People suffering with the ‘silent’ liver disease known as nonalcoholic steatohepatitis, or NASH, may be encouraged with the results of a recent study. A new clinical trial funded by the National Institutes of Health found liver health was improved in people who took obeticholic acid, an experimental drug developed by Intercept Pharmaceuticals, Inc., a biopharmaceutical company.
Obeticholic acid is a first-in-class lead product candidate that regulates kidney, liver, and intestinal functions, according to Intercept. This new drug is promising for people with liver disease.
The multicenter clinical trial called Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment Trial, or FLINT, was published in The Lancet on November 6.
Obeticholic acid is promising for liver disease patients because it decreases fat and inflammation in the liver. In addition, it helps people lose some of their excess body weight.
Dr. Averell Sherker, MD., the National Institute of Diabetes and Digestive and Kidney Diseases program official for the NASH Clinical Research Network, had this to say about liver disease and the FLINT study they performed.
“NASH is a common and potentially serious disease that currently has no approved treatment. Management typically includes weight loss through diet and exercise. Although obeticholic acid did not eliminate liver disease in FLINT participants, it demonstrated a promising effect. Larger studies will be required to determine the drug’s safety and efficacy.”
According to the results of the study, liver health improved in 45 percent of the liver disease patients who took obeticholic acid, versus 21 percent who took a placebo.
The FLINT researchers enrolled 283 study participants, 18 years and older, in eight centers across the United States. Participants consisted of liver disease patients with borderline or definite NASH.
The study participants were randomly assigned to two groups. One group received a placebo that looked like an obeticholic acid pill, and the other group received 25 milligrams of obeticholic acid each day. This study was a double-blind study; both the investigators and participants had no idea which group they were assigned.
Though obeticholic acid showed promising signs and was significantly beneficial for people with NASH liver disease, there were some unanticipated increases in cholesterol for patients who took the drug. It turns out that HDL cholesterol, or ‘good’ cholesterol, decreased and LDL cholesterol, or ‘bad’ cholesterol, increased in subjects who took the obeticholic acid pill daily.
More research is required to recognize the possible effects of obeticholic acid on cholesterol and liver disease.
The study’s lead author, Brent Neuschwander-Tetri, M.D., a professor at St. Louis University, had the following to say about the trial.
“The FLINT trial represents an important advance in the search for treatments of NASH. The causes of NASH are not fully understood, and causes and treatments may be different among patients. We need to study the changes in cholesterol levels more to know if the increases caused by obeticholic acid increase the risk of hardening of the arteries. We found that the improvement in liver enzymes with obeticholic acid were not sustained after treatment was stopped, so we would expect that treatment would need to be indefinite, much like the medications for diabetes and hypertension.”
NASH can only be diagnosed with a liver biopsy. It resembles alcoholic liver disease, however, people who drink very little alcohol or no alcohol at all may get this ‘silent’ disease. The main features of NASH consist of fat in the liver, including damage and inflammation.
Most people with this liver disease may feel well and not even know they have the illness. It is critical that people who have NASH maintain a healthy weight and avoid unnecessary medication and alcohol.
NASH is the third leading cause of liver transplants. As the obesity epidemic continues to rise, NASH liver disease cases are expected to increase, as well.
[Photo courtesy of Wikipedia]