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

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 recei...

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Published inDiabetes therapy Vol. 12; no. 3; pp. 843 - 861
Main Authors 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.
Format Journal Article
LanguageEnglish
Published Cheshire Springer Healthcare 01.03.2021
Springer
Springer Nature B.V
Subjects
Antidiabetics
Cardiology
Diabetes
Double-blind studies
Drug therapy
Endocrinology
Fatty liver
Hepatitis
Insulin
Internal Medicine
Liver diseases
Medicine
Medicine & Public Health
Original Research
Patient outcomes
Type 2 diabetes
Iran
Empagliflozin
Nonalcoholic steato-hepatitis (NASH)
Pioglitazone
Fibroscan
Non-alcoholic fatty liver disease (NAFLD)
Liver fibrosis
Body composition
Steatosis
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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.
AbstractList To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM). 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. 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. 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.
To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM). 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. 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. 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. Iranian Registry of Clinical Trials (IRCT), IRCT20190122042450N3.
IntroductionTo evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM).MethodsIn 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.ResultsA 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.ConclusionTreatment 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 RegistrationIranian Registry of Clinical Trials (IRCT), IRCT20190122042450N3.
To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM).INTRODUCTIONTo evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM).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.METHODSIn 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.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.RESULTSA 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.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.CONCLUSIONTreatment 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.Iranian Registry of Clinical Trials (IRCT), IRCT20190122042450N3.TRIAL REGISTRATIONIranian Registry of Clinical Trials (IRCT), IRCT20190122042450N3.
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.
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.
Audience Academic
Author Reza Babaei, Mohammad
Fallah, Afshin Eshghi
Ajdarkosh, Hossein
Sohrabi, Masoud Reza
Malek, Mojtaba
Zamani, Farhad
Khoonsari, Mahmood
Ismail-Beigi, Faramarz
Khamseh, Mohammad E.
Chehrehgosha, Haleh
Author_xml – sequence: 1
  givenname: Haleh
  surname: Chehrehgosha
  fullname: Chehrehgosha, Haleh
  organization: Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS)
– sequence: 2
  givenname: Masoud Reza
  surname: Sohrabi
  fullname: Sohrabi, Masoud Reza
  organization: Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS)
– sequence: 3
  givenname: Faramarz
  surname: Ismail-Beigi
  fullname: Ismail-Beigi, Faramarz
  organization: Department of Medicine, Case Western Reserve University, University Hospitals Cleveland Medical Center
– sequence: 4
  givenname: Mojtaba
  surname: Malek
  fullname: Malek, Mojtaba
  organization: Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS)
– sequence: 5
  givenname: Mohammad
  surname: Reza Babaei
  fullname: Reza Babaei, Mohammad
  organization: Department of Interventional Radiology, Firouzgar Hospital, Iran University of Medical Sciences (IUMS)
– sequence: 6
  givenname: Farhad
  surname: Zamani
  fullname: Zamani, Farhad
  organization: Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS)
– sequence: 7
  givenname: Hossein
  surname: Ajdarkosh
  fullname: Ajdarkosh, Hossein
  organization: Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS)
– sequence: 8
  givenname: Mahmood
  surname: Khoonsari
  fullname: Khoonsari, Mahmood
  organization: Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS)
– sequence: 9
  givenname: Afshin Eshghi
  surname: Fallah
  fullname: Fallah, Afshin Eshghi
  organization: Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS)
– sequence: 10
  givenname: Mohammad E.
  orcidid: 0000-0003-4313-8440
  surname: Khamseh
  fullname: Khamseh, Mohammad E.
  email: khamseh.m@iums.ac.ir
  organization: Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS)
BackLink https://www.ncbi.nlm.nih.gov/pubmed/33586120$$D View this record in MEDLINE/PubMed
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Issue 3
Keywords Empagliflozin
Nonalcoholic steato-hepatitis (NASH)
Pioglitazone
Fibroscan
Non-alcoholic fatty liver disease (NAFLD)
Liver fibrosis
Body composition
Steatosis
Language English
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Snippet Introduction To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes...
To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM). In...
Introduction To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes...
To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM). In...
IntroductionTo evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes...
To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes...
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SubjectTerms Antidiabetics
Cardiology
Diabetes
Double-blind studies
Drug therapy
Endocrinology
Fatty liver
Hepatitis
Insulin
Internal Medicine
Liver diseases
Medicine
Medicine & Public Health
Original Research
Patient outcomes
Type 2 diabetes
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Title 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
URI https://link.springer.com/article/10.1007/s13300-021-01011-3
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https://www.proquest.com/docview/2512389528
https://www.proquest.com/docview/2489600693
https://pubmed.ncbi.nlm.nih.gov/PMC7882235
Volume 12
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