A combination of pioglitazone and vitamin E can lead to better liver histology in adults with type 2 diabetes, but treatment with vitamin E alone does not provide substantial benefits, suggesting that the vitamin does not play as large a role in the combination therapy, according to findings published in Diabetes Care.
“We were disappointed that vitamin E did not work because the only other therapeutic approach that the liver guidelines had implied to be used was vitamin E in patients without diabetes,” Kenneth Cusi, MD, FACP, FACE, professor of medicine and chief of the division of endocrinology, diabetes and metabolism at the University of Florida and Endocrine Today Editorial Board member, said in an interview. “These are the two only options that are recommended, and they are cheap. Pioglitazone can cost $5 to $10 and vitamin E costs pennies. We thought this would be something that would be good for a large number of patients. … We were disappointed, but it’s information that is important for the management of these patients.”
Using a double-blind, randomized controlled trial design, Cusi and colleagues recruited 105 adults with type 2 diabetes and nonalcoholic steatohepatitis (NASH) from two clinics in Florida and Texas. Participants were randomly assigned to treatment plans for 18 months. These plans included 400 IU vitamin E twice daily (n = 36; mean age, 60 years; 8.3% women), 400 IU vitamin E twice daily plus 45 mg per day pioglitazone (n = 37; mean age, 60 years; 18.9% women) or a placebo regimen (n = 32; mean age, 57 years; 6.3% women), according to the researchers.
A combination of pioglitazone and vitamin E can lead to better liver histology in adults with type 2 diabetes, but treatment with vitamin E alone does not provide substantial benefits.
The researchers found that nonalcoholic fatty liver disease scores decreased by at least 2 points in a higher proportion of participants in the combination therapy group compared with the placebo group (54% vs. 19%; P = .003). They noted that more participants taking vitamin E alone achieved this outcome compared with placebo, but not to a significant degree. Similarly, more participants achieved resolution of their NASH when they took combination therapy compared with placebo (43% vs. 12%; P = .005) and when they took vitamin E alone, but without statistical significance for the latter regimen. Those on a combination regimen had better results in steatosis (P < .001), inflammation (P = .018) and ballooning (P = .022) compared with placebo, the researchers reported.
“Consider working with your local hepatologist to consider referral and further evaluation, and consider some new imaging techniques that can help identify fibrosis,” Cusi said. “Most importantly, know that a 7% to 10% weight loss by lifestyle intervention improves NASH and fibrosis and that pioglitazone is a viable option for these patients.” – by Phil Neuffer
For more information:
Kenneth Cusi, MD, FACP, FACE, can be reached at University of Florida College of Medicine, 1600 SW Archer Road, Room H-2, Gainesville, FL 32610; email: Kenneth.Cusi@medicine.ufl.edu.
Disclosures: The authors report no relevant financial disclosures.