Journal club: Pioglitizone, vitamin E, or placebo for nonalcoholic steatohepatitis

(NEJM, May 2010) In this study, 80 patients received pioglitazone 30 mg/day, vitamin E 800 IU/day or placebo for two years.  Nobody had diabetes mellitus, though insulin resistance was present.  Biopsies were performed before and after.  Major side effect included an average weight gain of 12 lbs. in the pioglitazone group, and the study was not powered to detect any cardiovascular outcomes.

Aminotransferase levels fell in each drug arm, but returned to an elevated level after drug discontinuation.  There were histologic benefits of each study drug, including hepatitis and ballooning degeneration; however, there was NO significant decrease in fibrosis (which was, on average, stage 1.5/4 at the outset).  Quality of life did not change.

Although it is nice to see the reversal of histologic components of NASH, this study does not evidence any important clinical outcomes, like the progression of fibrosis or development of cirrhosis.  After all, in liver disease, that is what really matters.  The study does, however, reconfirm our belief that there are multiple pathways involved in NASH (insulin resistance and free-radical oxidation, for example). 

Due to cardiovascular risk, I would not recommend vitamin E 800 IU, and due to weight gain and potential cardiovascular risk, I would not recommend pioglitazone unless the patient was a diabetic and needed an insulin sensitizer.

For a look at this article, see the link below:

NEJM NASH article, May 2010

Advertisements
This entry was posted in Journal Club. Bookmark the permalink.

Leave a Reply

Please log in using one of these methods to post your comment:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s