Cited by 173Liver Disease Diagnosis and TreatmentDiabetes Treatment and ManagementChronic Kidney Disease and Diabetes

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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

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Chehrehgosha, Haleh, Sohrabi, Masoud Reza, Ismail-Beigi, Faramarz, Malek, Mojtaba, Reza Babaei, Mohammad, Zamani, Farhad, Ajdarkosh, Hossein, Khoonsari, Mahmood, Fallah, Afshin Eshghi, Khamseh, Mohammad E.·2021·Diabetes Therapy

DOI 10.1007/s13300-021-01011-3PMC PMC7882235

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Abstract

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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Fig. 1 Patient enrollment flow diagram. ITT intention to treatCC BY-NC · PubMed Central

Fig. 2 a Distribution of CAP score stratified by the study groups. White boxes show the CAP score at baseline, and black ones indicate the final results after the intervention. *p < 0.05 compared with baseline and significant results. b Distribution of liver stiffness measurement stratified by the study groups. White boxes show liver stiffness measurement at baseline, and black ones indicate final results after the intervention.*p < 0.05 compared with baseline and significant resultsCC BY-NC · PubMed Central

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Additional file 4 of Effect of Empagliflozin and Pioglitazone on left ventricular function in patients with type two diabetes and nonalcoholic fatty liver disease without established cardiovascular disease: a randomized single-blind clinical trial
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Additional file 2 of Effect of Empagliflozin and Pioglitazone on left ventricular function in patients with type two diabetes and nonalcoholic fatty liver disease without established cardiovascular disease: a randomized single-blind clinical trial
Attaran, F., Emami, S., Sohrabi, M., Malek, M., Ajdarkosh, H., Khoonsari, M., Ismail‐Beigi, F., & Khamseh, M. E. (2023) · Figshare · doi:10.6084/m9.figshare.24187885
Self-citation
Additional file 3 of Effect of Empagliflozin and Pioglitazone on left ventricular function in patients with type two diabetes and nonalcoholic fatty liver disease without established cardiovascular disease: a randomized single-blind clinical trial
Attaran, F., Emami, S., Sohrabi, M., Malek, M., Ajdarkosh, H., Khoonsari, M., Ismail‐Beigi, F., & Khamseh, M. E. (2023) · Figshare · doi:10.6084/m9.figshare.24187888
Self-citation
Additional file 1 of Effect of Empagliflozin and Pioglitazone on left ventricular function in patients with type two diabetes and nonalcoholic fatty liver disease without established cardiovascular disease: a randomized single-blind clinical trial
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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.
ORCID: Chehrehgosha, Haleh
Malek, Mojtaba
Zamani, Farhad
Ajdarkosh, Hossein
Khamseh, Mohammad E.
Venue: Diabetes Therapy
Publisher: Springer Science and Business Media LLC
Published: 2021-02-14
Volume: 12
Issue: 3
Pages: 843-861
ISSN: 1869-6953 (ISSN-L)
1869-6961
DOI: 10.1007/s13300-021-01011-3
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: cc-by-nc
creativecommons.org/licenses/by-nc/4.0 (tdm)
creativecommons.org/licenses/by-nc/4.0 (vor)
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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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

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