Evidence map›Paper›PMID 23762827›Full record

ArticleBioMed research international2013

Prediction of clinically relevant safety signals of nephrotoxicity through plasma metabolite profiling.

W B Mattes, H G Kamp, E Fabian, M Herold, G Krennrich, R Looser, W Mellert, A Prokoudine, V Strauss, B van Ravenzwaay and 9 more

Abstract read
In one paragraph

Article in BioMed research international, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Article
  2. Analytical and Omics-Based Advances in the Study of Drug-Induced Liver Injury.Toxicological sciences : an official journal of the Society of Toxicology · 2021
    Review
  3. Review
  4. Review
  5. Article
  6. Article
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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

19 authors.

W B MattesPharmPoint Consulting, Poolesville, MD 20837, USA.
H G Kamp
E Fabian
M Herold
G Krennrich
R Looser
W Mellert
A Prokoudine
V Strauss
B van Ravenzwaay
T Walk
H Naraoka
K Omura
I Schuppe-Koistinen
S Nadanaciva
E D Bush
N Moeller
P Ruiz-Noppinger
S P Piccoli

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Addressing safety concerns such as drug-induced kidney injury (DIKI) early in the drug pharmaceutical development process ensures both patient safety and efficient clinical development. We describe a unique adjunct to standard safety assessment wherein the metabolite profile of treated animals is compared with the MetaMap Tox metabolomics database in order to predict the potential for a wide variety of adverse events, including DIKI. To examine this approach, a study of five compounds (phenytoin, cyclosporin A, doxorubicin, captopril, and lisinopril) was initiated by the Technology Evaluation Consortium under the auspices of the Drug Safety Executive Council (DSEC). The metabolite profiles for rats treated with these compounds matched established reference patterns in the MetaMap Tox metabolomics database indicative of each compound's well-described clinical toxicities. For example, the DIKI associated with cyclosporine A and doxorubicin was correctly predicted by metabolite profiling, while no evidence for DIKI was found for phenytoin, consistent with its clinical picture. In some cases the clinical toxicity (hepatotoxicity), not generally seen in animal studies, was detected with MetaMap Tox. Thus metabolite profiling coupled with the MetaMap Tox metabolomics database offers a unique and powerful approach for augmenting safety assessment and avoiding clinical adverse events such as DIKI.

Indexed as

MetabolomeAnimalsCaptoprilCyclosporineDoxorubicinDrug-Related Side Effects and Adverse ReactionsFemaleHumansKidney DiseasesLisinoprilMaleMetabolomicsPhenytoinRatsRats, WistarCaptoprilCyclosporineDoxorubicinLisinoprilPhenytoin

Identifiers

PMID23762827
PMCPMC3673329

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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.