Evidence map›Paper›PMID 31139866›Full record

ArticleEuropean journal of clinical pharmacology2019

Intra- and inter- individual rivaroxaban concentrations and potential bleeding risk in patients with atrial fibrillation.

Marko Miklič, Alenka Mavri, Nina Vene, Lisbeth Söderblom, Mojca Božič-Mijovski, Anton Pohanka, Jovan Antovic, Rickard E Malmström

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In one paragraph

Article in European journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 7% of its field
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

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 45 citations in OpenAlex.

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  14. Rivaroxaban Plasma Concentration and Clinical Outcomes on Older Patients with Non-valvular Atrial Fibrillation and Pulmonary Infection.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024
    Observational
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  19. Physiologically-based pharmacokinetic modeling to predict drug-drug interactions of dabigatran etexilate and rivaroxaban in the Chinese older adults.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2023
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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

8 authors at 3 institutions in 2 countries.

Marko MikličDepartment of Vascular Diseases, University Medical Centre Ljubljana, Zaloška 2, SI-1000, Ljubljana, Slovenia.
Alenka MavriDepartment of Vascular Diseases, University Medical Centre Ljubljana, Zaloška 2, SI-1000, Ljubljana, Slovenia. alenka.mavri@kclj.si.
Nina VeneDepartment of Vascular Diseases, University Medical Centre Ljubljana, Zaloška 2, SI-1000, Ljubljana, Slovenia.
Lisbeth SöderblomDepartment of Coagulation Research, Institute for Molecular Medicine and Surgery, Karolinska Institutet, & Department of Clinical Chemistry, Karolinska University Hospital, Stockholm, Sweden.
Mojca Božič-MijovskiDepartment of Vascular Diseases, University Medical Centre Ljubljana, Zaloška 2, SI-1000, Ljubljana, Slovenia.
Anton PohankaDepartment of Laboratory Medicine Huddinge, Division of Clinical Pharmacology, Karolinska Institutet & Clinical Pharmacology, Karolinska University Hospital, Stockholm, Sweden.
Jovan AntovicDepartment of Coagulation Research, Institute for Molecular Medicine and Surgery, Karolinska Institutet, & Department of Clinical Chemistry, Karolinska University Hospital, Stockholm, Sweden.
Rickard E MalmströmDepartment of Medicine Solna, Karolinska Institutet & Clinical Pharmacology, Karolinska University Hospital, Stockholm, Sweden.
Ljubljana University Medical Centre · SIKarolinska University Hospital · SEKarolinska Institutet · SE

Funding

Javna Agencija za Raziskovalno Dejavnost RS P3-0308
6 · The paper itself

Abstract

backgroundRoutine laboratory monitoring of rivaroxaban and dose adjustment relating to exposure is currently not recommended. However, in certain clinical situations, assessment of rivaroxaban levels is desirable.

objectivesTo examine inter- and intra-subject plasma rivaroxaban variability in patients with atrial fibrillation (AF) and to correlate these results to clinical outcomes. PATIENTS/

methodsWe included 60 patients with AF treated with rivaroxaban: half on 20 mg daily (R20) and half on 15 mg daily (R15). Three trough and peak blood samples were collected with an interval of 6-8 weeks apart. Plasma rivaroxaban concentration was measured directly by liquid chromatography-tandem mass-spectrometry (LC-MS/MS) and indirectly by anti-Xa for rivaroxaban, prothrombin time (PT), and activated partial thromboplastin time (APTT).

resultsPatients on R15 were older (76 ± 6 vs 71 ± 6 years), had lower creatinine clearance (60 ± 26 vs 99 ± 32 mL/min), higher CHADS

conclusionsThere is a pronounced inter-, but not intra-individual variability in the rivaroxaban trough levels in patients with AF. Assessment of trough rivaroxaban concentration with LC-MS/MS or anti-Xa, but not with APTT or PT, may help to identify patients at increased risk of bleeding.

Indexed as

Biological Variation, IndividualBiological Variation, PopulationAgedAged, 80 and overAtrial FibrillationBlood Coagulation TestsDose-Response Relationship, DrugDrug MonitoringFactor Xa InhibitorsFemaleHemorrhageHumansMaleRisk AssessmentRivaroxabanFactor Xa InhibitorsRivaroxabanAnti-Xa assayAtrial fibrillationDrug monitoringLC-MS/MSRivaroxaban

Identifiers

PMID31139866
OpenAlexW2947478175

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.