Efficacy of ezetimibe for the treatment of non-alcoholic steatohepatitis: An open-label, pilot study.
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.
Yoneda
Masato
M
Division of Gastroenterology, Yokohama City University Hospital, 3-9 Fuku-ura, Kanazawa-ku, Yokohama 236-0004, Japan. Email: nakajima-tky@umin.ac.jp.
Fujita
Koji
K
Nozaki
Yuichi
Y
Endo
Hiroki
H
Takahashi
Hirokazu
H
Hosono
Kunihiro
K
Suzuki
Kaori
K
Mawatari
Hironori
H
Kirikoshi
Hiroyuki
H
Inamori
Masahiko
M
Saito
Satoru
S
Iwasaki
Tomoyuki
T
Terauchi
Yasuo
Y
Kubota
Kensuke
K
Maeyama
Shiro
S
Nakajima
Atsushi
A