Efficacy and safety of anti-hyperglycaemic drugs in patients with non-alcoholic fatty liver disease with or without diabetes: An updated systematic review of randomized controlled trials
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Aim There are no approved drugs for the treatment of non-alcoholic fatty liver disease (NAFLD). However, many randomized controlled trials (RCT) have examined the effect of anti-hyperglycaemic agents on NAFLD in patients with and without type 2 diabetes mellitus (T2DM), since both T2DM and insulin resistance are closely linked to this burdensome liver disease.Methods We systematically searched publication databases using predefined keywords to identify head-to-head or placebo-controlled RCTs (published until September 30, 2019) of NAFLD individuals testing the efficacy of anti-hyperglycaemic drugs to specifically treat NAFLD or non-alcoholic steatohepatitis (NASH). Outcomes of interest included changes in serum liver enzyme levels, liver fat, liver fibrosis, or histologic resolution of NASH.Results We included 29 RCTs involving a total of 2,617 individuals (∼45% had T2DM) that have used metformin (n=6 studies), glitazones (n=8 studies), glucagon-like peptide-1 receptor agonists (n=6 studies), dipeptidyl peptidase-4 inhibitors (n=4 studies) or sodium-glucose cotransporter-2 inhibitors (n=7 studies) to treat NAFLD. Although most anti-hyperglycaemic drugs improved serum liver enzyme levels, only glitazones (especially pioglitazone) and liraglutide showed an improvement of histologic features of NAFLD, with a mild beneficial effect also on liver fibrosis for pioglitazone only.Conclusion RCT evidence supports the efficacy of some anti-hyperglycaemic agents (especially pioglitazone) in patients with NAFLD or NASH, though weight gain with pioglitazone may warrant caution. Further well-designed RCTs are needed to better characterize the efficacy and safety of monotherapy and combination therapy with anti-hyperglycaemic agents in patients with NAFLD.
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Pioglitazone therapy, GLP-1 RA therapy, and metabolic surgery have all been shown to reduce NASH activity; pioglitazone therapy and metabolic surgery may also improve hepatic fibrosis.
“Pioglitazone therapy, GLP-1 RA therapy, and metabolic surgery have all been shown to reduce NASH activity; pioglitazone therapy and metabolic surgery may also improve hepatic fi brosis (188,292 -298).”
From Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2022) · cites this paper as [295]
The Discussion (page not provided) reports NASH resolution with pioglitazone and with the GLP-1 receptor agonist liraglutide in the LEAN trial. It also reports possible fibrosis improvement with pioglitazone, while describing its overall fibrosis effect as modest. The cited review does not address metabolic surgery, so it does not support the surgery-related parts of the sentence. (LLM, conf=0.88)
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- Authors
- Mantovani, A., Byrne, C. D., Scorletti, E., Mantzoros, C. S., & Targher, G.
- Affiliations
- Azienda Ospedaliera Universitaria Integrata Verona (IT)
- Southampton General Hospital (GB)
- Beth Israel Deaconess Medical Center (US)
- Corresponding author
- Mantovani, A.
- Venue
- Diabetes & Metabolism
- Publisher
- Elsevier BV
- Published
- 2020-11
- Volume
- 46
- Issue
- 6
- Pages
- 427-441
- ISSN
- 1262-3636 (ISSN-L)
- OpenAlex
- W2999845688
- Cited by
- 138
- References
- 54
- Citations by year
- 2026: 7 · 2025: 24 · 2024: 21 · 2023: 22 · 2022: 18 · 2021: 29 · 2020: 16
- FWCI
- 3.10
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- Diabetes & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- ePrints Soton (University of Southampton) (acceptedVersion)
- Funders
- NIHR Biomedical Research Centre, Royal Marsden NHS Foundation Trust/Institute of Cancer Research
- National Institute for Health and Care Research
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, type 2 diabetes, metformin, thiazolidinediones, pioglitazone, GLP-1 receptor agonists, liraglutide, DPP-4 inhibitors, SGLT2 inhibitors, insulin resistance, liver fibrosis, liver fat, weight gain
- MeSH terms
- Glucagon-Like Peptide-1 Receptor, Sodium-Glucose Transporter 2 Inhibitors, Glucagon-Like Peptide-1 Receptor Agonists, Diabetes Mellitus, Type 2, Humans, Hypoglycemic Agents, Metformin, Randomized Controlled Trials as Topic, Treatment Outcome, Thiazolidinediones, Dipeptidyl-Peptidase IV Inhibitors, Non-alcoholic Fatty Liver Disease
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