Evidence map›Paper›PMID 29666400›Full record

ArticleScientific reports2018

The corticosteroid compounds prednisolone and vamorolone do not alter the nociception phenotype and exacerbate liver injury in sickle cell mice.

Luis E F Almeida, Jesse M Damsker, Sarah Albani, Nina Afsar, Sayuri Kamimura, Drew Pratt, David E Kleiner, Martha Quezado, Heather Gordish-Dressman, Zenaide M N Quezado

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Scientific reports, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.6field-weighted citation impact, top 31% 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.

NCT05166109 phase2completednot on this mapstarted 2022, after this paper: background citation

A Phase II Pilot Trial of Vamorolone vs. Placebo for the Treatment of Becker Muscular Dystrophy

TypeinterventionalSponsorReveraGen BioPharma, Inc.Ran2022 to 2025Enrolled46ConditionsBecker Muscular DystrophyArmsVamorolone, Placebo
NCT05185622 phase2completednot on this mapstarted 2022, after this paper: background citation

A Phase II Open-Label, Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)

TypeinterventionalSponsorSanthera PharmaceuticalsRan2022 to 2024Enrolled54ConditionsDuchenne Muscular DystrophyArmsVamorolone
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 13 citations in OpenAlex.

  1. 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

10 authors at 6 institutions in 1 country.

Luis E F AlmeidaDepartment of Perioperatice Medicine, National Institutes of Health Clinical Center, National Institutes of Health, Besthesda, MD, USA.
Jesse M DamskerReveragen BioPharma Inc., Rockville, MD, USA.
Sarah AlbaniSheikh Zayed Institute for Pediatric Surgical Innovation, Children's Research Institute, Children's National Health System, Washington, DC, USA.
Nina AfsarLaboratory of Pathology, National Cancer Institute, National Institutes of Health, Besthesda, MD, USA.
Sayuri KamimuraDepartment of Perioperatice Medicine, National Institutes of Health Clinical Center, National Institutes of Health, Besthesda, MD, USA.
Drew PrattLaboratory of Pathology, National Cancer Institute, National Institutes of Health, Besthesda, MD, USA.
David E KleinerLaboratory of Pathology, National Cancer Institute, National Institutes of Health, Besthesda, MD, USA.
Martha QuezadoLaboratory of Pathology, National Cancer Institute, National Institutes of Health, Besthesda, MD, USA.
Heather Gordish-DressmanCenter for Genetic Medicine Research, Children's Research Institute, Children's National Health System, Department of Integrative Systems Biology, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Zenaide M N QuezadoDepartment of Perioperatice Medicine, National Institutes of Health Clinical Center, National Institutes of Health, Besthesda, MD, USA. zquezado@nih.gov.
Children's National · USNational Cancer Institute · USNational Institutes of Health · USNational Institutes of Health Clinical Center · USGeorge Washington University · USReveraGen BioPharma (United States) · US

Funding

Postmortem PathologyZICBC010685 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI KLEINER, DAVID ERWIN · 2009 to 2025
$14.3M
Evaluation of VBP15 a dissociative steroidal analogue on pain and inflammationR41MD008829 · NIMHD · REVERAGEN BIOPHARMA, INC. · PI DAMSKER, JESSE, QUEZADO, ZENAIDE MARIA · 2014 to 2014
$225k
Neurobiology of pain and behavior changes associated with rare diseases and developmental disabilitiesZIACL090052 · CLC · CLINICAL CENTER · PI QUEZADO, ZENAIDE · 2017 to 2025
$0k
Pathobiology of pain in sickle cell diseaseZIACL090053 · CLC · CLINICAL CENTER · PI QUEZADO, ZENAIDE · 2017 to 2025
$0k
Development of novel strategies for the treatment of pain in childrenZIACL090054 · CLC · CLINICAL CENTER · PI QUEZADO, ZENAIDE · 2017 to 2025
$0k
CLC NIH HHS ZIA CL090053Intramural NIH HHS ZIA CL090053NIMHD NIH HHS R41 MD008829
6 · The paper itself

Abstract

Clinicians often hesitate prescribing corticosteroids to treat corticosteroid-responsive conditions in sickle cell disease (SCD) patients because their use can be associated with complications (increased hospital readmission, rebound pain, strokes, avascular necrosis, acute chest syndrome). Consequently, SCD patients may receive suboptimal treatment for corticosteroid-responsive conditions. We conducted a preclinical trial of dissociative (vamorolone) and conventional (prednisolone) corticosteroid compounds to evaluate their effects on nociception phenotype, inflammation, and organ dysfunction in SCD mice. Prednisolone and vamorolone had no significant effects on nociception phenotype or anemia in homozygous mice. Conversely, prednisolone and vamorolone significantly decreased white blood cell counts and hepatic inflammation. Interestingly, the effects of vamorolone were milder than those of prednisolone, as vamorolone yielded less attenuation of hepatic inflammation compared to prednisolone. Compared to controls and heterozygotes, homozygotes had significant liver necrosis, which was significantly exacerbated by prednisolone and vamorolone despite decreased hepatic inflammation. These hepatic histopathologic changes were associated with increases in transaminases and alkaline phosphatase. Together, these results suggest that, even in the setting of decreasing hepatic inflammation, prednisolone and vamorolone were associated with significant hepatic toxicity in SCD mice. These findings raise the possibility that hepatic function deterioration could occur with the use of corticosteroids (conventional and dissociative) in SCD.

Indexed as

Anemia, Sickle CellAnimalsAnti-Inflammatory AgentsChemical and Drug Induced Liver InjuryFemaleGlucocorticoidsInflammationLiverMaleMiceNociceptionPrednisolonePregnadienediolsAnti-Inflammatory AgentsGlucocorticoidsPrednisolonePregnadienediolsVBP15 compound

Identifiers

PMID29666400
PMCPMC5904156
OpenAlexW2804134535

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.