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.

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 participants took the treatment or placebo for a period of 12 weeks. The researchers clinically followed the participants for another 4 weeks after the intervention.
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.

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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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Oral antifungal drug to treat vaginal yeast infection raises risk of miscarriage

Using a common medication to treat vaginal yeast infections during pregnancy could be associated with an increased risk of miscarriage, researchers warned. While topical treatments are used as the first line for pregnant women with fungal infections, oral drug fluconazole is also used during pregnancy. The study,  showed pregnant women who took an oral version of the drug fluconazole were more likely to experience miscarriage than those who did not. 

"Our study shows taking oral fluconazole during pregnancy may be associated with higher chances of miscarriage," said a researcher.

Higher doses of oral fluconazole (over 150 mg) during early pregnancy may also be linked with higher chances of giving birth to a baby with a heart defect, she added. 

The study re-emphasises safe practices during pregnancy, which include correct diagnosis and choosing the safest medication with the largest body of data. For the study, researchers studied data on 441,949 pregnancies. During pregnancy women often get thrush -- a yeast infection caused by the Candida species of fungus, usually Candida albicans -- because of changes going on in the body, especially during the third trimester. 

Thrush during pregnancy can be treated with cream or a tablet inserted in the vagina (a pessary) that contains clotrimazole or a similar antifungal drug. While thrush can also be treated with fluconazole, it should not be taken during pregnancy, or even those trying to get pregnant or breastfeeding, according to the doctors.

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New breast cancer drug may also combat other types of cancer

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The drug, Palbociclib targets the rapid division of tumour cells by inhibiting the activity of the enzymes CDK4 and CDK6.

 

A new oral drug whose efficacy in combating breast cancer has been demonstrated alone and in combination with endocrine therapy also has potential to fight other types of cancer, new research has found.

 Palbociclib targets the rapid division of tumour cells by inhibiting the activity of the enzymes CDK4 and CDK6, which propel cell division and increase in number in most cancers.

It is the first CDK4/6 inhibitor to be approved for the treatment of breast cancer, researchers said.

"All living cells undergo cell division and palbociclib's unique capacity to halt the cell division process (also known as the 'cell cycle') therefore has potentially broad applicability," said the study's lead author Amy S Clark, an assistant professor at the University of Pennsylvania.

"Pairing palbociclib with other anti-cancer therapies such as endocrine therapy, chemotherapy, and targeted therapy can create a powerful combinatorial effect with real promise for addressing a variety of cancers," said Clark.

For example, amplification of CDK4 is reported in a high percentage of melanomas and esophageal cancers.

Targeted therapy uses medication and other interventions to more accurately identify and attack cancer cells, usually while doing no or little damage to normal cells.

"This drug has minor effects on normal cells other than neutrophils (white blood cells)," said the study's senior author, Peter J O'Dwyer, a professor at Penn.

"In tumours, it can cause shrinkage, or more commonly, arrest of growth. As we discover new functions for the CDK4/6 target of this medicine, we are likely to use it in combinations to make other anti-cancer agents work better," said O'Dwyer, also director of the Developmental Therapeutics Programme at the Abramson Cancer Centre (ACC) in US.

In addition to inhibiting the cell cycle, palbociclib has been shown, for example to alter several recently described non-cell cycle functions of CDK4/6, a finding expected to expand its therapeutic role, O'Dwyer added.

Assessing 130 relevant publications in the literature, as well as interpreting their own continuing studies, the team found that in addition to its safety and effectiveness in fighting certain types of breast cancer, early trials of palbociclib have shown promise of effectiveness in cases of lymphoma, sarcoma, and teratoma, tumours that while rare, often afflict younger patients.

A phase 2 trial showed that, among 17 patients with previously treated mantle-cell lymphoma, palbociclib resulted in one complete response and two partial responses.

Although, median progression-free survival was four months, five patients had progression-free survival greater than one year.

Another phase 2 trial with 29 sarcoma patients treated with palbociclib showed a progression-free survival of 66% at 12 weeks, researchers said.

The study was published in the journal JAMA Oncology.