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Experimental drug improves liver function in NASH patients

Experimental drug improves liver function in NASH patients

A team of American scientists found remarkable results researching an experimental medicine for non-alcoholic steatohepatitis (NASH), which until now cannot be treated medicinally. In their study, they found out that the liver function of NASH patients improved when obeticholic acid was administered. Also, the patients had decreased inflammation, fat in the liver and decreased body weight compared to those who were given a placebo. On the other hand, cholesterol levels increased in the group that received obeticholic acid. Results of this research have been published recently in The Lancet.

NASH is a common liver disorder and is associated with insulin resistance. Due to the growing levels of obesitas, prevalence of NASH is increasing. A NASH patient is often free of complaints, but eventually the disorder leads to steatosis and cirrhosis. This increases the risk of cancer and loss of liver function. Except for life style adjustments, such as maintaining a healthy weight, currently there is no medicinal treatment for NASH.

Searching for a treatment for NASH, the authors started the FLINT trial: a multicentre, double blind, placebo-controlled clinical trial. The study included 283 adult NASH patients who were assigned at random to two groups. One group was administered a daily dose of obeticholic acid, while the other group received a placebo. The researchers intended for the groups to be treated 72 weeks followed by a follow-up period of 24 weeks.

A preliminary analysis of the results showed that obeticholic acid had significant beneficial effects on liver function in NASH patients. The bad news: these patients also showed elevated cholesterol levels. This is a disturbing result, because NASH patients are already at risk for cardiovascular diseases. Based on these two findings, trial investigators decided to stop the trial.

Although their experiment ended prematurely, the scientists support the view that with the FLINT trial, advances are made in the search for a treatment for NASH. “The causes of NASH are not fully understood. Causes and treatments may be different among each patient,” said prof. dr. Brent Neuschwander-Tetri, lead author. “The changes in cholesterol levels need to be studied more to know if they are a risk. 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."

Source: The Lancet

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