title: Pilot study of liraglutide effects in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease with glucose intolerance in Japanese patients (LEAN-J).
abstract: OBJECTIVE
  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 0.9 mg/body per day for 24 weeks.
  
  
  RESULTS
  Of 27 subjects, 26 completed the lifestyle modification intervention. Nineteen subjects received liraglutide therapy for 24 weeks. 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Hepatology, Saga Medical School, Saga, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Eguchi
authors.forename: Yoichiro
authors.initials: Y
authors.lastname: Kitajima
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Hyogo
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Takahashi
authors.forename: Motoyasu
authors.initials: M
authors.lastname: Kojima
authors.forename: Masafumi
authors.initials: M
authors.lastname: Ono
authors.forename: Norimasa
authors.initials: N
authors.lastname: Araki
authors.forename: Kenichi
authors.initials: K
authors.lastname: Tanaka
authors.forename: Miyuki
authors.initials: M
authors.lastname: Yamaguchi
authors.forename: Yayoi
authors.initials: Y
authors.lastname: Matsuda
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Ide
authors.forename: Taiga
authors.initials: T
authors.lastname: Otsuka
authors.forename: Iwata
authors.initials: I
authors.lastname: Ozaki
authors.forename: Naofumi
authors.initials: N
authors.lastname: Ono
authors.forename: Takahisa
authors.initials: T
authors.lastname: Eguchi
authors.forename: Keizo
authors.initials: K
authors.lastname: Anzai
keywords: fatty liver; glucagon-like peptide-1; liraglutide; non-alcoholic fatty liver disease; non-alcoholic steatohepatitis; steatohepatitis