There have been numerous studies on the safety and efficacy of using vitamin E to treat nondiabetic patients with nonalcoholic steatohepatitis (NASH), but researchers at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) presented results of vitamin E in diabetic and nondiabetic patients.
According to the study's principal investigator Kris Kowdley, MD, FAASLD, Director of the Liver Care Network and Organ Care Research at Swedish Medical Center, in Seattle, Washington, USA this is the first time data on diabetic patients with NASH is being presented, and the results show that vitamin E shows the same efficacy in patients with diabetes as in those without diabetes.
NASH is a metabolic disorder that resembles alcoholic liver disease but occurs in patients who drink little or no alcohol and can occur in children to the elderly, as well as people with and without diabetes. Vitamin E has been studied as a treatment for NASH in the PIVENS trial which included subjects without diabetes. The investigators previously showed that vitamin E showed histologic improvement non-diabetic patients with NASH.
The FLINT trial of obeticholic acid versus placebo allowed patients with diabetes to be enrolled; the trial was stopped early because it met its primary endpoint and demonstrated significant histologic improvement with obeticholic acid. Concomitant vitamin E use was permitted in study subjects in the FLINT study.
In the study presented at this meeting, researchers looked at histologic improvement and NASH resolution among the PIVENS and placebo-treated FLINT patients with and without diabetes taking vitamin E. They also looked at the incidence of cardiac events and changes in serum lipid levels. Data were examined from 250 total patients randomized to vitamin E (80 subjects) in PIVENS, placebo in PIVENS (72 subjects) and FLINT patients being treated with placebo (98 subjects) including patients taking and not taking vitamin E.
The results of the pooled analysis from these studies demonstrate that safety and efficacy of vitamin E is the same for patients with NASH and diabetes as for those with NASH and without diabetes. As many patients with NASH also have diabetes, the authors of their findings support clinical trials in diabetic NASH.
"This study provides evidence supporting further study of vitamin E in both diabetic and non-diabetic patients with NASH; vitamin E use was not associated with increased cardiac complications or altered serum lipid levels in diabetic patients," said Dr. Kowdley.
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