Evidence map›Paper›PMID 30414331›Full record

Observational studyBritish journal of clinical pharmacology2019

The impact of tacrolimus exposure on extrarenal adverse effects in adult renal transplant recipients.

Olivia Campagne, Donald E Mager, Daniel Brazeau, Rocco C Venuto, Kathleen M Tornatore

Open access · bronzeAbstract readObservational Study
In one paragraph

Observational study in British 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 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
1.7field-weighted citation impact, top 15% 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

22 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
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  10. Observational
  11. Immunogenicity of Recombinant Adeno-Associated Virus (AAV) Vectors for Gene Transfer.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Review
  12. Review
  13. Article
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  19. Beyond Deterministic Models in Drug Discovery and Development.Trends in pharmacological sciences · 2020
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Olivia CampagneDepartment of Pharmaceutical Sciences, University at Buffalo, SUNY, Buffalo, NY, USA.
Donald E MagerDepartment of Pharmaceutical Sciences, University at Buffalo, SUNY, Buffalo, NY, USA.
Daniel BrazeauDepartment of Pharmaceutical Sciences, College of Pharmacy, University of New England, Portland, ME, USA.
Rocco C VenutoErie County Medical Center, Division of Nephrology; Department of Medicine: Nephrology Division; School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.
Kathleen M TornatoreErie County Medical Center, Division of Nephrology; Department of Medicine: Nephrology Division; School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.ORCID 0000-0003-2028-4998
Erie County Medical Center · USNew England College · USUniversité Paris Cité · FRUniversity at Buffalo, State University of New York · US

Funding

Age and Race Influences on Immunosuppression after Renal TransplantR01AG056392 · NIA · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI TORNATORE, KATHLEEN M · 2018 to 2022
$3.5M
Genomic and Cellular Markers and Chronic Renal Allograft FunctionR21DK077325 · NIDDK · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI TORNATORE, KATHLEEN M · 2009 to 2010
$427k
NIA NIH HHS R01 AG056392NIDDK NIH HHS R21 DK077325
6 · The paper itself

Abstract

aimsTacrolimus has been associated with notable extrarenal adverse effects (AEs), which are unpredictable and impact patient morbidity. The association between model-predicted tacrolimus exposure metrics and standardized extrarenal AEs in stable renal transplant recipients was investigated and a limited sampling strategy (LSS) was developed to predict steady-state tacrolimus area under the curve over a 12-h dosing period (AUC

methodsAll recipients receiving tacrolimus and mycophenolic acid ≥6 months completed a 12-h cross-sectional observational pharmacokinetic-pharmacodynamic study. Patients were evaluated for the presence of individual and composite gastrointestinal, neurological, and aesthetic AEs during the study visit. The associations between AEs and tacrolimus exposure metrics generated from a published population pharmacokinetic model were investigated using a logistic regression analysis in NONMEM 7.3. An LSS was determined using a Bayesian estimation method with the same patients.

resultsDose-normalized tacrolimus AUC

conclusionsSeveral AEs (i.e. diarrhoea, dyspepsia, insomnia and neurological AE ratio) were associated with tacrolimus dose normalized AUC

Indexed as

Models, BiologicalAdministration, OralAdultAgedArea Under CurveCross-Sectional StudiesDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsDrug Therapy, CombinationFemaleGraft RejectionHumansImmunosuppressive AgentsIncidenceKidney TransplantationMaleImmunosuppressive AgentsMycophenolic AcidTacrolimusadverse effectsarea under the curveAUClimited samplingtacrolimus; pharmacokinetics

Identifiers

PMID30414331
PMCPMC6379234
OpenAlexW2900121860

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.