Evidence map›Paper›PMID 26929777›Full record

ArticleTherapeutic advances in gastroenterology2016

Cardiovascular risk assessment in the treatment of nonalcoholic steatohepatitis: a secondary analysis of the MOZART trial.

Steven C Lin, Brandon Ang, Carolyn Hernandez, Ricki Bettencourt, Rashmi Jain, Joanie Salotti, Lisa Richards, Yuko Kono, Archana Bhatt, Hamed Aryafar and 5 more

2 registry-linked trialsOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic advances in gastroenterology, 2016. 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 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
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.

NCT01766713 phase2completednot on this map

Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis

TypeinterventionalSponsorUniversity of California, San DiegoRan2013 to 2014Enrolled50ConditionsNon Alcoholic SteatohepatitisArmsEzetimibe
NCT03198572 phase4unknown statusnot on this mapstarted 2017, after this paper: background citation

Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis: a Multicentre, Randomised, Placebo-controlled Trial

TypeinterventionalSponsorFudan UniversityRan2017 to 2024Enrolled120ConditionsNon-alcoholic SteatohepatitisArmsLifestyle intervention, Placebo, Berberine
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Non-alcoholic fatty liver disease and cardiovascular risk.World journal of gastrointestinal pathophysiology · 2017
    Review
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

15 authors at 1 institution in 1 country.

Steven C LinNAFLD Translational Research Unit, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA.
Brandon AngNAFLD Translational Research Unit, Division of Epidemiology, Department of Family and Preventive Medicine, University of California at San Diego, La Jolla, CA, USA.
Carolyn HernandezNAFLD Translational Research Unit, Division of Epidemiology, Department of Family and Preventive Medicine, University of California at San Diego, La Jolla, CA, USA.
Ricki BettencourtNAFLD Translational Research Unit, Division of Epidemiology, Department of Family and Preventive Medicine, University of California at San Diego, La Jolla, CA, USA.
Rashmi JainNAFLD Translational Research Unit, Division of Epidemiology, Department of Family and Preventive Medicine, University of California at San Diego, La Jolla, CA, USA.
Joanie SalottiNAFLD Translational Research Unit, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA.
Lisa RichardsNAFLD Translational Research Unit, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA.
Yuko KonoDivision of Gastroenterology, University of California at San Diego, La Jolla, CA, USA.
Archana BhattNAFLD Translational Research Unit, Division of Epidemiology, Department of Family and Preventive Medicine, University of California at San Diego, La Jolla, CA, USA.
Hamed AryafarDepartment of Radiology, University of California at San Diego, La Jolla, CA, USA.
Grace Y LinDepartment of Pathology, University of California at San Diego, La Jolla, CA, USA.
Mark A ValasekDepartment of Pathology, University of California at San Diego, La Jolla, CA, USA.
Claude B SirlinDepartment of Pathology and Liver Imaging Group, University of California at San Diego, La Jolla, CA, USA.
Sharon BrouhaDepartment of Radiology, University of California at San Diego, La Jolla, CA, USA.
Rohit LoombaProfessor of Medicine and Associate Director of Clinical Research, Division of Gastroenterology, Adjunct Professor, Division of Epidemiology, University of California at San Diego, Biomedical Research Facility II, 4A18, 9500 Gilman Drive, La Jolla, CA 92093, USA.
University of California, San Diego · US

Funding

GENETIC EPIDEMIOLOGY OF NONALCOHOLIC FATTY LIVER DISEASEK23DK090303 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LOOMBA, ROHIT · 2011 to 2014
$721k
NIDDK NIH HHS K23 DK090303
6 · The paper itself

Abstract

backgroundNonalcoholic steatohepatitis (NASH) is associated with increased cardiovascular risk and mortality. No US Food and Drug Administration (FDA) approved therapies for NASH are available; clinical trials to date have not yet systematically assessed for changes in cardiovascular risk. This study examines the prospective utility of cardiovascular risk assessments, the Framingham risk score (FRS) and coronary artery calcium (CAC) score, as endpoints in a NASH randomized clinical trial, and assesses whether histologic improvements lead to lower cardiovascular risk.

methodsSecondary analysis of a 24-week randomized, double-blind, placebo-controlled trial (MOZART) in which 50 biopsy-proven NASH patients received oral ezetimibe 10 mg daily (n = 25) versus placebo (n = 25). Biochemical profiling, FRS, CAC scores, liver biopsies were obtained at baseline and endpoint.

resultsEzetimibe improved FRS whereas placebo did not (4.4 ± 6.2 to 2.9 ± 4.8, p = 0.038; 3.0 ± 4.4 to 2.9 ± 4.2, p = 0.794). CAC scores did not change with ezetimibe or placebo (180.4 ± 577.2 to 194.1 ± 623.9, p = 0.293; 151.4 ± 448.9 to 183.3 ± 555.7, p = 0.256). Ezetimibe improved FRS and CAC scores in more patients than placebo (48% versus 23%, p = 0.079, and 21% versus 0%, p = 0.090, respectively), though not significantly. No differences were noted in cardiovascular risk scores among histologic responders versus nonresponders.

conclusionsEzetimibe improved FRS whereas placebo did not. FRS and CAC scores improved in a greater proportion of patients with ezetimibe; this trend did not reach significance. These findings indicate the utility and feasibility of monitoring cardiovascular risk in a NASH trial. The utility of CAC scores may be higher in trials of longer duration (⩾52 weeks) and with older patients (age ⩾45). ClinicalTrials.gov registration: NCT01766713.

Indexed as

coronary artery calciumfatty liverFramingham riskhepatic steatosisscore

Identifiers

PMID26929777
PMCPMC4749859
OpenAlexW2290981234

What OpenQuestion holds

Textmetadata
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.