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use of rivaroxaban in children

Julieta Weirthein, Dennis Scolnik, Nili Yanai Milshtein, Tali Capua, Miguel Glatstein
Novel oral anticoagulants offer equivalent or improved therapeutic profiles compared with warfarin, with less risk of bleeding, no interactions with food, and no need for routine laboratory monitoring. Caution must be exercised in using these drugs in certain patient populations, for example, renal insufficiency, those receiving additional antithrombotic therapy, those with questionable compliance, children, and those with a high risk of gastrointestinal bleeding. One of the novel oral anticoagulants, rivaroxaban, is a direct Factor Xa inhibitor, used to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, deep vein thrombosis, and pulmonary embolism...
January 15, 2018: Pediatric Emergency Care
Vlad Calin Radulescu
Venous thromboembolism (VTE) is very uncommon in children and adolescents compared with older adults, though its incidence has significantly increased over the past two decades. Given the rarity of the condition, the data on pediatric VTE lag behind the adult experience and consequently the management of VTE in children is, in large part, modeled on the adult strategies. This approach has certain limitations, given that young children have developmental particularities of the hemostatic system and differences in the pharmacokinetics and pharmacodynamics of various anticoagulant agents...
November 2017: Seminars in Thrombosis and 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
Thomas Vanassche, Christophe Vandenbriele, Kathelijne Peerlinck, Peter Verhamme
INTRODUCTION: Venous thromboembolism (VTE) causes substantial morbidity and mortality worldwide. The traditional treatment of VTE, with an initial therapy with (low molecular weight) heparin or fondaparinux and a continued treatment with vitamin K antagonists, is effective but has limitations. AREAS COVERED: The current review summarizes the results of the Phase III trials with the new oral direct factor Xa inhibitors rivaroxaban, apixaban and edoxaban and provides a meta-analysis of these trials in the subgroups of elderly patients (> 75 years) and patients with impaired renal function...
April 2015: Expert Opinion on Pharmacotherapy
Luis Almenar, José Luis Zunzunegui, Gonzalo Barón, José Ignacio Carrasco, Juan José Gómez-Doblas, Josep Comín, Vivencio Barrios, M Teresa Subirana, Beatriz Díaz-Molina
In the year 2012, 3 scientific sections-heart failure and transplant, congenital heart disease, and clinical cardiology-are presented together in the same article. The most relevant development in the area of heart failure and transplantation is the 2012 publication of the European guidelines for heart failure. These describe new possibilities for some drugs (eplerenone and ivabradine); expand the criteria for resynchronization, ventricular assist, and peritoneal dialysis; and cover possibilities of percutaneous repair of the mitral valve (MitraClip(®))...
April 2013: Revista Española de Cardiología
Chantal Attard, Paul Monagle, Dagmar Kubitza, Vera Ignjatovic
The use of anticoagulants in neonates is increasing because of the medical advances improving the long-term survival of very sick infants who are at risk of venous thromboembolism (VTE). Current anticoagulation therapy in neonates is less than ideal, because of the physiological differences compared to children and adults regarding the pathophysiology of thrombosis and pharmacology of the drug. Limitations associated with conventional anticoagulants have prompted the development of novel drugs that specifically target the key proteins in the coagulation system...
April 2014: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
J Beyer-Westendorf, S Gehrisch
BACKGROUND: The direct factor Xa inhibitor rivaroxaban is approved for venous thromboembolism (VTE) treatment in adults. However, in all phase-III trials children or adolescents have not been included. For under-aged VTE patients, current standard treatment consists of low molecular weight heparin or Vitamin K antagonists. Rivaroxaban could be an attractive alternative, however, no data on the pharmacokinetics (PK) of rivaroxaban in adolescents are currently available. PATIENT, METHODS: We report PK data for rivaroxaban derived from a girl (age:15 years), who presented three month after acute deep vein thrombosis, already receiving rivaroxaban therapy...
2014: Hämostaseologie
Donald L Yee, Sarah H O'Brien, Guy Young
Given the rising incidence of thrombotic complications in paediatric patients, understanding of the pharmacologic behaviour of anticoagulant drugs in children has gained importance. Significant developmental differences between children and adults in the haemostatic system and pharmacologic parameters for individual drugs highlight potentially unique aspects of anticoagulant pharmacology in this special and vulnerable population. This review focuses on pharmacologic information relevant to the dosing of unfractionated heparin, low molecular weight heparin, warfarin, bivalirudin, argatroban and fondaparinux in paediatric patients...
November 2013: Clinical Pharmacokinetics
J M Kittelson, A C Spyropoulos, J L Halperin, C M Kessler, S Schulman, G Steg, A G G Turpie, N R Cutler, W R Hiatt, N A Goldenberg
Antithrombotic trials in venous thromboembolism treatment and prevention, including those evaluating the new oral anticoagulants, have typically evaluated thromboembolism risk as an efficacy endpoint and bleeding risk as a separate safety endpoint. Findings often occur in opposition (i.e. decreased thromboembolism accompanied by increased bleeding, or vice-versa), leading to variable interpretation of the results, which may ultimately be judged as equivocal. In this paper, we offer an alternative to traditional designs based on the concept of a bivariate primary endpoint that accounts for simultaneous effects on antithrombotic efficacy and harm due to bleeding...
August 2013: Journal of Thrombosis and Haemostasis: JTH
C Attard, P Monagle, D Kubitza, V Ignjatovic
INTRODUCTION: Current anticoagulation therapy in children is less than ideal, requiring regular venous monitoring and dosing adjustments. Limitations associated with conventional anticoagulants have prompted the development of novel drugs that specifically target key proteins in the coagulation system. Rivaroxaban is the first oral, direct Factor Xa inhibitor available for the prevention of venous thromboembolism in adults. Its predictable pharmacokinetic profile, high oral bioavailability and once-daily dosing make rivaroxaban an optimal anticoagulant that warrants investigation in children...
November 2012: Thrombosis Research
Werner Streif, Walter Ageno
Venous thrombosis and pulmonary embolism rarely occur in children but are associated with significant morbidity and mortality. Venous thromboembolism (VTE) mostly affects children with severe underlying conditions and multiple risk factors. Newborns and adolescents are at the highest risk. Standard and low molecular weight heparins and vitamin K antagonists are routinely used for the prevention and treatment of VTE. The new anticoagulants, both parenteral such as argatroban, bivalirudin and fondaparinux and oral such as dabigatran and rivaroxaban, have favourable pharmacological properties, all are approved for clinical use in adults and are currently being investigated in children...
February 2011: Wiener Medizinische Wochenschrift
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