Liver safety of statins in prediabetes or T2DM and nonalcoholic steatohepatitis: post hoc analysis of a randomized trial
Open accessAbstract
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.
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The safety of statins has been well established in individuals with MASLD with no increased risk of hepatotoxicity.
“The safety of statins has been well established in individuals with MASLD 389,390 with no increased risk of hepatotoxicity”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [390]
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Crosstalk between Lipids and Non-Alcoholic Fatty Liver Disease
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Targeting THR-β for MASLD Treatment: Current Progression and Emerging Prospects
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Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: Overlapping Mechanisms
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Statin Use in Special Populations for the Prevention of Cardiovascular Disease in Adults
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- Authors
- Bril, F., Portillo Sanchez, P., Lomonaco, R., Orsak, B., Hecht, J., Tio, F., & Cusi, K.
- Affiliations
- University of Florida Health (US)
- The University of Texas at San Antonio Health Science Center (US)
- Audie L. Murphy Memorial VA Hospital (US)
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2017-06-01
- Volume
- 102
- Issue
- 8
- Pages
- 2950-2961
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- PMC
- PMC5546850
- OpenAlex
- W2620954776
- Cited by
- 97
- References
- 52
- Citations by year
- 2026: 7 · 2025: 12 · 2024: 11 · 2023: 14 · 2022: 7 · 2021: 13 · 2020: 6 · 2019: 14 · 2018: 10 · 2017: 3
- FWCI
- 7.07
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Veterans Affairs (I01 CX000167)
- Burroughs Wellcome Fund
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK079626)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Keywords
- statins, hepatotoxicity, nonalcoholic steatohepatitis, prediabetes, type 2 diabetes, liver safety, alanine aminotransferase elevation, hepatic insulin resistance, pioglitazone, cardiovascular risk, non-alcoholic fatty liver disease
- MeSH terms
- Pioglitazone, Alanine Transaminase, Aspartate Aminotransferases, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Female, Humans, Hypoglycemic Agents, Liver, Male, Middle Aged, Magnetic Resonance Spectroscopy, Prediabetic State, Glucose Clamp Technique, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Thiazolidinediones, Dyslipidemias, Non-alcoholic Fatty Liver Disease
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