. He had been compliant with his medications including rivaroxaban (Xarelto) for atrial fibrillation that he takes with the evening meal daily. His echocardiogram showed an ejection fraction of 10-15% and a new left ventricle (LV) apical thrombus. During his hospital stay, he developed right sided weakness. Magnetic Resonance Imaging showed a subacute infarct involving the left parietal lobe...
2017: American Journal of Cardiovascular Disease
https://www.readbyqxmd.com/read/28892526/rivaroxaban-vs-warfarin-sodium-in-the-ultra-early-period-after-atrial-fibrillation-related-mild-ischemic-stroke-a-randomized-clinical-trial
#8
RANDOMIZED CONTROLLED TRIAL
Keun-Sik Hong, Sun U Kwon, Sang Hun Lee, Ji Sung Lee, Yong-Jae Kim, Tae-Jin Song, Young Dae Kim, Man-Seok Park, Eung-Gyu Kim, Jae-Kwan Cha, Sang Min Sung, Byung-Woo Yoon, Oh Young Bang, Woo-Keun Seo, Yang-Ha Hwang, Seong Hwan Ahn, Dong-Wha Kang, Hyun Goo Kang, Kyung-Ho Yu
Importance: In atrial fibrillation (AF)-related acute ischemic stroke, the optimal oral anticoagulation strategy remains unclear. Objective: To test whether rivaroxaban or warfarin sodium is safer and more effective for preventing early recurrent stroke in patients with AF-related acute ischemic stroke. Design, Setting, and Participants: A randomized, multicenter, open-label, blinded end point evaluation, comparative phase 2 trial was conducted from April 28, 2014, to December 7, 2015, at 14 academic medical centers in South Korea among patients with mild AF-related stroke within the previous 5 days who were deemed suitable for early anticoagulation...
October 1, 2017: JAMA Neurology
https://www.readbyqxmd.com/read/28674871/real-life-use-of-rivaroxaban-in-the-netherlands-data-from-the-xarelto-for-prevention-of-stroke-in-patients-with-atrial-fibrillation-xantus-registry
#9
R Pisters, S P G van Vugt, M A Brouwer, A Elvan, W L Ten Holt, P A G Zwart, P Kirchhof, H J G M Crijns, M E W Hemels
BACKGROUND: The Xarelto for Prevention of Stroke in Patients with Atrial Fibrillation (XANTUS) registry investigated the safety and efficacy of the factor Xa inhibitor rivaroxaban. We studied the Dutch XANTUS cohort to a ssess drug safety and prescription patterns in the Netherlands. METHODS: The XANTUS registry was designed as a European prospective, observational study among patients with non-valvular atrial fibrillation. Major bleeding and all-cause mortality were assessed every three months during a 1-year follow-up period...
October 2017: Netherlands Heart Journal
https://www.readbyqxmd.com/read/28625215/assessing-coagulation-by-rotational-thromboelastometry-rotem-in-rivaroxaban-anticoagulated-blood-using-hemostatic-agents
#10
Jonathan Bar, Alexa David, Tarek Khader, Mary Mulcare, Christopher Tedeschi
Introduction The use of direct oral anticoagulants (DOACs) such as rivaroxaban (Xarelto) is increasingly common. However, therapies for reversing anticoagulation in the event of hemorrhage are limited. This study investigates the ability of hemostatic agents to improve the coagulation of rivaroxaban-anticoagulated blood, as measured by rotational thromboelastometry (ROTEM). Hypothesis/Problem If a chitosan-based hemostatic agent (Celox), which works independently of the clotting cascade, is applied to rivaroxaban-anticoagulated blood, it should improve coagulation by decreasing clotting time (CT), decreasing clot formation time (CFT), and increasing maximum clot firmness (MCF)...
October 2017: Prehospital and Disaster Medicine
https://www.readbyqxmd.com/read/28395685/the-benefit-of-pharmacological-venous-thromboprophylaxis-in-foot-and-ankle-surgery
#11
N P Saragas, P N F Ferrao, B F Jacobson, E Saragas, A Strydom
BACKGROUND: Ten percent of patients with a deep-vein thrombosis (DVT) will develop a fatal pulmonary embolism (PE), often initially asymptomatic. The risks and benefits of pharmacological thromboprophylaxis are well documented in respect of total joint arthroplasty and hip fractures, but little is understood about the incidence of venous thromboembolism (VTE) or the potential risks and benefits of chemoprophylaxis in foot and ankle surgery. OBJECTIVE: To determine whether prophylactic chemoprophylaxis had any impact on the prevention of VTE in a cohort of foot and ankle surgical patients requiring the combination of below-knee cast immobilisation and non-weightbearing for ≥4 weeks...
March 29, 2017: South African Medical Journal, Suid-Afrikaanse Tydskrif Vir Geneeskunde
https://www.readbyqxmd.com/read/28008269/perioperative-management-of-direct-oral-anticoagulants-doacs-a-systemic-review
#12
REVIEW
Tagore Sunkara, Emmanuel Ofori, Vadim Zarubin, Megan E Caughey, Vinaya Gaduputi, Madhavi Reddy
Direct oral anticoagulants (DOACs) are in wide use among patients requiring both short- and long-term anticoagulation, mainly due to their ease of use and the lack of monitoring requirements. With growing use of DOACs, it is imperative that physicians be able to manage patients on these medications, especially in the perioperative period. We aim to provide guidance on the management of DOACs in the perioperative period. In this review, we performed an extensive literature search summarizing the management of patients on direct-acting anticoagulants in the perioperative period...
