Evidence map›Paper›PMID 29660785›Full record

ArticleCPT: pharmacometrics & systems pharmacology2018

Integrated Population Pharmacokinetic Analysis of Rivaroxaban Across Multiple Patient Populations.

Stefan Willmann, Liping Zhang, Matthias Frede, Dagmar Kubitza, Wolfgang Mueck, Stephan Schmidt, Alexander Solms, Xiaoyu Yan, Dirk Garmann

Abstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Stefan WillmannClinical Pharmacometrics, Bayer AG, Wuppertal, Germany.
Liping ZhangGlobal Clinical Pharmacology, Janssen Research and Development LLC, Raritan, New Jersey, USA.
Matthias FredeClinical Pharmacometrics, Bayer AG, Wuppertal, Germany.
Dagmar KubitzaPharmacodynamics Cardiovascular, Bayer AG, Wuppertal, Germany.
Wolfgang MueckClinical Pharmacokinetics Cardiovascular, Bayer AG, Wuppertal, Germany.
Stephan SchmidtDepartment of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, Florida, USA.
Alexander SolmsClinical Pharmacometrics, Bayer AG, Berlin, Germany.
Xiaoyu YanGlobal Clinical Pharmacology, Janssen Research and Development LLC, Raritan, New Jersey, USA.
Dirk GarmannClinical Pharmacometrics, Bayer AG, Wuppertal, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AdultBody WeightClinical Trials, Phase II as TopicFemaleHumansKidneyKidney Function TestsMaleMetabolic Clearance RateMiddle AgedModels, BiologicalRivaroxabanRivaroxaban

Identifiers

PMID29660785
PMCPMC5980303

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.