Unknown

Dataset Information

0

Integrated Population Pharmacokinetic Analysis of Rivaroxaban Across Multiple Patient Populations.


ABSTRACT: The population pharmacokinetics (PK) of rivaroxaban have been evaluated in several population-specific models. We developed an integrated population PK model using pooled data from 4,918 patients in 7 clinical trials across all approved indications. Effects of gender, age, and weight on apparent clearance (CL/F) and apparent volume of distribution (V/F), renal function, and comedication on CL/F, and relative bioavailability as a function of dose (F) were analyzed. Virtual subpopulations for exposure simulations were defined by age, creatinine clearance (CrCL) and body mass index (BMI). Rivaroxaban PK were adequately described by a one-compartment disposition model with a first-order absorption rate constant. Significant effects of CrCL, use of comedications, and study population on CL/F, age, weight, and gender on V/F, and dose on F were identified. CrCL had a modest influence on exposure, whereas age and BMI had a minor influence. The model was suitable to predict rivaroxaban exposure in patient subgroups of special interest.

SUBMITTER: Willmann S 

PROVIDER: S-EPMC5980303 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

altmetric image

Publications

Integrated Population Pharmacokinetic Analysis of Rivaroxaban Across Multiple Patient Populations.

Willmann Stefan S   Zhang Liping L   Frede Matthias M   Kubitza Dagmar D   Mueck Wolfgang W   Schmidt Stephan S   Solms Alexander A   Yan Xiaoyu X   Garmann Dirk D  

CPT: pharmacometrics & systems pharmacology 20180416 5


The population pharmacokinetics (PK) of rivaroxaban have been evaluated in several population-specific models. We developed an integrated population PK model using pooled data from 4,918 patients in 7 clinical trials across all approved indications. Effects of gender, age, and weight on apparent clearance (CL/F) and apparent volume of distribution (V/F), renal function, and comedication on CL/F, and relative bioavailability as a function of dose (F) were analyzed. Virtual subpopulations for expo  ...[more]

Similar Datasets

| S-EPMC8520753 | biostudies-literature
| S-EPMC8089078 | biostudies-literature
| S-EPMC9291861 | biostudies-literature
| S-EPMC4026632 | biostudies-other
| S-EPMC4449373 | biostudies-literature
| S-EPMC6278136 | biostudies-literature
| S-EPMC5192970 | biostudies-literature
| S-EPMC8537465 | biostudies-literature
| S-EPMC9297990 | biostudies-literature
| S-EPMC3726366 | biostudies-literature