Pilot study of liraglutide effects in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease with glucose intolerance in Japanese patients (LEAN-J)

Yuichiro Eguchi, Yoichiro Kitajima, Hideyuki Hyogo, Hirokazu Takahashi, Motoyasu Kojima, Masafumi Ono, Norimasa Araki, Kenichi Tanaka, Miyuki Yamaguchi, yayoi matsuda, Yasushi Ide, Taiga Otsuka, Iwata Ozaki, Naofumi Ono, Takahisa Eguchi, Keizo Anzai

Research output: Contribution to journalArticle

47 Citations (Scopus)

Abstract

Aim: Non-alcoholic fatty liver disease (NAFLD), a hepatic manifestation of metabolic syndrome, is associated with an increased risk of developing lifestyle-related diseases including type 2 diabetes, cardiovascular disease and cerebral vessel disease. No current drug therapy provides the ideal effects of decreasing hepatic inflammation while simultaneously improving liver fibrosis. Liraglutide is a glucagon-like peptide-1 receptor agonist that affects the histological findings in patients with non-alcoholic steatohepatitis (NASH). This study was conducted to evaluate the effect and action of liraglutide for biopsy-proven NASH. Methods: After lifestyle modification intervention for 24 weeks, subjects whose hemoglobin A1c levels failed to improve to less than 6.0% and/or whose alanine aminotransferase levels were not lower than baseline, received liraglutide at 0.9mg/body per day for 24weeks. Results: Of 27 subjects, 26 completed the lifestyle modification intervention. Nineteen subjects received liraglutide therapy for 24weeks. Body mass index, visceral fat accumulation, aminotransferases and glucose abnormalities improved significantly. Repeated liver biopsy was performed in 10 subjects who continued liraglutide therapy for 96 weeks. Six subjects showed decreased histological inflammation as determined by NASH activity score and stage determined by Brunt classification. We saw no significant adverse events during therapy with liraglutide. Conclusion: Our pilot study demonstrated that treatment with liraglutide had a good safety profile and significantly improved liver function and histological features in NASH patients with glucose intolerance.

Original languageEnglish
Pages (from-to)269-278
Number of pages10
JournalHepatology Research
Volume45
Issue number3
DOIs
Publication statusPublished - Jan 1 2015
Externally publishedYes

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Glucose Intolerance
Fatty Liver
Life Style
Liver
Inflammation
Biopsy
Intra-Abdominal Fat
Therapeutics
Transaminases
Non-alcoholic Fatty Liver Disease
Liraglutide
Alanine Transaminase
Liver Cirrhosis
Type 2 Diabetes Mellitus
Hemoglobins
Body Mass Index
Cardiovascular Diseases
Safety
Glucose
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Infectious Diseases

Cite this

Pilot study of liraglutide effects in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease with glucose intolerance in Japanese patients (LEAN-J). / Eguchi, Yuichiro; Kitajima, Yoichiro; Hyogo, Hideyuki; Takahashi, Hirokazu; Kojima, Motoyasu; Ono, Masafumi; Araki, Norimasa; Tanaka, Kenichi; Yamaguchi, Miyuki; matsuda, yayoi; Ide, Yasushi; Otsuka, Taiga; Ozaki, Iwata; Ono, Naofumi; Eguchi, Takahisa; Anzai, Keizo.

In: Hepatology Research, Vol. 45, No. 3, 01.01.2015, p. 269-278.

Research output: Contribution to journalArticle

Eguchi, Y, Kitajima, Y, Hyogo, H, Takahashi, H, Kojima, M, Ono, M, Araki, N, Tanaka, K, Yamaguchi, M, matsuda, Y, Ide, Y, Otsuka, T, Ozaki, I, Ono, N, Eguchi, T & Anzai, K 2015, 'Pilot study of liraglutide effects in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease with glucose intolerance in Japanese patients (LEAN-J)', Hepatology Research, vol. 45, no. 3, pp. 269-278. https://doi.org/10.1111/hepr.12351
Eguchi, Yuichiro ; Kitajima, Yoichiro ; Hyogo, Hideyuki ; Takahashi, Hirokazu ; Kojima, Motoyasu ; Ono, Masafumi ; Araki, Norimasa ; Tanaka, Kenichi ; Yamaguchi, Miyuki ; matsuda, yayoi ; Ide, Yasushi ; Otsuka, Taiga ; Ozaki, Iwata ; Ono, Naofumi ; Eguchi, Takahisa ; Anzai, Keizo. / Pilot study of liraglutide effects in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease with glucose intolerance in Japanese patients (LEAN-J). In: Hepatology Research. 2015 ; Vol. 45, No. 3. pp. 269-278.
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T1 - Pilot study of liraglutide effects in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease with glucose intolerance in Japanese patients (LEAN-J)

