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Xarelto studies

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 14, 2016: Thrombosis and Haemostasis
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
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...
June 30, 2016: Clinical Cardiology
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
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
C F Munson, A J Reid
Novel oral anticoagulants (NOACs) have emerged as a good alternative to warfarin in the prevention of stroke for patients with atrial fibrillation. NOAC use is increasing rapidly; therefore, greater understanding of their use in the perioperative period is important for optimal care. Studies and reviews that reported on the use of NOACs were identified, with particular focus on the perioperative period. PubMed was searched for relevant articles published between January 2000 and August 2015. The inevitable rise in the use of NOACs such as rivaroxaban (Xarelto™), apixaban (Eliquis™), edoxaban (Lixiana™) and dabigatran (Pradaxa™) may present a simplified approach to perioperative anticoagulant management due to fewer drug interactions, rapidity of onset of action and relatively short half-lives...
May 2016: Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS
Michael R Lassen, Sylvia Haas, Reinhold Kreutz, Lorenzo G Mantovani, Gerlind Holberg, Alexander G G Turpie
BACKGROUND: The risk of venous thromboembolism is high in patients undergoing fracture-related major orthopedic surgery, but data on pharmacological thromboprophylaxis are limited. This analysis evaluated the effectiveness and safety of rivaroxaban after fracture-related orthopedic surgery in routine care compared with other pharmacological thromboprophylaxis (standard of care [SOC]). METHODS: The study population comprised a subset of patients with lower-limb fracture from XArelto in the prophylaxis of post-surgical venous thromboembolism after elective Major Orthopaedic Surgery of hip or knee (XAMOS; a phase IV noninterventional study) and a XAMOS extension study (XAMOS-Extra)...
March 2016: Clinical and Applied Thrombosis/hemostasis
Henry A Spiller, James B Mowry, Alfred Aleguas, Jill R K Griffith, Robert Goetz, Mark L Ryan, Stacey Bangh, Wendy Klein-Schwartz, Scott Schaeffer, Marcel J Casavant
STUDY OBJECTIVE: Rivaroxaban and apixaban are part of a new group of oral anticoagulants targeting factor Xa and approved by the Food and Drug Administration in 2011 and 2012. These oral anticoagulants are administered at fixed daily doses, without the need for laboratory-guided adjustments. There are limited data available on supratherapeutic doses or overdose of the oral Xa inhibitors. This study characterizes the clinical effect in patients exposed to rivaroxaban and apixaban. METHODS: A retrospective study collected data from 8 regional poison centers covering 9 states...
February 2016: Annals of Emergency Medicine
Antonio Gómez-Outes, Ma Luisa Suárez-Gea, Ramón Lecumberri, Ana Isabel Terleira-Fernández, Emilio Vargas-Castrillón
In recent years, several direct-acting oral anticoagulants (DOAC) have become available for use in Europe and other regions in indications related to prophylaxis and treatment of venous and arterial thromboembolism. They include the oral direct thrombin inhibitor dabigatran etexilate (Pradaxa, Boehringer Ingelheim) and the oral direct FXa inhibitors rivaroxaban (Xarelto, Bayer HealthCare), apixaban (Eliquis, Bristol-Myers Squibb), and edoxaban (Lixiana/Savaysa, Daiichi-Sankyo). The new compounds have a predictable dose response and few drug-drug interactions (unlike vitamin k antagonists), and they do not require parenteral administration (unlike heparins)...
November 2015: European Journal of Haematology
Louis Kwong, Alexander G G Turpie
Venous thromboembolism (VTE) is a potential cause of morbidity and mortality in patients after major orthopaedic surgery. Based on the results of the international phase III RECORD (Regulation of Coagulation in Orthopaedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) program, the oral, direct Factor Xa inhibitor rivaroxaban has been approved in many countries for the prevention of VTE after elective hip arthroplasty or knee arthroplasty. However, study results of randomized controlled trials may have limited generalizability to routine clinical practice in unselected patients...
May 2015: Current Orthopaedic Practice
Gregory Y H Lip, Christoph Hammerstingl, Francisco Marin, Riccardo Cappato, Isabelle Ling Meng, Bodo Kirsch, Eolo Morandi, Martin van Eickels, Ariel Cohen
There are still many unresolved issues concerning patient outcomes and prognostic factors in patients with atrial fibrillation (AF) and left atrial/left atrial appendage (LA/LAA) thrombi. Rivaroxaban (Xarelto®), a potent and highly selective oral, direct factor Xa inhibitor, is a new therapeutic option in this setting. The planned study program will consist of a prospective interventional study (X-TRA) and a retrospective observational registry (CLOT-AF). The primary objective of the X-TRA study is to explore the efficacy of rivaroxaban in the treatment of LA/LAA thrombi in patients with nonvalvular AF or atrial flutter, scheduled to undergo cardioversion or AF ablation, in whom an LA/LAA thrombus has been found on transesophageal echocardiography (TEE) before the procedure...
April 2015: American Heart Journal
Michael A Charters, Nicholas B Frisch, Nolan M Wessell, Christopher Dobson, Clifford M Les, Craig D Silverton
The oral Factor Xa inhibitor rivaroxaban (Xarelto) has been the pharmacologic agent used for venous thromboembolism (VTE) prophylaxis after primary hip and knee arthroplasty (THA/TKA) at our institution since February 2012. The purpose of our study was to compare rates of VTE and major bleeding between rivaroxaban and our previous protocol of enoxaparin after THA/TKA. A retrospective cohort study was performed including 2406 consecutive patients at our institution between 1/1/11 and 9/30/13. Patients who did not have unilateral primary THA/TKA or who received other anticoagulants were excluded...
