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

18 years and older were randomized to either receive 30 milligrams of Actos daily, 800 international units of a form of vitamin E (RRR-alpha-tocopherol) daily, or placebo for 96 weeks. Researchers reported that vitamin E and Actos helped certain patients with NASH.

After 96 weeks of treatment, vitamin E improved all features of NASH except the degree of cirrhosis in the liver. Forty-three percent of participants treated with vitamin E met the primary endpoint of the trial compared to only 19 percent of those who received a placebo. The primary endpoint was a composite of the scores for several features of NASH--retention of lipids, liver inflammation, and liver degeneration. The scores were used to assess disease activity.

While Actos improved liver inflammation and retention of lipids in 34 percent of individuals who received it, suggesting a benefit, the improvement fell short of being statistically significant. Actos also led to an undesirable weight gain of 10 pounds over the 96-week trial. There was an early improvement in liver enzyme tests among participants receiving either Actos or vitamin E. However, upon stopping the medications, the liver enzymes worsened again suggesting the need for long-term treatment.

While the PIVENS trial provides evidence that vitamin E benefits NASH patients, it is not a panacea, said Arun Sanyal, M.D., NASH CRN co-chair and PIVENS principal investigator and chair of gastroenterology at Virginia Commonwealth University in Richmond.

"This study was conducted in people who had NASH but did not have diabetes. The benefits of either treatment in NASH patients who have diabetes remain unknown," said Sanyal. "Also, the study lasted only two years and the potential long-term benefits and risks of taking vitamin E or Actos in these doses are still uncertain."

Researchers acknowledge that many participants receiving these treatments did not improve. To better understand response t
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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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