A double-blind randomized placebo-controlled trial of orlistat for the treatment of nonalcoholic fatty liver disease

Clin Gastroenterol Hepatol. 2006 May;4(5):639-44. Epub 2006 Apr 17.

A double-blind randomized placebo-controlled trial of orlistat for the treatment of nonalcoholic fatty liver disease.

Zelber-Sagi S, Kessler A, Brazowsky E, Webb M, Lurie Y, Santo M, Leshno M, Blendis L, Halpern Z, Oren R.

 

Abstract

BACKGROUND & AIMS:

Few controlled studies have addressed the issue of effective medical treatment for nonalcoholic fatty liver disease (NAFLD). We herein assessed the effect of orlistat in patients with NAFLD.

 

METHODS:

We performed a randomized, double-blind, placebo-controlled study on 52 patients with NAFLD diagnosed by ultrasound (US) and confirmed by liver biopsy (40 patients). The patients were randomized to receive either orlistat (120 mg 3 times daily for 6 months) or placebo. All patients participated in an identical behavioral weight loss program. All patients underwent monthly evaluation by abdominal US; liver enzyme levels, lipid profiles, insulin levels, and anthropometric parameters were monitored, and all patients underwent nutritional follow-up evaluation. Twenty-two patients underwent a second liver biopsy examination at the end of the study.

 

RESULTS:

 

Fifty-two patients were recruited and 44 (mean age, 47.7 y; mean body mass index, 33) completed the study. Serum glucose and insulin levels (P<.03) were significantly higher in the orlistat group, which also presented a higher degree of fibrosis. Body mass index was reduced significantly in each group, with a nonsignificant difference between the groups. Serum alanine transaminase (ALT) levels decreased significantly in both groups, with an almost 2-fold reduction in the orlistat group (48% vs 26.4%). There was a statistically significant reversal of fatty liver by US only in the orlistat group (P<.05).

 

CONCLUSIONS:

Orlistat improves serum ALT levels and steatosis on US in NAFLD patients, beyond its effect on weight reduction.

 

Reference: http://www.ncbi.nlm.nih.gov/pubmed/16630771

 


 

 

 

 

 

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دفتر مرکزی :  تهران ، کیلومتر 18 جاده مخصوص کرج - خیابان داروپخش - درب شماره 2 - شرکت داروسازی اکسیر 

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