The Nonalcoholic Steatohepatitis Research Network (NASH CRN) Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis

Nonalcoholic steatohepatitis (NASH) is a common liver disease associated with obesity and diabetes. NASH is a progressive disorder that can lead to cirrhosis and liver failure, and there is no definitive treatment. Insulin resistance and oxidative stress (resulting in lipid peroxidation) are considered to be the two most important mechanisms in the pathogenesis of NASH.<br><br>PIVENS hypothesized that pioglitazone and vitamin E will lead to improvement in hepatic histology in nondiabetic adults with biopsy proven NASH through changes in insulin resistance or oxidative stress. Before and post-treatment liver biopsies were read centrally in a masked fashion for an assessment of steatohepatitis and a NAFLD Activity Score (NAS) consisting of steatosis, lobular inflammation, and hepatocyte ballooning.<br><br>PIVENS enrollment started in January 2005 and ended in January 2007 with 247 patients randomized to receive either pioglitazone (30 mg q.d.), vitamin E (800 IU q.d.), or placebo for 96 weeks. Participants were followed for an additional 24 weeks after stopping the treatment. Both at the initial evaluation and at the completion of treatment 96 weeks later, subjects underwent an assessment of body weight, height, and waist and hip circumferences, and blood samples were obtained for routine biochemical tests and assessment of fasting levels of lipids, glucose, and insulin. Body composition was assessed with the use of dual-energy x-ray absorptiometry. The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) was administered for the assessment of quality of life.

The complete PIVENS data is now available.