WEDNESDAY, Nov. 29 (HealthDay News) -- The diabetes drug Actos may help prevent serious complications from a liver disease that may affect up to 20 percent of Americans.
In a study published in the Nov. 30 issue of the New England Journal of Medicine, University of Texas researchers report that pioglitazone -- brand name Actos -- reduced liver fat by 54 percent in people who had nonalcoholic steatohepatitis (NASH), a complication of fatty liver disease that can lead to liver failure.
"We're excited because we now have a pharmacological option that might help prevent end-stage liver disease," said one of the study's authors, Dr. Kenneth Cusi, an associate professor of medicine at the University of Texas Health Science Center in San Antonio.
While few people have ever even heard of nonalcoholic fatty liver disease, the disorder may affect as many as 20 percent of Americans, according to the American Liver Foundation. Additionally, the liver foundation estimates that about 5 percent of Americans have NASH. Cusi said nonalcoholic fatty liver disease probably accounts for about half of the people who develop cirrhosis of the liver.
The liver normally contains some fat, but in fatty liver disease, excess fat deposits in the liver and may account for more than 5 percent to 10 percent of the organ's weight. The disorder is primarily caused by being overweight. Insulin resistance, diabetes and high levels of cholesterol all contribute to the development of nonalcoholic fatty liver disease and its complications.
The disorder rarely causes symptoms, is difficult to diagnose, and there are no medications approved for the treatment of fatty liver disease. Current treatment is aimed at lifestyle changes, such as losing weight and exercising regularly.
Cusi said the researchers chose to study pioglitazone because it seemed to be a "perfect fit," since it can improve the metabolism of blood glucose, and it decreases cholesterol.
The new study included 55 people with nonalcoholic steatohepatitis and either insulin resistance or type 2 diabetes. About half of the group was given 45 milligrams of pioglitazone daily for six months, while the other half received a placebo. Both groups were asked to maintain a lower calorie diet.
Takeda Pharmaceuticals, the manufacturer of Actos, provided the medications and some of the funding for the study.
The group taking pioglitazone saw a decrease in their levels of abnormal liver enzymes and a significant -- 54 percent -- reduction in liver fat, compared to the placebo group. Insulin sensitivity in the liver improved by 48 percent in the pioglitazone group, compared to 14 percent in the placebo group.
The amount of liver inflammation was also significantly reduced in the treatment group but not the placebo group. Cusi said there was also a greater reduction in fibrosis, which is the damaging scarring that occurs in the liver as a result of NASH, for the pioglitazone group, compared to those on a placebo. However, while this finding was important, Cusi said this difference was not statistically significant.
Cusi added that while these findings are exciting, larger studies of longer duration need to be done to confirm pioglitazone's effectiveness.
He noted that very few side effects occurred in the treatment group. Weight gain, which is a known side effect of this medication, is a concern, but Cusi said he believes the benefits of this drug outweigh the potential risks of increased weight. And, he said, if people are following the recommended lower-calorie diet, weight gain shouldn't be significant.
Dr. Roshini Rajapaksa, a gastroenterologist at New York University Medical Center in New York City, said, "I thought this was a good study, but it's still a small number of patients, and the follow-up was short. But, this is a disease we don't have any proven effective treatments for, so anything that looks promising is something to be excited about."
She added that "both doctors and patients need to be more aware of this condition, and doctors need to get better at diagnosing it, especially as new treatments become available."