This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Nonalcoholic fatty liver disease (NAFLD) is the most common cause of abnormal liver tests in the United States. NAFLD represents a range of disease from simple fatty deposition in the liver to more aggressive inflammation and fibrosis, termed nonalcoholic steatohepatitis (NASH). Ultimately, NASH may progress to cirrhosis in up to 25% of patients. NASH is histologically similar to alcohol related liver disease. Pro-inflammatory cytokines, notably tumor necrosis factor-alpha (TNF-alpha), play a key role in the development of alcohol related liver disease and are similarly believed to play a role in the development of NASH. The drug pentoxifylline is used for treating peripheral vascular disease, but has also been found to inhibit TNF-alpha production.
The aim of this study is to: 1) examine the efficacy of pentoxifylline as treatment for NASH as assessed by serum markers of liver inflammation 2) assess the effect of pentoxifylline on inflammation and fibrosis by examining histolgoy.Forty-five patients with a diagnosis of NASH will be randomized in a 2:1 (pentoxifylline: placebo) ratio and treated for total of twelve months. Biopsy will be performed at the beginning and end of treatment period. Serum liver chemistries and serum markers of inflammation will be monitored every three months. Histology will be analyzed at beginning and end of treatment for inflammation and fibrosis. Liver tissue will be examined for mRNA expression of gene products related to inflammation and fibrosis.It is anticipated that patients treated with pentoxifylline will have lower ALT levels and improvement in histological evidence of inflammation. It is also anticipated that serum and hepatic TNF-alpha levels will be lower in patients treated with pentoxifylline.
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