Evidence mapPaperPMID 28575232Full record

Trial reportThe Journal of clinical endocrinology and metabolism2017

Liver Safety of Statins in Prediabetes or T2DM and Nonalcoholic Steatohepatitis: Post Hoc Analysis of a Randomized Trial.

Fernando Bril, Paola Portillo Sanchez, Romina Lomonaco, Beverly Orsak, Joan Hecht, Fermin Tio, Kenneth Cusi

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 5 pooled it
5.7field-weighted citation impact, top 3% 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

45 citing papers in PubMed, 5 syntheses or guidelines pooled it, 96 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Guideline
  5. Pooled it
  6. Effects of Pitavastatin on Insulin Sensitivity and Liver Fat: A Randomized Clinical Trial.The Journal of clinical endocrinology and metabolism · 2018
    Trial
  7. Review
  8. Liver disease in people living with HIV infection: a changing landscape.Nature reviews. Gastroenterology & hepatology · 2026
    Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Pharmacological Approaches to Nonalcoholic Fatty Liver Disease: Current and Future Therapies.Diabetes spectrum : a publication of the American Diabetes Association · 2024
    Article
  19. Article
  20. Pleotropic effects of statins: the dilemma of wider utilization of statin.The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2023
    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

7 authors at 4 institutions in 1 country.

Fernando BrilDivision of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, Florida 32610.
Paola Portillo SanchezDivision of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, Florida 32610.
Romina LomonacoDivision of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, Florida 32610.
Beverly OrsakDivision of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229.
Joan HechtAudie L. Murphy Veterans Affairs Medical Center, San Antonio, Texas 78229.
Fermin TioDepartment of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229.
Kenneth CusiDivision of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, Florida 32610.
University of Florida · USThe University of Texas Health Science Center at San Antonio · USMalcom Randall VA Medical Center · USMurphy Oil Corporation (United States) · US

Funding

UAB Diabetes Research CenterP30DK079626 · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2025 to 2025
$1.3M
CSRD VA I01 CX000167NIDDK NIH HHS P30 DK079626
6 · The paper itself

Abstract

Context: Patients with nonalcoholic fatty liver disease have a high cardiovascular risk, but statins are rarely prescribed because of fear of hepatotoxicity. Objective: To prospectively assess the long-term safety of statins in patients with prediabetes/type 2 diabetes mellitus (T2DM) and nonalcoholic steatohepatitis (NASH). Design: Post hoc analysis of statin use during a randomized, controlled trial assessing pioglitazone vs placebo for NASH. Patients: A total of 101 patients (86 receiving statins) with biopsy-proven NASH and prediabetes/T2DM were followed for up to 36 months. Interventions: Oral glucose tolerance test and percutaneous liver biopsy (baseline, month 18, and month 36); liver magnetic resonance spectroscopy and euglycemic insulin clamp (baseline and month 18). Main Outcome Measures: Histologic and biochemical safety of statin use among patients with NASH. Results: Only 37% of patients were receiving statins at enrollment despite their high cardiovascular risk. Statin nonusers had higher plasma alanine aminotransferase levels but similar histologic severity of liver disease at baseline. In both statin users and nonusers, the same number of patients (n = 4) had a twofold or greater increase in plasma aminotransferases during follow-up. One statin nonuser was discontinued from the study because of this elevation. Values returned to normal without any active measure in all other cases. No changes on liver histology or hepatic insulin resistance were observed in patients with NASH newly started on a statin and receiving placebo during the main study. Conclusions: Statin therapy is safe in patients with prediabetes/T2DM and NASH. Given their high cardiovascular risk, statin therapy should be encouraged in this population.

Indexed as

Alanine TransaminaseAspartate AminotransferasesCardiovascular DiseasesDiabetes Mellitus, Type 2DyslipidemiasFemaleGlucose Clamp TechniqueHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypoglycemic AgentsLiverMagnetic Resonance SpectroscopyMaleMiddle AgedNon-alcoholic Fatty Liver DiseasePioglitazoneAlanine TransaminaseAspartate AminotransferasesHydroxymethylglutaryl-CoA Reductase InhibitorsHypoglycemic AgentsPioglitazoneThiazolidinediones

Identifiers

PMID28575232
PMCPMC5546850
OpenAlexW2620954776

What Socratic holds

Texttitle and abstract
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 Socratic graph.