Evidence map›Paper›PMID 25429853›Full record

Trial reportAlimentary pharmacology & therapeutics2015

NASH resolution is associated with improvements in HDL and triglyceride levels but not improvement in LDL or non-HDL-C levels.

K E Corey, R Vuppalanchi, L A Wilson, O W Cummings, N Chalasani, NASH CRN

Registry-linked trialOpen access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00063622 (Clinical Research Network in Nonalcoholic Steatohepatitis), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
3.0field-weighted citation impact, top 9% 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.

NCT00063622 phase3completednot on this map

Clinical Research Network in Nonalcoholic Steatohepatitis: Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)

TypeinterventionalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2005 to 2009Enrolled247ConditionsLiver DiseasesArmsPioglitazone, Vitamin E, Matching placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Differential Effects of Cardiometabolic Risk Factors on All-Cause Mortality in United States Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
    Article
  6. Review
  7. Article
  8. Life (Basel, Switzerland) · 2023
    Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. Dallas Steatosis Index Identifies Patients With Nonalcoholic Fatty Liver Disease.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2020
    Article
  19. Review
  20. Article
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

6 authors at 4 institutions in 1 country.

K E CoreyMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
R Vuppalanchi
L A Wilson
O W Cummings
N Chalasani
NASH CRN
Indiana University School of MedicineHarvard University · USIndiana University – Purdue University Indianapolis · USJohns Hopkins University · US

Funding

Transform Dissemination and Implementation Science in CTSA ProgramsUL1TR002319 · NCATS · UNIVERSITY OF WASHINGTON · PI John K. Amory · 2017 to 2026
$100.0M
Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
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
UCSF Liver Core CenterP30DK026743 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Holger Willenbring · 1986 to 2026
$30.7M
Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval ProcessUL1TR002529 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI MOE, SHARON M, WIEHE, SARAH ELIZABETH · 2018 to 2022
$27.2M
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
Indiana Clinical and Translational Sciences InstituteUL1TR001108 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI DENNE, SCOTT C., SHEKHAR, ANANTHA · 2013 to 2017
$23.3M
Continuation of the Non-Alcoholic Steatohepatitis Clinical Research Network (NASHU01DK061730 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI TONASCIA, JAMES A · 2002 to 2018
$23.2M
NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1TR000004NCATS NIH HHS UL1 TR000006NCATS NIH HHS UL1TR000006NCATS NIH HHS UL1 TR000040NCATS NIH HHS UL1TR000040NCATS NIH HHS UL1 TR000058NCATS NIH HHS UL1TR000058NCATS NIH HHS UL1 TR000067NCATS NIH HHS UL1TR000067NCATS NIH HHS UL1 TR000077NCATS NIH HHS UL1TR000077NCATS NIH HHS UL1 TR000100NCATS NIH HHS UL1TR000100NCATS NIH HHS UL1 TR000150NCATS NIH HHS UL1TR000150NCATS NIH HHS UL1 TR000423NCATS NIH HHS UL1TR000423NCATS NIH HHS UL1 TR000424NCATS NIH HHS UL1TR000424NCATS NIH HHS UL1 TR000436NCATS NIH HHS UL1TR000436NCATS NIH HHS UL1 TR000439NCATS NIH HHS UL1TR000439NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1TR000448NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1TR000454NCATS NIH HHS UL1 TR001108NCATS NIH HHS UL1 TR002319NIDDK NIH HHS K23 DK099422NIDDK NIH HHS K23DK099422-0NIDDK NIH HHS P30 DK026743NIDDK NIH HHS U01 DK061713NIDDK NIH HHS U01DK061713NIDDK NIH HHS U01 DK061718NIDDK NIH HHS U01DK061718NIDDK NIH HHS U01 DK061728NIDDK NIH HHS U01DK061728NIDDK NIH HHS U01 DK061730NIDDK NIH HHS U01DK061730NIDDK NIH HHS U01 DK061731NIDDK NIH HHS U01DK061731NIDDK NIH HHS U01 DK061732NIDDK NIH HHS U01DK061732NIDDK NIH HHS U01 DK061734NIDDK NIH HHS U01DK061734NIDDK NIH HHS U01 DK061737NIDDK NIH HHS U01DK061737NIDDK NIH HHS U01 DK061738NIDDK NIH HHS U01DK061738
6 · The paper itself

Abstract

backgroundNonalcoholic steatohepatitis (NASH) is associated with dyslipidemia and cardiovascular disease (CVD).

aimTo determine the relationship between resolution of NASH and dyslipidemia.

methodsIndividuals in the Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis (PIVENS) trial with paired liver biopsies and fasting lipid levels were included (N = 222). In the PIVENS trial individuals were randomised to pioglitazone 30 mg, vitamin E 800 IU or placebo for 96 weeks. Change in lipid levels at 96 weeks was compared between those with and without NASH resolution.

resultsDyslipidemia at baseline was frequent, with low high-density lipoprotein (HDL) (<40 mg/dL in men or <50 mg/dL in women) in 63%, hypertriglyceridaemia (≥150 mg/dL) in 46%, hypercholesterolaemia (≥200 mg/dL) in 47% and triglycerides (TG)/HDL >5.0 in 25%. Low-density lipoprotein (LD) ≥160 mg/dL was found in 16% and elevated non-HDL cholesterol (non-HDL-C) (≥130 mg/dL) in 73%. HDL increased with NASH resolution but decreased in those without resolution (2.9 mg/dL vs. -2.5 mg/dL, P < 0.001). NASH resolution was associated with significant decreases in TG and TG/HDL ratio compared to those without resolution (TG: -21.1 vs. -2.3 mg/dL, P = 0.03 and TG/HDL: -0.7 vs. 0.1, P = 0.003). Non-HDL-C, LDL and cholesterol decreased over 96 weeks in both groups, but there was no significant difference between groups. Treatment group did not impact lipids.

conclusionsNASH resolution is associated with improvements in TG and HDL but not in other cardiovascular disease risk factors including LDL and non-HDL-C levels. Individuals with resolution of NASH may still be at increased risk of cardiovascular disease. ClinicalTrials.gov identifier: NCT00063622.

Indexed as

AdultAgedCardiovascular DiseasesCholesterolCholesterol, LDLFemaleHumansLipoproteins, HDLMaleMiddle AgedNon-alcoholic Fatty Liver DiseasePioglitazoneRiskThiazolidinedionesTriglyceridesVitamin ECholesterolCholesterol, LDLHDL-triglycerideLipoproteins, HDLPioglitazoneThiazolidinedionesTriglyceridesVitamin E

Identifiers

PMID25429853
PMCPMC4424085
OpenAlexW2077461853

What OpenQuestion holds

Textmetadata
LicenceTDM
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.