Nonalcoholic fatty liver disease: New drug proves 'safe' and effective
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 tested the benefits of norursodeoxycholic acid (nor-urso) in a placebo-controlled clinical trial.
Previous research has shown that using nor-urso to produce bile acid synthetically helps treat another incurable liver condition, called primary sclerosing cholangitis.
Now, the team conducted a multicenter, double-blind, placebo-controlled, randomized, phase II clinical trial to test the benefits of nor-urso in 198 NAFLD patients in various hospitals and medical centers throughout Austria and Germany.
The scientists randomly divided the participants into:
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.
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.
He goes on: "The bile acid circulates through the body like a steroid hormone and regulates many metabolic processes. In fatty liver disease, it is as if a bile acid signal resistance develops, so that these processes no longer function properly."
Nor-urso, however, "re-intensifies the hormone effect of the bile acid." This improves a patient's outlook and the progression of the disease.
Dr. also explains that "utilizing the signal properties and hormone effects of bile acids" is "in the spirit of personalized medicine" and a crucial step forward in the pursuit of individualized treatments.
In the near future, the researchers plan to test the benefits of nor-urso for cardiovascular disease, as this is the leading cause of death among people with fatty liver disease. Nor-urso could improve cardiometabolic health and life expectancy overall, say the researchers.
"It would be logical to expect that, and we are optimistic. But we have not yet verified it," the Dr. says.
credit goes to medical newstoday
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 tested the benefits of norursodeoxycholic acid (nor-urso) in a placebo-controlled clinical trial.
Studying the benefits of nor-urso for NAFLD
Nor-urso is a modified version of ursodeoxycholic acid, a common oral drug that can alter the makeup of bile and may dissolve gall stones.Previous research has shown that using nor-urso to produce bile acid synthetically helps treat another incurable liver condition, called primary sclerosing cholangitis.
Now, the team conducted a multicenter, double-blind, placebo-controlled, randomized, phase II clinical trial to test the benefits of nor-urso in 198 NAFLD patients in various hospitals and medical centers throughout Austria and Germany.
The scientists randomly divided the participants into:
- a group that received nor-urso capsules for a 500-milligram (mg) daily dosage (67 participants)
- a group that received 1,500 mg of nor-urso daily (67 participants)
- a group that received a placebo (64 participants)
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.
Compound works in a 'personalized' way
The trial's authors explain the mechanisms behind nor-urso's beneficial effects. Study co-author says that synthetically created bile acid protects the liver from inflammation.He goes on: "The bile acid circulates through the body like a steroid hormone and regulates many metabolic processes. In fatty liver disease, it is as if a bile acid signal resistance develops, so that these processes no longer function properly."
Nor-urso, however, "re-intensifies the hormone effect of the bile acid." This improves a patient's outlook and the progression of the disease.
Dr. also explains that "utilizing the signal properties and hormone effects of bile acids" is "in the spirit of personalized medicine" and a crucial step forward in the pursuit of individualized treatments.
In the near future, the researchers plan to test the benefits of nor-urso for cardiovascular disease, as this is the leading cause of death among people with fatty liver disease. Nor-urso could improve cardiometabolic health and life expectancy overall, say the researchers.
"It would be logical to expect that, and we are optimistic. But we have not yet verified it," the Dr. says.
credit goes to medical newstoday
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Labels: builds up in liver, cirrhosis, effective, excessive amount of fat, fibrosis, inflammation, liver cell damage, NAFLD, nonalcoholic steatohepatitis (NASH), nor-urso, oral drug, proves safe
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