Evidence map›Paper›PMID 31276324›Full record

ArticleCPT: pharmacometrics & systems pharmacology2019

Enhancing the Quality of Rivaroxaban Exposure Estimates Using Prothrombin Time in the Absence of Pharmacokinetic Sampling.

Alexander Solms, Matthias Frede, Scott D Berkowitz, Anne Hermanowski-Vosatka, Dagmar Kubitza, Wolfgang Mueck, Theodore E Spiro, Stefan Willmann, Xiaoyu Yan, Liping Zhang and 1 more

Abstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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

4 citing papers in PubMed.

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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

11 authors.

Alexander SolmsClinical Pharmacometrics, Bayer AG, Berlin, Germany.
Matthias FredeStatistical Analytics Clinical Sciences, Bayer AG, Wuppertal, Germany.
Scott D BerkowitzClinical Development, Bayer U.S. LLC, Whippany, New Jersey, USA.
Anne Hermanowski-VosatkaJanssen Research & Development, LLC, Raritan, New Jersey, USA.
Dagmar KubitzaPharmacodynamics Cardiovascular, Bayer AG, Wuppertal, Germany.
Wolfgang MueckClinical Pharmacokinetics Cardiovascular, Bayer AG, Wuppertal, Germany.
Theodore E SpiroClinical Development, Bayer U.S. LLC, Whippany, New Jersey, USA.
Stefan WillmannStatistical Analytics Clinical Sciences, Bayer AG, Wuppertal, Germany.
Xiaoyu YanJanssen Research & Development, LLC, Raritan, New Jersey, USA.
Liping ZhangJanssen Research & 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

Prothrombin time (PT) is a measure of coagulation status and was assessed in the majority of patients in the rivaroxaban phase II and III clinical trials as a pharmacodynamic marker. In the absence of sufficient phase III pharmacokinetic (PK) data to provide individual exposure measures for input into rivaroxaban exposure-response analyses, the aim of the present study was to investigate the use of PT-adjustment approaches (i.e., the use of observed individual PT measurements) to enhance the prediction of individual rivaroxaban exposure metrics (derived using a previously developed integrated population PK model) based on the observed linear relationship between PT and rivaroxaban plasma concentrations. The PT-adjustment approaches were established using time-matched PK and PT measurements, which were available from 1,779 patients across four phase II trials and one phase III trial of rivaroxaban. PT-adjusted exposure estimates improved the identification of statistically significant effects when compared with covariate-only exposure estimates.

Indexed as

Blood CoagulationClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicHumansProthrombin TimeRivaroxabanRivaroxaban

Identifiers

PMID31276324
PMCPMC6875705

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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.