By John Gever, Senior Editor, MedPage Today
November 06, 2009

BOSTON -- Vitamin E and, potentially, pioglitazone (Actos) may become the first effective treatments for nonalcoholic steatohepatitis (NASH), a researcher said here.

About 43% of NASH patients in a randomized, placebo-controlled trial met the study's primary endpoint -- a composite of improved liver function, decreased ballooning, and stabilization of fibrosis -- after about two years of vitamin E treatment, compared with less than 20% of patients on placebo (P<0.001), according to Arun Sanyal, MD, of Virginia Commonwealth University in Richmond.

The data showed that, for most of the individual measures of NASH disease activity, pioglitazone was approximately as effective as vitamin E, Sanyal said, with both agents superior to placebo.

Still, he said, the key finding was that vitamin E was clearly an effective treatment for active NASH.

Patients were randomized to receive placebo, 30 mg/day of pioglitazone, or 800 IU/day of vitamin E, in the form of rrr a-tocopherol for 96 weeks, at which point a liver biopsy was obtained. Other outcomes were measured at week 120.

Just over half of both the vitamin E and pioglitazone groups showed resolution of NASH, Sanyal said, compared with about 25% of the placebo group (P<0.01 for both active-treatment groups versus placebo).

About 55% of vitamin E patients showed improvement in steatosis, as did some 70% of those taking pioglitazone. In the placebo group, 30% improved.

Scott Friedman, MD, president of AASLD and a hepatologist at Mount Sinai School of Medicine in New York City, said the study was among the most important reported at this year's meeting.

"This should resurrect our efforts to use antioxidants for NASH," he said.

However, he cautioned that over-the-counter vitamin E supplements may not have the same effect seen in the trial. He noted that quality of commercial supplements is largely unregulated and may vary from one product to another.

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