Evidence map›Paper›PMID 35133671›Full record

Trial reportHepatology (Baltimore, Md.)2022

Randomized placebo-controlled trial of losartan for pediatric NAFLD.

Miriam B Vos, Mark L Van Natta, Niviann M Blondet, Srinivasan Dasarathy, Mark Fishbein, Paula Hertel, Ajay K Jain, Saul J Karpen, Joel E Lavine, Saeed Mohammad and 10 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
5.0field-weighted citation impact, top 4% 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

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Article
  10. Mechanisms of assembly and remodelling of the extracellular matrix.Nature reviews. Molecular cell biology · 2024
    Review
  11. Article
  12. Review
  13. The combined pioglitazone and topiramate therapy for management of pediatric patients with severe MASLD.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Article
  14. The Renin-Angiotensin System in Liver Disease.International journal of molecular sciences · 2024
    Review
  15. Article
  16. Review
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  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 10 institutions in 1 country.

Miriam B VosDivision of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
Mark L Van NattaJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Niviann M BlondetDivision of Pediatric Gastroenterology and Hepatology, Seattle Children's Hospital, University of Washington, Seattle, Washington, USA.
Srinivasan DasarathyDivision of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Cleveland, Ohio, USA.
Mark FishbeinDepartment of Pediatrics, Feinberg Medical School of Northwestern University, Chicago, Illinois, USA.
Paula HertelDivision of Gastroenterology, Hepatology and Nutrition, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.
Ajay K JainDivision of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, St. Louis University, St. Louis, Missouri, USA.
Saul J KarpenDivision of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia, USA.ORCID 0000-0002-3379-7592
Joel E LavineDivision of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA.
Saeed MohammadDepartment of Pediatrics, Feinberg Medical School of Northwestern University, Chicago, Illinois, USA.ORCID 0000-0002-2950-2552
Laura A MirielJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Jean P MollestonDivision of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Indiana University School of Medicine/Riley Hospital for Children, Indianapolis, Indiana, USA.
Marialena MouzakiDivision of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
Arun SanyalDepartment of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.
Emily P SharkeyJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Jeffrey B SchwimmerDivision of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, California, USA.ORCID 0000-0001-8538-2877
James TonasciaJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Laura A WilsonJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Stavra A XanthakosDivision of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
NASH Clinical Research Network
Johns Hopkins University · USEmory University · USCincinnati Children's Hospital Medical Center · USNorthwestern University · USBaylor College of Medicine · USCleveland Clinic · USColumbia University · USRiley Hospital for Children · USSaint Louis University · USSeattle Children's Hospital · US

Funding

WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
QAQC Johns Hopkins Institute for Clinical and Translational ResearchUL1TR003098 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2019 to 2023
$57.7M
Northwestern University Clinical and Translational Science Institute (NUCATS)UL1TR001422 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI D'AQUILA, RICHARD · 2015 to 2023
$56.8M
Institute of Translational Health SciencesUL1TR000423 · NCATS · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2012 to 2016
$49.4M
Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
Pediatric Trials in Non-Alcoholic Steatohepatitis (NASH)U01DK061734 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ROHIT LOOMBA · 2002 to 2026
$24.4M
Stem Cell/Organoid and Genome Editing CoreP30DK078392 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI LEE ARMISTEAD DENSON · 2007 to 2026
$24.4M
Continuation of the Non-Alcoholic Steatohepatitis Clinical Research Network (NASHU01DK061730 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI TONASCIA, JAMES A · 2002 to 2018
$23.2M
San Diego Clinical and Translational Research InstituteUL1TR000100 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S · 2012 to 2015
$19.7M
NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1 TR000006NCATS NIH HHS UL1 TR000040NCATS NIH HHS UL1 TR000077NCATS NIH HHS UL1 TR000100NCATS NIH HHS UL1 TR000150NCATS NIH HHS UL1 TR000423NCATS NIH HHS UL1 TR000424NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1 TR001422NCATS NIH HHS UL1 TR002345NCATS NIH HHS UL1 TR003098NIDDK NIH HHS P30 DK078392NIDDK NIH HHS R01 DK125701NIDDK NIH HHS R03 DK096157NIDDK NIH HHS U01 DK061713NIDDK NIH HHS U01 DK061718NIDDK NIH HHS U01 DK061728NIDDK NIH HHS U01 DK061730NIDDK NIH HHS U01 DK061731NIDDK NIH HHS U01 DK061732NIDDK NIH HHS U01 DK061734NIDDK NIH HHS U01 DK061737NIDDK NIH HHS U01 DK061738NIDDK NIH HHS U24 DK061730NINR NIH HHS R01 NR019083
6 · The paper itself

Abstract

BACKGROUND AND

aimsTo date, no pharmacotherapy exists for pediatric NAFLD. Losartan, an angiotensin II receptor blocker, has been proposed as a treatment due to its antifibrotic effects. APPROACH AND

resultsThe Nonalcoholic Steatohepatitis Clinical Research Network conducted a multicenter, double-masked, placebo-controlled, randomized clinical trial in children with histologically confirmed NAFLD at 10 sites (September 2018 to April 2020). Inclusion criteria were age 8-17 years, histologic NAFLD activity score ≥ 3, and serum alanine aminotransferase (ALT) ≥ 50 U/l. Children received 100 mg of losartan or placebo orally once daily for 24 weeks. The primary outcome was change in ALT levels from baseline to 24 weeks, and the preset sample size was n = 110. Treatment effects were assessed using linear regression of change in treatment group adjusted for baseline value. Eighty-three participants (81% male, 80% Hispanic) were randomized to losartan (n = 43) or placebo (n = 40). During an enrollment pause, necessitated by the 2019 coronavirus pandemic, an unplanned interim analysis showed low probability (7%) of significant group difference. The Data and Safety Monitoring Board recommended early study termination. Baseline characteristics were similar between groups. The 24-week change in ALT did not differ significantly between losartan versus placebo groups (adjusted mean difference: 1.1 U/l; 95% CI = -30.6, 32.7; p = 0.95), although alkaline phosphatase decreased significantly in the losartan group (adjusted mean difference: -23.4 U/l; 95% CI = -41.5, -5.3; p = 0.01). Systolic blood pressure decreased in the losartan group but increased in placebo (adjusted mean difference: -7.5 mm Hg; 95% CI = -12.2, -2.8; p = 0.002). Compliance by pill counts and numbers and types of adverse events did not differ by group.

conclusionsLosartan did not significantly reduce ALT in children with NAFLD when compared with placebo.

Indexed as

HypertensionNon-alcoholic Fatty Liver DiseaseAdolescentAngiotensin Receptor AntagonistsBlood PressureChildDouble-Blind MethodFemaleHumansLosartanMaleTreatment OutcomeAngiotensin Receptor AntagonistsLosartan

Identifiers

PMID35133671
PMCPMC9288975
OpenAlexW4210925833

What OpenQuestion holds

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LicenceCC BY-NC
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.