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Randomized, Placebo-Controlled Trial of Pioglitazone in Nondiabetic Subjects With Nonalcoholic Steatohepatitis
Open accessAbstract
Background & aims Nonalcoholic steatohepatitis (NASH) is a leading cause of chronic liver disease for which there is limited therapy available. Insulin sensitizing, anti-inflammatory, and antifibrotic properties of thiazolidinediones support their use in treating NASH. We have evaluated pioglitazone in the treatment of nondiabetic patients with NASH.Methods We randomized 74 nondiabetic patients (45 men; median age, 54 y) with histologically proven NASH to 12 months of standard diet, exercise, and either placebo or pioglitazone (30 mg/day). Sixty-one patients (30 placebo, 31 pioglitazone) had liver biopsies both at the beginning and the end of the study.Results Compared with placebo, pioglitazone therapy was associated with an increase in weight (mean change, -0.55 vs +2.77 kg; P = .04) and a reduction in glucose (+0.4 vs -0.1 mmol/L; P = .02), HbA1c (+0.16% vs -0.18%; P = .006), insulin C peptide level (+42 vs -78 pmol/L; P = .02), alanine aminotransferase level (-10.9 vs -36.2 u/L; P = .009), gamma-glutamyltransferase level (-9.4 vs -41.2 u/L; P = .002), and ferritin (-11.3 vs -90.5 microg/L; P = .01). Histologic features including hepatocellular injury (P = .005), Mallory-Denk bodies (P = .004), and fibrosis (P = .05) were reduced in patients treated with pioglitazone compared with those in the placebo group.Conclusions Pioglitazone therapy over a 12-month period in nondiabetic subjects with NASH resulted in improvements in metabolic and histologic parameters, most notably liver injury and fibrosis. Larger extended trials are justified to assess the long-term efficacy of pioglitazone in this patient group.
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“A meta-analysis of 8 RCTs in people with biopsy-proven MASH concluded that pioglitazone was not only associated with the improvement of MASH but also reversal of fibrosis, irrespective of the presence of type 2 diabetes [178].”
From Obesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease? (2024) · cites this paper as [178]
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“Histological analysis revealed significant reductions in hepatocellular injury, Mallory–Denk bodies, and fibrosis compared with placebo.”
From Strategies to promote liver fibrosis amelioration with involvement of restorative macrophages (2026) · cites this paper as [203]
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“In several RCTs, pioglitazone, a thiazolidinedione which mainly activates peroxisome proliferator-activated receptor (PPAR) c , has been shown to improve histological features of steatohepatitis, 372,418 -420 without a clear effect on fi brosis regression even after prolonged (3-year) therapy.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [418]
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“evidence showing that long-term PIO is associated with histological improvement of NASH, a significant reduction of intrahepatic triglyceride content, improvement of insulin sensitivity across all tissues, and better glycaemic control.(1-3,9) In our cohort,(1) 18 months of treatment with PIO resulted in a placebo-subt…”
BackgroundNon-Alcoholic Fatty Liver Disease (NAFLD): The Search for a Cure
Alabagi, A., Reynolds, C. A., & A‐Kader, H. H. (2016) · European Medical Journal · doi:10.33590/emj/10314771 · Cited by 3
Treatment of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH)
Bril, F., Ntim, K., Lomonaco, R., & Cusi, K. J. (2015) · Wiley eBooks · doi:10.1002/9781118387658.ch20 · Cited by 3
Podszun, M. C., Alawad, A. S., Lingala, S., Morris, N., Huang, W. C. A., & Rotman, Y. (2025) · Journal of Dietary Supplements · doi:10.1080/19390211.2025.2465414 · Cited by 2
“However, treatment-induced improvements do not lead to ferritin levels below the normal range (Aithal et al. 2008).”
Tran, Q. T., Bui, T. T., Ngo, L. T., Yang, B. R., Baek, I., Nguyen, V. H., Lee, K. A., Yun, H., Chae, J., Lee, S., et al. (2025) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.70034 · Cited by 3
PPARidgm shifts in the treatment of metabolic dysfunction–associated steatotic liver disease
Abushamat, L. A., & Barb, D. (2025) · Hepatology · doi:10.1097/hep.0000000000001511 · Cited by 2
Wood, E. M., Akande, R. O., Iqbal, I., & Albert, S. G. (2025) · Diabetes Obesity and Metabolism · doi:10.1111/dom.70314 · Cited by 2
Treating the patient with nonalcoholic fatty liver disease
Chaney, A. J. (2015) · The Nurse Practitioner · doi:10.1097/01.npr.0000472248.28703.18 · Cited by 2
Antidiabetic Treatments for Diabetes with Liver Cirrhosis
Sumida, Y. (2020) · Interventions in Obesity & Diabetes · doi:10.31031/iod.2020.03.000566 · Cited by 2
“Although the efficacy of GLP-1 RA for cirrhosis is unknown, it can be the first choice, especially for NASH cirrhosis, based on results such as cardiorenal protection (LEADER trial, AWARD10 study, and SUSUATIN 6 study).”
