Dr Karen Watkins Details the Obstacles Impeding Effective Treatment for Patients With NASH

The lack of FDA approvals for the treatment of nonalcoholic steatohepatitis (NASH) and safety concerns surrounding 2 recommended treatments contribute to the barriers blocking effective progress, said Karen Watkins, PharmD, pharmacist for emerging therapeutics strategy, MedImpact Healthcare Systems.

Transcript

What are some of the barriers to effective treatment for patients with nonalcoholic steatohepatitis (NASH)?

So, the major barrier for treatment right now is there’s actually nothing approved by the FDA for the treatment of NASH, and that will change next year hopefully with the first approval; but currently there are no drug therapies that are approved. So, the guidelines by the American Association for the Study of Liver Diseases do recommend 2 treatments for NASH, but they are used off-label—the first is vitamin E and the second is pioglitazone. The other barriers with those particular agents is that there are some safety concerns with both of those. Vitamin E was associated with a higher rate of mortality in a large meta-analysis. Additionally, in a cancer prevention trial it was shown to have higher rates of prostate cancer, as well as higher rates of hemorrhagic stroke. So, those could be concerns for some patients. With pioglitazone, it does cause increased weight gain, with an average weight gain of 3 to 5 kilograms in patients and this is a major concern for the NASH population since most of them have obesity.