2016: Health Services Insights
https://www.readbyqxmd.com/read/27725023/correlation-between-rivaroxaban-xarelto-plasma-activity-patient-clinical-variables-and-outcomes-in-a-south-african-centre
#13
S Louw, N P Saragas, P N Ferrao, T F Chirwa, B F Jacobson
BACKGROUND: Low-molecular-weight heparin and vitamin K antagonists such as warfarin are the gold standard for prohylaxis and treatment of venous thromboembolic disease (VTED). Direct oral anticoagulants (DOACs) result in predictable anticoagulation with significantly reduced inter- and intra-patient variability. DOAC absorption is rapid, with a short half-life and relatively few drug interactions. DOACs are effective and safe at fixed doses without activity monitoring. However, specific situations may require assessment of accurate drug activity...
September 8, 2016: South African Medical Journal, Suid-Afrikaanse Tydskrif Vir Geneeskunde
https://www.readbyqxmd.com/read/27623681/rivaroxaban-real-world-evidence-validating-safety-and-effectiveness-in-clinical-practice
#14
Jan Beyer-Westendorf, A John Camm, Craig I Coleman, Sally Tamayo
Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain...
September 28, 2016: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/27580286/caution-when-prescribing-xarelto-to-first-time-patients
#15
Ann Shastay
No abstract text is available yet for this article.
September 2016: Home Healthcare Now
https://www.readbyqxmd.com/read/27455072/does-anticoagulant-medication-alter-fracture-healing-a-morphological-and-biomechanical-evaluation-of-the-possible-effects-of-rivaroxaban-and-enoxaparin-using-a-rat-closed-fracture-model
#16
Peter Michael Prodinger, Rainer Burgkart, Kilian Kreutzer, Franz Liska, Hakan Pilge, Andreas Schmitt, Martina Knödler, Boris Michael Holzapfel, Alexander Hapfelmeier, Thomas Tischer, Oliver Bissinger
Low molecular weight heparin (LMWH) is routinely used to prevent thromboembolism in orthopaedic surgery, especially in the treatment of fractures or after joint-replacement. Impairment of fracture-healing due to increased bone-desorption, delayed remodelling and lower calcification caused by direct osteoclast stimulation is a well-known side effect of unfractioned heparin. However, the effect of LMWH is unclear and controversial. Recent studies strongly suggest impairment of bone-healing in-vitro and in animal models, characterized by a significant decrease in volume and quality of new-formed callus...
2016: PloS One
https://www.readbyqxmd.com/read/27437154/successful-treatment-and-secondary-prevention-of-venous-thrombosis-secondary-to-beh%C3%A3-et-disease-with-rivaroxaban
#17
Ana Boban, Catherine Lambert, Cedric Hermans
We here present the successful initial treatment and secondary prophylaxis of superficial venous thrombosis secondary to Behçet's disease by a novel anticoagulant drug, rivaroxaban (Xarelto®). To our knowledge, this is the first case of using an oral direct inhibitor of FXa in this setting. Our findings are promising; the outcome was favourable without any adverse effect noted. We propose that the patients with Behçet's disease and venous thrombosis might benefit from the advantages of the new anticoagulant drug...
2016: Case Reports in Hematology
https://www.readbyqxmd.com/read/27362695/impact-of-switching-from-a-vitamin-k-antagonist-to-rivaroxaban-on-satisfaction-with-anticoagulation-therapy-the-xantus-acts-substudy
#18
MULTICENTER STUDY
Craig I Coleman, Sylvia Haas, Alexander G G Turpie, Silvia Kuhls, Susanne Hess, Thomas Evers, Pierre Amarenco, Paulus Kirchhof, A John Camm
BACKGROUND: The efficacy, safety, and ease of use of rivaroxaban may reduce anticoagulation-treatment burden and improve nonvalvular atrial fibrillation (NVAF) patient satisfaction compared with vitamin K antagonists (VKAs). HYPOTHESIS: Transitioning from a VKA to rivaroxaban improves treatment satisfaction in routine practice. METHODS: Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation (XANTUS) is a prospective, noninterventional study in patients with NVAF prescribed rivaroxaban for prevention of stroke in routine practice...
October 2016: Clinical Cardiology
https://www.readbyqxmd.com/read/27313435/a-pilot-study-comparing-hospital-readmission-rates-in-patients-receiving-rivaroxaban-or-enoxaparin-after-orthopedic-surgery
#19
Melissa A Herschman, Frank S Rigelsky, Sandra S Axtell
PURPOSE: A pilot study was conducted to determine whether rivaroxaban (Xarelto, Janssen Pharmaceuticals) resulted in a lower 30-day all-cause readmission rate compared with enoxaparin (Lovenox, Sanofi-Aventis) after total hip arthroplasty (THA) or total knee arthroplasty (TKA) at a community hospital. METHODS: The study was a single-center, retrospective, chart-review investigation involving patients who underwent THA or TKA between May 2013 and May 2014. The study's primary endpoint was the 30-day all-cause readmission rate...
June 2016: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/27112188/clinical-and-economic-impact-of-rivaroxaban-on-the-burden-of-atrial-fibrillation-the-case-study-of-japan
#20
Masatsugu Hori, Shunya Ikeda, Ken Okumura, Shinya Matsuda, Yukihiro Koretsune, Calypso Montouchet, Emi Watanabe-Fujinuma, Thomas Evers, Bruno Rossi, Lewis Ruff, Jean-Baptiste Briere
OBJECTIVES: Atrial fibrillation (AF) affects an estimated 1.5 million individuals in Japan, increasing their stroke risk and imposing considerable costs on the Japanese healthcare system. To reduce stroke incidence, guidelines recommend using anticoagulants in moderate-to-high risk non-valvular AF (NVAF) patients; however, many patients receive no treatment, aspirin only, or remain poorly-controlled on vitamin K antagonists (VKAs) due to high VKA discontinuation rates and non-adherence to guidelines...
September 2016: Journal of Medical Economics
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