title: Efficacy of ezetimibe for the treatment of non-alcoholic steatohepatitis: An open-label, pilot study.
abstract: OBJECTIVE
  Non-alcoholic steatohepatitis (NASH) is considered a hepatic manifestation of metabolic syndrome. However, effective drug therapy for NASH has not been established yet. In the present study, we evaluated the efficacy of 6 months of ezetimibe treatment for NASH patients with dyslipidemia for the comparison of improvement of the clinical parameters and histological alterations.
  
  
  METHODS
  We prospectively evaluated 10 consecutive NASH patients with dyslipidemia who agreed to participate in this study. The patients were given ezetimibe (10 mg/day) for 6 months, and clinical parameters and histological alterations were comparatively evaluated before and after treatment. All the patients were given standard calorie diet (30 kcal/kg per day, carbohydrate 50-60%, fat 20-30%, protein 15-20%) and exercise counseling from 3 months before the ezetimibe treatment.
  
  
  RESULTS
  The serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, low-density lipoprotein cholesterol, high-sensitivity C-reactive protein and type IV collagen 7 s levels were significantly improved by the treatment with ezetimibe for 6 months. In histological observations, follow-up liver biopsies revealed that the NAS score and steatosis grade were also significantly improved. The fibrosis stage did not change significantly, but six of the 10 patients exhibited an improvement in their fibrosis stage.
  
  
  CONCLUSIONS
  Major clinical parameters and histological observations were significantly improved by the treatment with ezetimibe. Our pilot study demonstrated the efficacy of ezetimibe for drug therapy of NASH and may lead to a large-scale clinical trial in the future.
authors.affiliation: Division of Gastroenterology, Yokohama City University Hospital, 3-9 Fuku-ura, Kanazawa-ku, Yokohama 236-0004, Japan. Email: nakajima-tky@umin.ac.jp.
authors.forename: Masato
authors.initials: M
authors.lastname: Yoneda
authors.forename: Koji
authors.initials: K
authors.lastname: Fujita
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Nozaki
authors.forename: Hiroki
authors.initials: H
authors.lastname: Endo
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Takahashi
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Hosono
authors.forename: Kaori
authors.initials: K
authors.lastname: Suzuki
authors.forename: Hironori
authors.initials: H
authors.lastname: Mawatari
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kirikoshi
authors.forename: Masahiko
authors.initials: M
authors.lastname: Inamori
authors.forename: Satoru
authors.initials: S
authors.lastname: Saito
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Iwasaki
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Terauchi
authors.forename: Kensuke
authors.initials: K
authors.lastname: Kubota
authors.forename: Shiro
authors.initials: S
authors.lastname: Maeyama
authors.forename: Atsushi
authors.initials: A
authors.lastname: Nakajima