Diabetes Drug May Treat Fatty Liver

Nov. 30, 2006 -- Early research shows the diabetes drug Actos may help treat nonalcoholic steatohepatitis, a common liver disease that currently has no drug treatment.

However, it's too soon to recommend Actos for nonalcoholic steatohepatitis (NASH) patients, experts warn.

The researchers in this study wanted only to see if Actos was promising enough to deserve a larger, longer study on the possible benefits for NASH patients.

They concluded the drug passed that test.

What Is NASH?

NASH is liver inflammation, possibly with liver damage, caused by a buildup of fat in the liver. The condition can lead to cirrhosis, in which the liver can't function normally.

While it's not normal to have fat in the liver, most people with fatty livers don't have NASH.

The disease affects 2% to 5% of Americans, according to the National Institute on Diabetes and Digestive and Kidney Diseases (NIDDK).

An additional 10% to 20% of Americans have fatty livers, but no liver inflammation or liver damage, says NIDDK.

NASH and other fatty liver conditions are becoming more common, possibly because of the rise in obesity, notes NIDDK.

NASH Study

The new study appears in The New England Journal of Medicine.

Researchers included Renata Belfort, MD, of the University of Texas Health Science Center at San Antonio.

The team studied 55 Texans with NASH. On average, patients were in their late 40s to early 50s and were obese, based on BMI (body mass index), which relates height to weight.

In addition to NASH, the patients also had type 2 diabetes or insulin resistance, a condition which can lead to type 2 diabetes.

Insulin is a hormone that controls blood sugar. In cases of insulin resistance, the body responds sluggishly to the hormone, requiring the body to make more insulin to control blood sugar.

Drug Test

For six months, Belfort's team asked the patients to cut 500 calories from their daily diets and to take either Actos or a sham (placebo) pill daily. The patients didn't know whether they were receiving Actos or the placebo.

Before and after liver biopsies were taken, as well as frequent blood tests to monitor the patients' progress.

The results showed that, during the study, the Actos patients cut their liver fat by 54%; the placebo group had no change in liver fat.

Actos patients also showed a bigger drop in liver inflammation and a greater improvement in insulin response than the placebo group.

Next Step

This study isn't the final verdict on Actos for NASH treatment.

An editorial in the same issue of The New England Journal of Medicine notes that "until the results of large, controlled studies of at least one or two years' duration are available, dietary modification, exercise, and treatment of coexisting conditions should be the preferred strategy for managing [NASH]."

Arthur McCullough, MD, of The Cleveland Clinic and Case Western Reserve University, wrote the editorial.

Until further studies are done, NASH patients may want to follow NIDDK's recommendations:

• Lose extra weight if you're obese or overweight
• Follow a balanced and healthy diet
• Increase physical activity
• Avoid alcohol and unnecessary medications.

Takeda Pharmaceuticals -- which makes Actos -- partially funded the study. Takeda is a WebMD Sponsor.

Also, one of the researchers -- Ralph DeFronzo, MD, of the South Texas Veterans Health Care System in San Antonio -- reports working as a consultant and member of Takeda's advisory board and speakers' bureau.