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Empagliflozin Improves Liver Steatosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver Disease and Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Open accessAbstract
INTRODUCTION: To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM). METHODS: In this prospective randomized, double-blind, placebo-controlled trial, we assigned 106 patients with NAFLD and T2DM to receive empagliflozin 10 mg (n = 35), pioglitazone 30 mg (n = 34), or placebo (n = 37) for 24 weeks. Liver fat content and liver stiffness were measured using fibroscans. Body composition assessment was performed by dual-energy x-ray absorptiometry (DEXA) scans. The primary end point was change from baseline in liver steatosis, using the controlled attenuation parameter (CAP) score. RESULTS: A borderline significant decrease in CAP score was observed with empagliflozin compared to placebo, mean difference: - 29.6 dB/m (- 39.5 to - 19.6) versus - 16.4 dB/m (- 25.0 to - 7.8), respectively; p = 0.05. Using multivariate analysis, we observed a significant reduction in the placebo-corrected change in liver stiffness measurement (LSM) with empagliflozin compared to pioglitazone: - 0.77 kPa (- 1.45, - 0.09), p = 0.02, versus 0.01 kPa (95% CI - 0.70, 0.71, p = 0.98), p for comparison = 0.03. Changes in serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT), fasting insulin, homeostatic model assessment for insulin resistance (HOMA-IR), HOMA2-IR, fibrosis-4 index (FIB4 index), NAFLD fibrosis score, aspartate aminotransferase to platelet ratio index (APRI), android/gynecoid ratio (A/G ratio), and skeletal muscle index (SMI) were comparable between the two treatment groups, while significant reductions of the body weight and visceral fat area were observed only in the empagliflozin group (p < 0.001 and p = 0.01, respectively) and both were increased in the placebo and pioglitazone groups. There were no serious adverse events in either group. CONCLUSION: Treatment for 24 weeks with empagliflozin, in contrast to pioglitazone, was associated with improvement of liver steatosis and fibrosis in patients with NAFLD and T2DM. In addition, body weight and abdominal fat area were decreased in the empagliflozin group. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT), IRCT20190122042450N3.
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“Empagliflozin (EMPA), a highly selective inhibitor of sodium-glucose co-transporter 2 (SGLT2), exhibits potential therapeutic benefits for liver steatosis; however, the underlying mechanism remains incompletely elucidated.”
From SGLT2 inhibitor promotes ketogenesis to improve MASH by suppressing CD8+ T cell activation (2024) · cites this paper as [18]
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Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes
Zinman, B., Wanner, C., Lachin, J. M., Fitchett, D., Bluhmki, E., Hantel, S., Mattheus, M., Devins, T., Johansen, O. E., Woerle, H. J., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1504720 · Cited by 12,315
Sterling, R. K., Lissen, E., Clumeck, N., Sola, R., Correa, M. C., Montaner, J., S. Sulkowski, M., Torriani, F. J., Dieterich, D. T., Thomas, D. L., et al. (2006) · Hepatology · doi:10.1002/hep.21178 · Cited by 5,021 · cited 1×
“Furthermore, the FIB-4 (fibrosis 4) index [39] was calculated using the following formula: FIB-4 index = [age 9 AST (units/l)]/(platelet count (9 10(9)/l) 9 [ALT (units/l)].”
Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis
Sanyal, A. J., Chalasani, N., Kowdley, K. V., McCullough, A., Diehl, A. M., Bass, N. M., Neuschwander-Tetri, B. A., Lavine, J. E., Tonascia, J., Unalp, A., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0907929 · Cited by 3,327
Angulo, P., Hui, J. M., Marchesini, G., Bugianesi, E., George, J., Farrell, G. C., Enders, F., Saksena, S., Burt, A. D., Bida, J. P., et al. (2007) · Hepatology · doi:10.1002/hep.21496 · Cited by 3,255
Nonalcoholic Fatty Liver Disease: From Steatosis to Cirrhosis
Farrell, G. C., & Larter, C. Z. (2006) · Hepatology · doi:10.1002/hep.20973 · Cited by 2,428
Risk of Cardiovascular Disease in Patients with Nonalcoholic Fatty Liver Disease
Targher, G., Day, C. P., & Bonora, E. (2010) · New England Journal of Medicine · doi:10.1056/nejmra0912063 · Cited by 1,907
A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis
Belfort, R., Harrison, S. A., Brown, K., Darland, C., Finch, J., Hardies, J., Balas, B., Gastaldelli, A., Tio, F., Pulcini, J., et al. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa060326 · Cited by 1,827
Non-alcoholic fatty liver disease and risk of incident cardiovascular disease: A meta-analysis
Targher, G., Byrne, C. D., Lonardo, A., Zoppini, G., & Barbui, C. (2016) · Journal of Hepatology · doi:10.1016/j.jhep.2016.05.013 · Cited by 1,429
Eddowes, P. J., Sasso, M., Allison, M., Tsochatzis, E. A., Anstee, Q. M., Sheridan, D. A., Guha, I. N., Cobbold, J., Deeks, J. J., Paradis, V., et al. (2019) · Gastroenterology · doi:10.1053/j.gastro.2019.01.042 · Cited by 1,425
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SGLT-2 Inhibitors in NAFLD: Expanding Their Role beyond Diabetes and Cardioprotection
Ανδρουτσάκος, Θ., Ansari, N. N., Bakasis, A., Kyrou, I., EFSTATHOPOULOS, E. P., Randeva, H. S., & Kassi, E. N. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23063107 · Cited by 176
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Metadata
- Authors
- Chehrehgosha, H., Sohrabi, M. R., Ismail-Beigi, F., Malek, M., Reza Babaei, M., Zamani, F., Ajdarkosh, H., Khoonsari, M., Fallah, A. E., & Khamseh, M. E.
- Affiliations
- Iran University of Medical Sciences (IR)
- Corresponding author
- Khamseh, Mohammad E.
- Venue
- Diabetes Therapy
- Published
- 2021-02-14
- Volume
- 12
- Issue
- 3
- Pages
- 843-861
- ISSN
- 1869-6953 (ISSN-L)
- 1869-6961
- PMC
- PMC7882235
- OpenAlex
- W3130225195
- Cited by
- 173
- References
- 86
- Citations by year
- 2026: 22 · 2025: 40 · 2024: 30 · 2023: 47 · 2022: 22 · 2021: 10
- FWCI
- 19.63
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Diabetes Therapy (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- Iran University of Medical Sciences
- Topics
- Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Keywords
- empagliflozin, pioglitazone, non-alcoholic fatty liver disease, type 2 diabetes, hepatic steatosis, liver fibrosis, controlled attenuation parameter, liver stiffness measurement, FibroScan, visceral fat, body composition, insulin resistance, SGLT2 inhibitors, thiazolidinediones, antidiabetic drugs
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