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Rivaroxaban Precision Dosing Strategy for Real‐World Atrial Fibrillation Patients

Rivaroxaban is a direct‐acting oral anticoagulant approved to prevent strokes in patients with atrial fibrillation. Dosage recommendations are approved for all adult patients to receive either 15 mg or 20 mg once daily depending upon renal function. There are a number of reasons to believe rivaroxab...

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Autores principales: Konicki, Robyn, Weiner, Daniel, Herbert Patterson, J., Gonzalez, Daniel, Kashuba, Angela, Cao, Yanguang Carter, Gehi, Anil K., Watkins, Paul, Powell, J. Robert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7359950/
https://www.ncbi.nlm.nih.gov/pubmed/32267996
http://dx.doi.org/10.1111/cts.12766
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author Konicki, Robyn
Weiner, Daniel
Herbert Patterson, J.
Gonzalez, Daniel
Kashuba, Angela
Cao, Yanguang Carter
Gehi, Anil K.
Watkins, Paul
Powell, J. Robert
author_facet Konicki, Robyn
Weiner, Daniel
Herbert Patterson, J.
Gonzalez, Daniel
Kashuba, Angela
Cao, Yanguang Carter
Gehi, Anil K.
Watkins, Paul
Powell, J. Robert
author_sort Konicki, Robyn
collection PubMed
description Rivaroxaban is a direct‐acting oral anticoagulant approved to prevent strokes in patients with atrial fibrillation. Dosage recommendations are approved for all adult patients to receive either 15 mg or 20 mg once daily depending upon renal function. There are a number of reasons to believe rivaroxaban dosing could be more effective and/or safer for more patients if increased dosing precision is available. Because real‐world patients are more diverse than those studied in phase III clinical trials, we evaluated the extremes of creatinine clearance (CrCl) on rivaroxaban clearance using a published population pharmacokinetic model and applying exposure variation limits (±20%) based on published literature. The proposed dosing recommendations are 10 mg once daily (CrCl 15–29 ml/min), 15 mg once daily (CrCl 30–69 ml/min), 10 mg twice daily (CrCl 70–159 ml/min), and 15 mg twice daily (CrCl 160–250 ml/min). These new dosing recommendations should be prospectively tested for predictive accuracy and to assess the impact on AF patient efficacy and safety.
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spelling pubmed-73599502020-07-17 Rivaroxaban Precision Dosing Strategy for Real‐World Atrial Fibrillation Patients Konicki, Robyn Weiner, Daniel Herbert Patterson, J. Gonzalez, Daniel Kashuba, Angela Cao, Yanguang Carter Gehi, Anil K. Watkins, Paul Powell, J. Robert Clin Transl Sci Research Rivaroxaban is a direct‐acting oral anticoagulant approved to prevent strokes in patients with atrial fibrillation. Dosage recommendations are approved for all adult patients to receive either 15 mg or 20 mg once daily depending upon renal function. There are a number of reasons to believe rivaroxaban dosing could be more effective and/or safer for more patients if increased dosing precision is available. Because real‐world patients are more diverse than those studied in phase III clinical trials, we evaluated the extremes of creatinine clearance (CrCl) on rivaroxaban clearance using a published population pharmacokinetic model and applying exposure variation limits (±20%) based on published literature. The proposed dosing recommendations are 10 mg once daily (CrCl 15–29 ml/min), 15 mg once daily (CrCl 30–69 ml/min), 10 mg twice daily (CrCl 70–159 ml/min), and 15 mg twice daily (CrCl 160–250 ml/min). These new dosing recommendations should be prospectively tested for predictive accuracy and to assess the impact on AF patient efficacy and safety. John Wiley and Sons Inc. 2020-05-07 2020-07 /pmc/articles/PMC7359950/ /pubmed/32267996 http://dx.doi.org/10.1111/cts.12766 Text en © 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society of Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research
Konicki, Robyn
Weiner, Daniel
Herbert Patterson, J.
Gonzalez, Daniel
Kashuba, Angela
Cao, Yanguang Carter
Gehi, Anil K.
Watkins, Paul
Powell, J. Robert
Rivaroxaban Precision Dosing Strategy for Real‐World Atrial Fibrillation Patients
title Rivaroxaban Precision Dosing Strategy for Real‐World Atrial Fibrillation Patients
title_full Rivaroxaban Precision Dosing Strategy for Real‐World Atrial Fibrillation Patients
title_fullStr Rivaroxaban Precision Dosing Strategy for Real‐World Atrial Fibrillation Patients
title_full_unstemmed Rivaroxaban Precision Dosing Strategy for Real‐World Atrial Fibrillation Patients
title_short Rivaroxaban Precision Dosing Strategy for Real‐World Atrial Fibrillation Patients
title_sort rivaroxaban precision dosing strategy for real‐world atrial fibrillation patients
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7359950/
https://www.ncbi.nlm.nih.gov/pubmed/32267996
http://dx.doi.org/10.1111/cts.12766
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