PHARMACY

Fatty liver may impose diabetes risk

BY Allison Cerra

NEW YORK — Over the years, a fatty liver has become an indicator of obesity and insulin resistance among humans, but researchers have found that people with fatty livers are five times more likely to develop Type 2 diabetes than their healthier counterparts.

In a new study slated for publication in the Journal of Clinical Endocrinology & Metabolism, researchers examined 11,091 Koreans with fasting insulin concentration, a marker of insulin resistance, and diagnosed the subjects with a fatty liver via an abdominal ultrasound. At baseline, 27% of the population had been diagnosed with having fatty liver.

The researchers followed up after five years of the initial examination and found that regardless of baseline insulin concentration, patients with fatty livers had significantly more metabolic abnormalities, including higher glucose and triglyceride concentration and lower HDL ("good" cholesterol) levels. They concluded that patients with fatty livers were five times more likely to develop Type 2 diabetes.

"We believe that a diagnosis of fatty liver should raise an alarm for impending Type 2 diabetes," said Sun Kim of Stanford University and senior author of the study. "Our study shows that fatty liver, as diagnosed by ultrasound, strongly predicts the development of Type 2 diabetes, regardless of insulin concentration."

"Our study shows in a large population of relatively healthy individuals that identifying fatty liver by ultrasound predicts the development of Type 2 diabetes in five years," Kim added. "In addition, our findings reveal a complex relationship between baseline fatty liver and fasting insulin concentration."

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Protalix receives CRL for Gaucher disease treatment

BY Alaric DeArment

KARMIEL, Israel — The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

The company said the FDA issued a complete response letter for its application for taliglucerase alfa, a treatment for Gaucher disease. The FDA issues a CRL when it has finished reviewing a regulatory application, but questions remain that preclude final approval.

The FDA raised questions about clinical trials, chemistry, manufacturing and controls, Protalix said. The drug maker said that when it submitted the application, the full data were not available, but that it would request a meeting with the FDA to clarify the path to regulatory approval “as soon as possible.”

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Watson seeks regulatory approval for generic Adderall XR

BY Alaric DeArment

PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

Shire said Watson’s latest application is distinct from the one it filed in 2007 that resulted in a settlement between the two companies. Under the Hatch-Waxman Act of 1984, Shire has the right to file a patent infringement lawsuit against Watson in response to the latest application.

Patent protection for the drug expires in April 2019.

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