Lobeglitazone, a novel thiazolidinedione, improves non-alcoholic fatty liver disease in type 2 diabetes: Its efficacy and predictive factors related to responsiveness

Yong Ho Lee, Jae Hyeon Kim, So Ra Kim, Heung Yong Jin, Eun Jung Rhee, Young Min Cho, Byung Wan Lee

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Despite the rapidly increasing prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes (T2D), few treatment modalities are currently available. We investigated the hepatic effects of the novel thiazolidinedione (TZDs), lobeglitazone (Duvie) in T2D patients with NAFLD. We recruited drug-naïve or metformin-treated T2D patients with NAFLD to conduct a multicenter, prospective, open-label, exploratory clinical trial. Transient liver elastography (Fibroscan®; Echosens, Paris, France) with controlled attenuation parameter (CAP) was used to non-invasively quantify hepatic fat contents. Fifty patients with CAP values above 250 dB/m were treated once daily with 0.5 mg lobeglitazone for 24 weeks. The primary endpoint was a decline in CAP values, and secondary endpoints included changes in components of glycemic, lipid, and liver profiles. Lobeglitazone-treated patients showed significantly decreased CAP values (313.4 dB/m at baseline vs. 297.8 dB/m at 24 weeks; P=0.016), regardless of glycemic control. Lobeglitazone improved HbA1C values (7.41% [57.5 mM/M] vs. 6.56% [48.2 mM/M]; P < 0.001), as well as the lipid and liver profiles of the treated patients. Moreover, multivariable linear regression analysis showed that hepatic fat reduction by lobeglitazone was independently associated with baseline values of CAP, liver stiffness, and liver enzymes, and metformin use. Lobeglitazone treatment reduced intrahepatic fat content, as assessed by transient liver elastography, and improved glycemic, liver, and lipid profiles in T2D patients with NAFLD. Further randomized controlled trials using liver histology as an end point are necessary to evaluate the efficacy of lobeglitazone for NAFLD treatment (Clinical trial No. NCT02285205).

Original languageEnglish
Pages (from-to)60-69
Number of pages10
JournalJournal of Korean medical science
Volume32
Issue number1
DOIs
Publication statusPublished - 2017 Jan 1

Fingerprint

Type 2 Diabetes Mellitus
Liver
Elasticity Imaging Techniques
Metformin
Fats
Lipids
2,4-thiazolidinedione
lobeglitazone
Non-alcoholic Fatty Liver Disease
Clinical Trials
Paris
France
Linear Models
Histology
Therapeutics
Randomized Controlled Trials
Regression Analysis
Enzymes

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

@article{c9ddc6a0efcd4924ae35f229888b6edf,
title = "Lobeglitazone, a novel thiazolidinedione, improves non-alcoholic fatty liver disease in type 2 diabetes: Its efficacy and predictive factors related to responsiveness",
abstract = "Despite the rapidly increasing prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes (T2D), few treatment modalities are currently available. We investigated the hepatic effects of the novel thiazolidinedione (TZDs), lobeglitazone (Duvie) in T2D patients with NAFLD. We recruited drug-na{\"i}ve or metformin-treated T2D patients with NAFLD to conduct a multicenter, prospective, open-label, exploratory clinical trial. Transient liver elastography (Fibroscan{\circledR}; Echosens, Paris, France) with controlled attenuation parameter (CAP) was used to non-invasively quantify hepatic fat contents. Fifty patients with CAP values above 250 dB/m were treated once daily with 0.5 mg lobeglitazone for 24 weeks. The primary endpoint was a decline in CAP values, and secondary endpoints included changes in components of glycemic, lipid, and liver profiles. Lobeglitazone-treated patients showed significantly decreased CAP values (313.4 dB/m at baseline vs. 297.8 dB/m at 24 weeks; P=0.016), regardless of glycemic control. Lobeglitazone improved HbA1C values (7.41{\%} [57.5 mM/M] vs. 6.56{\%} [48.2 mM/M]; P < 0.001), as well as the lipid and liver profiles of the treated patients. Moreover, multivariable linear regression analysis showed that hepatic fat reduction by lobeglitazone was independently associated with baseline values of CAP, liver stiffness, and liver enzymes, and metformin use. Lobeglitazone treatment reduced intrahepatic fat content, as assessed by transient liver elastography, and improved glycemic, liver, and lipid profiles in T2D patients with NAFLD. Further randomized controlled trials using liver histology as an end point are necessary to evaluate the efficacy of lobeglitazone for NAFLD treatment (Clinical trial No. NCT02285205).",
author = "Lee, {Yong Ho} and Kim, {Jae Hyeon} and Kim, {So Ra} and Jin, {Heung Yong} and Rhee, {Eun Jung} and Cho, {Young Min} and Lee, {Byung Wan}",
year = "2017",
month = "1",
day = "1",
doi = "10.3346/jkms.2017.32.1.60",
language = "English",
volume = "32",
pages = "60--69",
journal = "Journal of Korean Medical Science",
issn = "1011-8934",
publisher = "Korean Academy of Medical Science",
number = "1",

}

Lobeglitazone, a novel thiazolidinedione, improves non-alcoholic fatty liver disease in type 2 diabetes : Its efficacy and predictive factors related to responsiveness. / Lee, Yong Ho; Kim, Jae Hyeon; Kim, So Ra; Jin, Heung Yong; Rhee, Eun Jung; Cho, Young Min; Lee, Byung Wan.

