PHARMACY

Study: Metformin may reduce risk of cancer

BY Allison Cerra

EAST LANSING, Mich. — A drug commonly used to treat Type 2 diabetes may reduce the risk of diabetes-associated cancers, including breast cancer, according to a new study.

The research, led by Michigan State University pediatrics professor James Trosko and colleagues from South Korea’s Seoul National University, believed that cancers originated from human stem cells and that both natural and man-made chemicals enhanced the growth of breast cancer cells in particular. The researchers tested this concept by growing miniature human breast tumors, or mammospheres, which are activated a certain stem cell gene. The team found that estrogen and the chemicals caused the mammospheres to increase in numbers and size; however, the numbers and size of the mammospheres were dramatically reduced when metformin was added.

"People with Type 2 diabetes are known to be at high risk for several diabetes-associated cancers, such as breast, liver and pancreatic cancers," Trosko said. "While metformin has been shown in population studies to reduce the risk of these cancers, there was no evidence of how it worked.

"While future studies are needed to understand the exact mechanism by which metformin works to reduce the growth of breast cancers, this study reveals the need to determine if the drug might be used as a preventive drug and for individuals who have no indication of any existing cancers," he said.

The study was published in the most recent edition of PLoS One.


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Takeda files for approval of alogliptin-metformin combination tablet

BY Alaric DeArment

OSAKA, Japan — A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

The Takeda Global Research and Development Center filed with the Food and Drug Administration for approval of an alogliptin-metformin combination tablet. The company expects the FDA to review the application within the next 10 months.

"This [new drug application] submission further extends Takeda’s commitment to offering patients with Type 2 diabetes a range of therapeutic options to help them manage their condition," Takeda Global Research and Development Center VP clinical science Thomas Strack said. "The worldwide incidence of Type 2 diabetes continues to expand at a rapid rate, and we continue our research into additional medicines to treat these patients."


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FDA approves first drug for insomnia with middle-of-night waking, difficulty returning to sleep

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

The agency announced Wednesday the approval of Intermezzo (zolpidem tartrate) sublingual tablets, made by Port Richmond, Calif.-based Transcept Pharmaceuticals. The drug contains the same active ingredient as Sanofi’s Ambien but at a lower dose. Zolpidem already has lost patent protection, allowing other companies not only to make generic versions of it, but also to develop "branded generics" that are novel formulations of it, as Transcept has done.

"For people whose insomnia causes them to wake in the middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking," FDA Center for Drug Evaluation and Research deputy center director Robert Temple said. "With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving."

 


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