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NIH study offers hope to patients with nonalcoholic steatohepatitis
Date:4/28/2010

A daily dose of a specific form of vitamin E significantly improved the liver disease, nonalcoholic steatohepatitis (NASH), according to a study funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health. Results were published April 28 online in the New England Journal of Medicine. In addition, Actos (pioglitazone), a drug used to treat diabetes, also improved many features of NASH but was associated with weight gain.

NASH is a chronic liver disease that is linked to weight gain and obesity and can lead to cirrhosis, or scarring, liver cancer and death. It resembles alcoholic liver disease but occurs in patients who drink little or no alcohol. NASH can occur in children, the elderly, normal-weight, and non-diabetic persons. The disease is believed to be caused by abnormal metabolism of fats, which increases levels of oxidants, compounds that transfer oxygen in the liver. This disease affects about 3 to 4 percent of the U.S. population, leads to death from cirrhosis, and increases the risk of death from cardiovascular disease. There is currently no approved treatment for NASH.

In the Pioglitazone or Vitamin E for NASH Study (PIVENS), investigators from the NASH Clinical Research Network (CRN) compared the two different treatments to placebo. Vitamin E functions as an anti-oxidant while Actos improves the sensitivity of cells to insulin, a hormone that controls sugar and fat metabolism. PIVENS is the largest placebo-controlled, randomized clinical trial of therapies ever conducted for NASH.

"This is an important landmark in the search for effective treatments for NASH," said Pat Robuck, Ph.D., M.P.H., the NASH CRN project scientist and director of the clinical trials program in NIDDK's Division of Digestive Diseases and Nutrition.

The PIVENS trial randomly assigned 247 adults with NASH and without diabetes into three groups. Men and women aged
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Contact: Leslie Curtis
niddkmedia@mail.nih.gov
301-496-3583
NIH/National Institute of Diabetes and Digestive and Kidney Diseases
Source:Eurekalert

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