AU - Eguchi, Yuichiro

AU - Kitajima, Yoichiro

AU - Hyogo, Hideyuki

AU - Takahashi, Hirokazu

AU - Kojima, Motoyasu

AU - Ono, Masafumi

AU - Araki, Norimasa

AU - Tanaka, Kenichi

AU - Yamaguchi, Miyuki

AU - matsuda, yayoi

AU - Ide, Yasushi

AU - Otsuka, Taiga

AU - Ozaki, Iwata

AU - Ono, Naofumi

AU - Eguchi, Takahisa

AU - Anzai, Keizo

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Aim: Non-alcoholic fatty liver disease (NAFLD), a hepatic manifestation of metabolic syndrome, is associated with an increased risk of developing lifestyle-related diseases including type 2 diabetes, cardiovascular disease and cerebral vessel disease. No current drug therapy provides the ideal effects of decreasing hepatic inflammation while simultaneously improving liver fibrosis. Liraglutide is a glucagon-like peptide-1 receptor agonist that affects the histological findings in patients with non-alcoholic steatohepatitis (NASH). This study was conducted to evaluate the effect and action of liraglutide for biopsy-proven NASH. Methods: After lifestyle modification intervention for 24 weeks, subjects whose hemoglobin A1c levels failed to improve to less than 6.0% and/or whose alanine aminotransferase levels were not lower than baseline, received liraglutide at 0.9mg/body per day for 24weeks. Results: Of 27 subjects, 26 completed the lifestyle modification intervention. Nineteen subjects received liraglutide therapy for 24weeks. Body mass index, visceral fat accumulation, aminotransferases and glucose abnormalities improved significantly. Repeated liver biopsy was performed in 10 subjects who continued liraglutide therapy for 96 weeks. Six subjects showed decreased histological inflammation as determined by NASH activity score and stage determined by Brunt classification. We saw no significant adverse events during therapy with liraglutide. Conclusion: Our pilot study demonstrated that treatment with liraglutide had a good safety profile and significantly improved liver function and histological features in NASH patients with glucose intolerance.

AB - Aim: Non-alcoholic fatty liver disease (NAFLD), a hepatic manifestation of metabolic syndrome, is associated with an increased risk of developing lifestyle-related diseases including type 2 diabetes, cardiovascular disease and cerebral vessel disease. No current drug therapy provides the ideal effects of decreasing hepatic inflammation while simultaneously improving liver fibrosis. Liraglutide is a glucagon-like peptide-1 receptor agonist that affects the histological findings in patients with non-alcoholic steatohepatitis (NASH). This study was conducted to evaluate the effect and action of liraglutide for biopsy-proven NASH. Methods: After lifestyle modification intervention for 24 weeks, subjects whose hemoglobin A1c levels failed to improve to less than 6.0% and/or whose alanine aminotransferase levels were not lower than baseline, received liraglutide at 0.9mg/body per day for 24weeks. Results: Of 27 subjects, 26 completed the lifestyle modification intervention. Nineteen subjects received liraglutide therapy for 24weeks. Body mass index, visceral fat accumulation, aminotransferases and glucose abnormalities improved significantly. Repeated liver biopsy was performed in 10 subjects who continued liraglutide therapy for 96 weeks. Six subjects showed decreased histological inflammation as determined by NASH activity score and stage determined by Brunt classification. We saw no significant adverse events during therapy with liraglutide. Conclusion: Our pilot study demonstrated that treatment with liraglutide had a good safety profile and significantly improved liver function and histological features in NASH patients with glucose intolerance.

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