Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects
Charles Frost,Jessie Wang,Sunil Nepal,Alan Schuster,Yu Chen Barrett,Rogelio Mosqueda-Garcia,Richard A. Reeves,Frank LaCreta +7 more
TLDR
To evaluate apixaban single dose safety, tolerability, pharmacokinetics and pharmacodynamics and assess the effect of food on Apixaban pharmacokinetically, a large number of animals were tested.Abstract:
Aims
To evaluate apixaban single dose safety, tolerability, pharmacokinetics and pharmacodynamics and assess the effect of food on apixaban pharmacokinetics.read more
Citations
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Journal ArticleDOI
Interventional Spine and Pain Procedures in Patients on Antiplatelet and Anticoagulant Medications: Guidelines From the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain
Samer Narouze,Honorio T. Benzon,David A. Provenzano,Asokumar Buvanendran,Jose De Andres,Timothy R. Deer,Richard Rauck,Marc A. Huntoon +7 more
TL;DR: In this paper, the authors proposed a set of guidelines for interventional spine and pain procedures based on the American Society of Regional Anesthesia and Pain Medicine (ASRA) anticoagulation guidelines.
Journal ArticleDOI
Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects
Charles Frost,Sunil Nepal,Jessie Wang,Alan Schuster,Wonkyung Byon,Rebecca A. Boyd,Zhigang Yu,Andrew Shenker,Yu Chen Barrett,Rogelio Mosqueda-Garcia,Frank LaCreta +10 more
TL;DR: Multiple oral doses of apixaban were safe and well tolerated over a 10-fold dose range, with pharmacokinetics with low variability and concentration-related increases in clotting time measures.
Journal ArticleDOI
Effect of extremes of body weight on the pharmacokinetics, pharmacodynamics, safety and tolerability of apixaban in healthy subjects
Vijay V. Upreti,Jessie Wang,Yu Chen Barrett,Wonkyung Byon,Rebecca A. Boyd,Janice Pursley,Frank LaCreta,Charles Frost +7 more
TL;DR: The modest change inApixaban exposure is unlikely to require dose adjustment for apixaban based on body weight alone, however, caution is warranted in the presence of additional factors (such as severe renal impairment) that could increase apixaba exposure.
Journal ArticleDOI
Pharmacokinetics, pharmacodynamics, and safety of apixaban in subjects with end-stage renal disease on hemodialysis.
Xiaoli Wang,Giridhar S. Tirucherai,Thomas Marbury,Jessie Wang,Ming Chang,Donglu Zhang,Yan Song,Janice Pursley,Rebecca A. Boyd,Charles Frost +9 more
TL;DR: In conclusion, ESRD resulted in a modest increase in apixaban AUC and no increase in Cmax, and hemodialysis had a limited impact on Apixaban clearance.
Journal ArticleDOI
Impact of apixaban on routine and specific coagulation assays: a practical laboratory guide
TL;DR: PT and/or dilute PT cannot be used to assess apixaban pharmacodynamic properties and more specific and sensitive assays such as chromogenic FXa assays using specific calibrators are required.
References
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Journal ArticleDOI
Clinical laboratory measurement of direct factor Xa inhibitors: Anti-Xa assay is preferable to prothrombin time assay
TL;DR: The suitability of commercially available prothrombin time/international normalised ratio (PT/INR) and anti-FXa activity assays to measure FXa inhibitors in plasma was evaluated and suggested that anti-Xa activity was the better indicator of apixaban plasma concentrations.
Journal ArticleDOI
Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies.
Pancras C. Wong,Earl J. Crain,Baomin Xin,Ruth R. Wexler,Patrick Y.S. Lam,Donald J. P. Pinto,Joseph M. Luettgen,Robert M. Knabb +7 more
TL;DR: In vivo, apixaban was effective in the prevention of experimental thrombosis at doses that preserve hemostasis in rabbits and potent and selective, with a Ki of 0.08 nm for human FXa.
Journal ArticleDOI
Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement.
Joachim Stangier,Bengt I. Eriksson,Ola E. Dahl,Lennart Ahnfelt,Gerhard Nehmiz,Hildegard Stähle,Karin Rathgen,Robbyna Svard +7 more
TL;DR: Administration of the dabigatran etexilate capsule with food has no effect on the extent of dabig atran absorption, with a moderate decrease when coadministered with pantoprazole, and these pharmacokinetic characteristics confirm the suitability of this oral solid dosage form for use in future clinical trials.
Journal ArticleDOI
New Antithrombotic Drugs: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)
TL;DR: This chapter outlines the rationale for development of new antithrombotic agents, describes the new antiplatelet, anticoagulant, and fibrinolytic drugs, and provides clinical perspectives on the opportunities and challenges faced by these novel agents.
Journal ArticleDOI
Effects of the oral, direct factor Xa inhibitor rivaroxaban on commonly used coagulation assays.
Andreas Hillarp,F. Baghaei,I. Fagerberg Blixter,Kerstin M. Gustafsson,Lennart Stigendal,M. Sten-Linder,Karin Strandberg,Tomas L. Lindahl +7 more
TL;DR: The APTT‐based assay for APC resistance is affected in a dose‐dependent manner whereas an assay based on the activation of coagulation at the prothrombinase level was unaffected.
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