BackgroundInfluentialD’Souza, S. M., Yoo Byung, S., Houston, K. V., Patel, A., Parekh, P. J., & Johnson, D. A. (2021) · Annals of Clinical Gastroenterology and Hepatology · doi:10.29328/journal.acgh.1001030 · Cited by 2
Clinical and Basic Biology of Werner Syndrome, the Model Disease of Human Aging
Maezawa, Y., Koshizaka, M., Kato, H., & Yokote, K. (2022) · Springer eBooks · doi:10.1007/978-981-16-7977-3_2 · Cited by 2
Mohamed Anasdeen, S., Shahinaz, S., & Vijayakumar, T. M. (2024) · Cureus · doi:10.7759/cureus.67151 · Cited by 3
“It is often limited by its side effects, including weight gain [4,5].”
BackgroundHepatogenic diabetes: three cases report and literature review
Amosova, M., Poluboyarinova, I. V., Владимировна, С. П., Zherebchikova, K., & Fadeev, V. V. (2025) · Problems of Endocrinology · doi:10.14341/probl13443 · Cited by 2
“В нескольких рандомизированных исследовани-ях было показано положительное влияние ТЗД на тече-ние НАЖБП, в частности под влиянием пиоглитазона существенно улучшалась гистопатологическая картина печени [19, 20].”
Ahmad, J. (2010) · Springer eBooks · doi:10.1007/978-1-4419-7085-5_1 · Cited by 2
Pharmacological agents for nonalcoholic steatohepatitis
Guillaume, M., & Ratziu, V. (2013) · Hepatology International · doi:10.1007/s12072-013-9482-8 · Cited by 2
“In controlled clinical trials, pioglitazone improved aminotransferase levels and histological features of liver injury (including resolution of steatohepatitis), except for fibrosis, in NASH patients with insulin resistance or T2DM [17], but also in nondiabetic NASH patients [18, 19].”
Background1. Nonalcoholic Fatty Liver Disease
Takamura, T. (2013) · Nihon Naika Gakkai Zasshi · doi:10.2169/naika.102.836 · Cited by 3
Dealing with abnormal test results in diabetes
Morris, D., & Morris, S. (2016) · Independent Nurse · doi:10.12968/indn.2016.12.22 · Cited by 2
Drug-Induced Fatty Liver Disease
Samala, N. R., & Chalasani, N. (2018) · Current Hepatology Reports · doi:10.1007/s11901-018-0418-6 · Cited by 2
Advances in the treatment of nonalcoholic steatohepatitis
Mukherjee, S. (2020) · World Journal of Pharmacology · doi:10.5497/wjp.v9.i1.1 · Cited by 2
Association of insulin resistance and non-alcoholic fatty liver disease
Mishina, E. Е., Mayorov, A. Y., Bogomolov, P., Liusina, E. O., & Bueverov, A. O. (2021) · Diabetes Mellitus · doi:10.14341/dm12234 · Cited by 2
Metadata
- Authors
- Aithal, G. P., Thomas, J. A., Kaye, P. V., Lawson, A., Ryder, S. D., Spendlove, I., Austin, A. S., Freeman, J. G., Morgan, L., & Webber, J.
- Affiliations
- Nottingham University Hospitals NHS Trust (GB)
- University of Nottingham (GB)
- Royal Derby Hospital (GB)
- University Hospitals Birmingham NHS Foundation Trust (GB)
- Corresponding author
- Aithal, Guruprasad P.
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2008-10
- Volume
- 135
- Issue
- 4
- Pages
- 1176-1184
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2151490108
- Cited by
- 721
- References
- 39
- Citations by year
- 2026: 15 · 2025: 33 · 2024: 34 · 2023: 38 · 2022: 51 · 2021: 54 · 2020: 48 · 2019: 35 · 2018: 34 · 2017: 36 · 2016: 45 · 2015: 42 · 2014: 40 · 2013: 38 · 2012: 35
- FWCI
- 35.00
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Keywords
- pioglitazone, nonalcoholic steatohepatitis, thiazolidinediones, non-diabetic patients, liver fibrosis, liver histopathology, insulin sensitivity, insulin resistance, hepatocyte injury, Mallory-Denk bodies, alanine aminotransferase, ferritin, weight change, glycemic control
- MeSH terms
- Pioglitazone, Adult, Aged, Alkaline Phosphatase, Fatty Liver, Female, Humans, Hypoglycemic Agents, Insulin, Liver, Liver Cirrhosis, Male, Middle Aged, Patient Dropouts, Placebos, Treatment Outcome, Thiazolidinediones, Adipokines
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