Study Shows Diabetes Drugs May Cause Pancreatic Damage

A recent study found that people who take certain diabetes drugs known as incretic mimetic drugs may experience pre-cancerous pancreatic cell growth and damage. Incretic mimetic drugs include Januvia, Victoza and Byetta.

The study, led by Alexandra Butler and Peter Butler of the University of California, Los Angeles, suggests evidence of a link between increased pre-cancerous changes in diabetic patients that use incretin mimetics, as reported by Public Citizen, a Washington-based public advocacy group, after the research was published.

Earlier this month, the U.S Food and Drug Administration (FDA) said it was reviewing unpublished findings by a group of academic researchers suggesting pre-cancerous cellular changes may be associated with Type 2 diabetes treatments, known as incretin mimetics, which also include Bristol-Myers Squibb Co.’s Byetta and Novo Nordisk A/S’s Victoza.

Doctors had been concerned that this category of diabetes treatments may damage the pancreas since the FDA reported receiving a high number of cases of pancreatitis in patients taking Byetta in 2007. The agency issued a similar alert for Januvia in 2009.

An analysis of insurance records published last month in the journal JAMA Internal Medicine showed such drugs may double a user’s risk of pancreatitis. That hasn’t stopped these medicines from becoming multi-million dollar drugs.

The American Diabetes Association said that an examination of the pancreases of 20 diabetic patients showed a 40 percent increase in pancreatic cells, as well as cell damage in patients treated with incretin therapy, according to study results.

Of the 20 pancreases examined, eight were from people taking incretin therapy, while 12 were on other treatment, according to a study published March 22 in Diabetes, a journal of the American Diabetes Association. Seven of the eight patients taking incretin therapies for more than a year were using Merck’s Januvia, while the other was using Byetta, according to the study. These and similar drugs are currently under investigation by the FDA for their possible links to pancreatitis and pancreatic cancer.

The results of the study showed that incretin therapy in humans resulted in “marked” cell proliferation and damage that could potentially develop into cancer, according to Bloomberg News.

Although studies have shown conflicting reports on the effects of the incretin class of drugs in the pancreas of animals, this is the first study to reveal such changes in the pancreas of humans. The research was made possible by a unique research consortium (Network for Pancreatic Organ Donors with Diabetes) led by Dr. Mark Atkinson at University of Florida. The network, funded by the Juvenile Pediatric Research Foundation, obtains pancreases from deceased organ donors, with permission of their next of kin, to study tissues of diabetics to help better understand the disease.

It has been reported that the pancreases of individuals who had received incretin therapy were larger than those of patients treated with other types of diabetes therapies. This is associated with increased cellular proliferation. Incretin-treated patients showed an increase in pancreas dysplasia, an abnormal form of cell proliferation that is a risk factor for pancreatic cancer, as well as an expansion of alpha cells, endocrine cells that make the hormone glucagon.

Merck, disagrees with the study’s hypothesis, is confident in the safety of its drug and hasn’t seen any causal link between it and pancreatitis or pancreatic cancer, Kelley Dougherty, a spokeswoman for the Whitehouse Station, New Jersey-based drug maker, said in a statement.

Byetta, also known as exenatide, “an extensive nonclinical safety program was conducted to support the marketing applications of exenatide twice daily and exenatide once weekly,” Ken Dominiski, spokesman for Bristol-Myers, said in an email. “In those studies, exenatide administration was not associated with any drug-related pancreatic tissue damage or toxicity in any species tested.”

Victoza, also known as liraglutide, is the fastest-growing product for Bagsvaerd, Denmark-based Novo, with sales jumping 58 percent in 2012 to $1.7 billion. The medicine mimics a hormone called GLP-1 to stimulate natural insulin production.

A Novo spokeswoman declined to comment on the study published.

Dr. Sonal Singh of Johns Hopkins University School of Medicine and Public Health, led a recent study published in JAMA Internal Medicine suggesting a doubling in the risk of hospitalization for acute pancreatitis with the GLP-1 based therapies and also recommended further research.

“Since most risk factors for acute pancreatitis are also linked to an increased risk of pancreatic cancer, these findings in the human pancreas are very concerning,” said Singh, an assistant professor of medicine and international health. “Now that GLP-1-based therapies have been shown to increase the risk of pancreatic inflammation and abnormal cell proliferation, further studies are needed to urgently clarify whether these linkages lead to pancreatic cancer with long-term use.”

Diabetes is a chronic, serious disease that affects millions of Americans yearly. Most diabetics require daily medication to keep their condition stable, however, the new study may chance their minds. Would you continue use of your diabetes medication if the chance of pancreatitis or pancreatic cancer exists?

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