Diabetes Drug May Treat Fatty Liver
Preliminary Study Shows Actos May Ease Nonalcoholic Steatohepatitis (NASH)
Nov. 30, 2006 -- Early research shows the diabetes drug Actos may help treat
nonalcoholic steatohepatitis, a common liver disease that currently has no drug
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
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.
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.
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.
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
- 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.