In: Journal of Korean medical science, Vol. 32, No. 1, 01.01.2017, p. 60-69.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Lobeglitazone, a novel thiazolidinedione, improves non-alcoholic fatty liver disease in type 2 diabetes

T2 - Its efficacy and predictive factors related to responsiveness

AU - Lee, Yong Ho

AU - Kim, Jae Hyeon

AU - Kim, So Ra

AU - Jin, Heung Yong

AU - Rhee, Eun Jung

AU - Cho, Young Min

AU - Lee, Byung Wan

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Despite the rapidly increasing prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes (T2D), few treatment modalities are currently available. We investigated the hepatic effects of the novel thiazolidinedione (TZDs), lobeglitazone (Duvie) in T2D patients with NAFLD. We recruited drug-naïve or metformin-treated T2D patients with NAFLD to conduct a multicenter, prospective, open-label, exploratory clinical trial. Transient liver elastography (Fibroscan®; Echosens, Paris, France) with controlled attenuation parameter (CAP) was used to non-invasively quantify hepatic fat contents. Fifty patients with CAP values above 250 dB/m were treated once daily with 0.5 mg lobeglitazone for 24 weeks. The primary endpoint was a decline in CAP values, and secondary endpoints included changes in components of glycemic, lipid, and liver profiles. Lobeglitazone-treated patients showed significantly decreased CAP values (313.4 dB/m at baseline vs. 297.8 dB/m at 24 weeks; P=0.016), regardless of glycemic control. Lobeglitazone improved HbA1C values (7.41% [57.5 mM/M] vs. 6.56% [48.2 mM/M]; P < 0.001), as well as the lipid and liver profiles of the treated patients. Moreover, multivariable linear regression analysis showed that hepatic fat reduction by lobeglitazone was independently associated with baseline values of CAP, liver stiffness, and liver enzymes, and metformin use. Lobeglitazone treatment reduced intrahepatic fat content, as assessed by transient liver elastography, and improved glycemic, liver, and lipid profiles in T2D patients with NAFLD. Further randomized controlled trials using liver histology as an end point are necessary to evaluate the efficacy of lobeglitazone for NAFLD treatment (Clinical trial No. NCT02285205).

AB - Despite the rapidly increasing prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes (T2D), few treatment modalities are currently available. We investigated the hepatic effects of the novel thiazolidinedione (TZDs), lobeglitazone (Duvie) in T2D patients with NAFLD. We recruited drug-naïve or metformin-treated T2D patients with NAFLD to conduct a multicenter, prospective, open-label, exploratory clinical trial. Transient liver elastography (Fibroscan®; Echosens, Paris, France) with controlled attenuation parameter (CAP) was used to non-invasively quantify hepatic fat contents. Fifty patients with CAP values above 250 dB/m were treated once daily with 0.5 mg lobeglitazone for 24 weeks. The primary endpoint was a decline in CAP values, and secondary endpoints included changes in components of glycemic, lipid, and liver profiles. Lobeglitazone-treated patients showed significantly decreased CAP values (313.4 dB/m at baseline vs. 297.8 dB/m at 24 weeks; P=0.016), regardless of glycemic control. Lobeglitazone improved HbA1C values (7.41% [57.5 mM/M] vs. 6.56% [48.2 mM/M]; P < 0.001), as well as the lipid and liver profiles of the treated patients. Moreover, multivariable linear regression analysis showed that hepatic fat reduction by lobeglitazone was independently associated with baseline values of CAP, liver stiffness, and liver enzymes, and metformin use. Lobeglitazone treatment reduced intrahepatic fat content, as assessed by transient liver elastography, and improved glycemic, liver, and lipid profiles in T2D patients with NAFLD. Further randomized controlled trials using liver histology as an end point are necessary to evaluate the efficacy of lobeglitazone for NAFLD treatment (Clinical trial No. NCT02285205).

UR - http://www.scopus.com/inward/record.url?scp=85008173539&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85008173539&partnerID=8YFLogxK

U2 - 10.3346/jkms.2017.32.1.60

DO - 10.3346/jkms.2017.32.1.60

M3 - Article

C2 - 27914133

AN - SCOPUS:85008173539

VL - 32

SP - 60

EP - 69

JO - Journal of Korean Medical Science

JF - Journal of Korean Medical Science

SN - 1011-8934

IS - 1

ER -