Nonalcoholic fatty liver disease: New drug proves ‘safe’ and effective

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A new clinical trial tests the benefits of an oral drug for people with nonalcoholic fatty liver disease and yields very promising results.

In the United States, 30–40% of all adults are living with nonalcoholic fatty liver disease (NAFLD). In Europe, 20–30% of the general population have NAFLD, and the numbers are on the rise.

In NAFLD, which is one of the most common forms of liver disease, an excessive amount of fat builds up in the liver. This fat is not the result of excessive alcohol consumption.

NAFLD can progress into nonalcoholic steatohepatitis (NASH), wherein liver inflammation and liver cell damage accompany the fat buildup. Up to 12% of the U.S. population have NASH, and this condition can progress into cirrhosis and fibrosis.

Currently, the therapeutic options for NAFLD are limited to dietary and lifestyle changes, such as losing weight and exercising more. There are currently no drugs that can treat NAFLD.

However, new research points to a viable pharmacological treatment. Scientists led by Dr. Stefan Traussnigg, from the Department of Medicine III at MedUni Vienna, in Austria, tested the benefits of norursodeoxycholic acid (nor-urso) in a placebo-controlled clinical trial.

The primary outcome that the researchers looked for were levels of alanine aminotransferase (ALT) — an enzyme that resides mainly in the liver. ALT levels are a good measure of liver damage, and assessing them is a standard test for this type of damage.

1,500-mg dosage ‘safe and well-tolerated’

The results of the trial revealed that nor-urso improved liver health, as reflected by ALT levels.

The effects were dose-dependent, so the group that received 1,500 mg of nor-urso daily benefitted the most from the drug, and the reduction of ALT serum levels was the most significant in this group.

A similar number of “serious adverse events” — such as gastrointestinal disorders, abdominal pain, headaches, and infections — occurred in all groups, including that which had taken the placebo.

In conclusion, a 1,500-mg dosage of nor-urso “resulted in a significant reduction of serum ALT within 12 weeks of treatment, when compared with placebo,” write the authors.

“Norursodeoxycholic acid was safe and well-tolerated, encouraging further studies,” they assert.

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