July 2015: Journal of Arthroplasty
Walter Ageno, Lorenzo G Mantovani, Sylvia Haas, Reinhold Kreutz, Verena Haupt, Jonas Schneider, Alexander Gg Turpie
Venous thromboembolism (VTE), comprising deep vein thrombosis (DVT) and pulmonary embolism, poses a substantial clinical risk, and the incidence of these thrombotic-related diseases remains high. Anticoagulation aims to prevent thrombus extension and reduce the risk of recurrent events, particularly fatal pulmonary embolism. In EINSTEIN DVT, rivaroxaban was non-inferior to enoxaparin/vitamin K antagonists for the reduction of recurrent VTE, with a similar safety profile and a net clinical benefit. EINSTEIN EXT investigated patients receiving long-term treatment in whom there was no clear decision about continuing or stopping anticoagulation; rivaroxaban was superior to placebo in the reduction of recurrent VTE, showing an acceptable benefit-risk balance...
2014: Thrombosis Journal
A John Camm, Pierre Amarenco, Sylvia Haas, Susanne Hess, Paulus Kirchhof, Martin van Eickels, Alexander G G Turpie
Atrial fibrillation (AF) is associated with a fivefold increase in the risk of stroke. The Phase III ROCKET AF (Rivaroxaban Once-Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial showed that rivaroxaban, an oral, direct Factor Xa inhibitor, was noninferior to warfarin for the reduction of stroke or systemic embolism in patients with AF. Compared with warfarin, rivaroxaban significantly reduced rates of intracranial and fatal hemorrhages, although not rates of bleeding overall...
2014: Vascular Health and Risk Management
A Lai, N Davidson, S W Galloway, J Thachil
BACKGROUND: New oral anticoagulants (NOACs) offer an alternative to warfarin for preventing stroke in patients with atrial fibrillation. NOACs are expected to replace warfarin and other vitamin K antagonists for most of their indications in the future. Knowledge of the use of NOACs in the perioperative period is important for optimal care. METHODS: Studies that reported on the use of NOACs were identified, focusing on evidence-based guidance relating to the perioperative period...
June 2014: British Journal of Surgery
Nadia I Awad, Craig Cocchio
OBJECTIVE: Prothrombin complex concentrate (PCC) products are emerging as alternative strategies for reversing anticoagulant pharmacotherapy. Factor eight inhibitor bypassing activity (FEIBA, or anti-inhibitor coagulant complex) is an activated PCC (aPCC). Although FEIBA is approved by the FDA to control spontaneous bleeding episodes and to prevent bleeding with surgical interventions in hemophilia A and hemophilia B patients with inhibitors to factor VIII, recent data have suggested that the product may be used off-label as an anticoagulant-reversal agent...
November 2013: P & T: a Peer-reviewed Journal for Formulary Management
El Simpson, Md Stevenson, A Scope, E Poku, J Minton, P Evans
OBJECTIVE: To investigate the clinical effectiveness and cost-effectiveness of transthoracic echocardiography (TTE) in all patients who are newly diagnosed with atrial fibrillation (AF). DESIGN: Narrative synthesis reviews were conducted on the prognostic and diagnostic accuracy of TTE for, and prevalence of, pathologies in patients with AF. Databases were searched from inception. MEDLINE searches were conducted from March to August 2010, and reference lists of articles checked...
August 2013: Health Technology Assessment: HTA
Jonathan Douxfils, Anne Tamigniau, Bernard Chatelain, Christian Chatelain, Pierre Wallemacq, Jean-Michel Dogné, François Mullier
Possibilities to monitor rivaroxaban therapy could be useful in certain circumstances. Prothrombin time (PT) or chromogenic anti-Xa assays such as the Biophen Direct Factor Xa Inhibitor® (DiXaI) have been proposed to estimate rivaroxaban concentrations but are mainly based on in vitro studies. The study aim was to compare PT and Biophen DiXaI® measurements with liquid chromatography-tandem mass spectrometry (LC-MS/MS) measurements in plasma samples from patients treated with Xarelto®. Fifty-two plasma samples were included...
October 2013: Thrombosis and Haemostasis
Mareike Kristina Körber, Elisabeth Langer, Sabine Ziemer, Elisabeth Perzborn, Christine Gericke, Christian von Heymann
BACKGROUND: Rivaroxaban (Xarelto, Bayer HealthCare, Leverkusen, Germany) is a new oral anticoagulant drug. Anticoagulants may cause bleeding, thereby requiring reliable monitoring and efficient therapy. We investigated thromboelastometry versus routine coagulation tests to measure prophylactic and therapeutic concentrations of rivaroxaban and their reversal with prothrombin complex concentrate (PCC) and activated recombinant factor VII (rFVIIa) in vitro. METHODS: Rivaroxaban was solubilized, and PCC and rFVIIa were added in 2 concentrations to the rivaroxaban-spiked blood samples, and thromboelastometry and measurements were performed...
October 2014: Clinical and Applied Thrombosis/hemostasis
Natalie J Carter, Greg L Plosker
Rivaroxaban (Xarelto(®)), a direct factor Xa inhibitor, is approved for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in Canada or those with nonvalvular AF (NVAF) in the EU, US and Japan. It is administered at a fixed oral dose and generally does not require routine monitoring of coagulation parameters. In the ROCKET AF trial in patients with NVAF and a moderate to high risk of stroke, oral rivaroxaban 20 mg once daily (15 mg once daily in patients with moderate renal impairment) was noninferior to oral dose-adjusted warfarin once daily in preventing primary endpoint events (i...
May 2013: Drugs
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