An experimental drug aimed at treating a common liver disease showed promising results and potential problems, in a recent multicenter clinical trial funded by the National Institutes of Health. The FLINT study found that people with nonalcoholic steatohepatitis (NASH) who took obeticholic acid (OCA) had improved liver health during that period. The improvement included decrease in inflammation and fat in the liver, and decreased body weight versus people receiving a placebo. OCA was also found to increase itching and total cholesterol.
The study included 283 people at eight centers across the United States. Participants, who had been diagnosed with definite or borderline NASH, were randomly assigned to one of two groups. One took 25 milligrams of OCA daily and one received a placebo that resembled the OCA pill.
Results of the study found improved liver health in 45 percent of people on OCA versus 21 percent of the placebo group.
In the press release, Dr. Averell Sherker, NIDDK program official for the NASH Clinical Research Network (NASH CRN) said, "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," Sherker said.
The study's lead author, Brent Neuschwander-Tetri, M.D., a professor at St. Louis University said in a press release, "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 is a common, often "silent" liver disease, according to National Digestive Diseases Information Clearinghouse (NDDIC). It resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver, along with inflammation and damage. NASH may have no symptoms and can only be diagnosed with a liver biopsy, and people with the disease are advised to maintain a healthy weight, avoid alcohol and unnecessary medications. NASH is the third leading diagnosis requiring U.S. liver transplantation.
The findings of the study were published in the journal The Lancet.
