Fixed dose rivaroxaban can be used in extremes of bodyweight: A population pharmacokinetic analysis.
anticoagulants
body weight
drug monitoring
pharmacokinetics
rivaroxaban
Journal
Journal of thrombosis and haemostasis : JTH
ISSN: 1538-7836
Titre abrégé: J Thromb Haemost
Pays: England
ID NLM: 101170508
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
21
02
2020
revised:
28
04
2020
accepted:
26
05
2020
pubmed:
9
6
2020
medline:
20
5
2021
entrez:
9
6
2020
Statut:
ppublish
Résumé
Emerging safety and efficacy data for rivaroxaban suggest traditional therapy and rivaroxaban are comparable in the morbidly obese. However, real-world data that indicate pharmacokinetic (PK) parameters are comparable at the extremes of body size are lacking. The International Society of Thrombosis and Haemostasis Scientific and Standardisation Committee (ISTH SSC) suggests avoiding the use of direct oral anticoagulants (DOACs) in patients weighing >120 kg or with a body mass index >40 kg/m To generate a population PK model to understand the influence of bodyweight on rivaroxaban exposure from clinical practice data. Rivaroxaban plasma concentrations and patient characteristics were collated between 2013 and 2018 at King's College Hospital anticoagulation clinic. A population PK model was developed using a nonlinear mixed effects approach and then used to simulate rivaroxaban concentrations at the extremes of bodyweight. A robust population PK model derived from 913 patients weighing between 39 kg and 172 kg was developed. The model included data from n = 86 >120 kg, n = 74 BMI >40 kg/m Our work demonstrates rivaroxaban can be used at extremes of bodyweight provided renal function is satisfactory. We recommend that the ISTH SSC revises the current guidance with respect to rivaroxaban at extremes of body size.
Sections du résumé
BACKGROUND
Emerging safety and efficacy data for rivaroxaban suggest traditional therapy and rivaroxaban are comparable in the morbidly obese. However, real-world data that indicate pharmacokinetic (PK) parameters are comparable at the extremes of body size are lacking. The International Society of Thrombosis and Haemostasis Scientific and Standardisation Committee (ISTH SSC) suggests avoiding the use of direct oral anticoagulants (DOACs) in patients weighing >120 kg or with a body mass index >40 kg/m
OBJECTIVES
To generate a population PK model to understand the influence of bodyweight on rivaroxaban exposure from clinical practice data.
METHOD
Rivaroxaban plasma concentrations and patient characteristics were collated between 2013 and 2018 at King's College Hospital anticoagulation clinic. A population PK model was developed using a nonlinear mixed effects approach and then used to simulate rivaroxaban concentrations at the extremes of bodyweight.
RESULTS
A robust population PK model derived from 913 patients weighing between 39 kg and 172 kg was developed. The model included data from n = 86 >120 kg, n = 74 BMI >40 kg/m
CONCLUSIONS
Our work demonstrates rivaroxaban can be used at extremes of bodyweight provided renal function is satisfactory. We recommend that the ISTH SSC revises the current guidance with respect to rivaroxaban at extremes of body size.
Identifiants
pubmed: 32511863
doi: 10.1111/jth.14948
pii: S1538-7836(22)01652-X
doi:
Substances chimiques
Anticoagulants
0
Rivaroxaban
9NDF7JZ4M3
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2296-2307Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2020 International Society on Thrombosis and Haemostasis.
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