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Type 2 diabetes

GLP-1 drugs associated with increased risk of pancreatitis

Diabetics twice as likely to be hospitalised
AACE and ADA claim study does not provide the basis for diabetics to change treatment
Acute pancreatitis

Patients with type 2 diabetes who take glucagon-like peptide-1-based therapies (GLP-1) are associated with an increased risk of hospitalisation from acute pancreatitis, according to researchers from Johns Hopkins University School of Medicine.

The GLP-1 mimetic drugs, which include GLP-1 agonists such as exenatide and DPP-4 inhibitors such as sitagliptin, are the most recently launched drug classes for the treatment of type 2 diabetes. According to the study, the agents exenatide and sitagliptin (sold under the brand names Byetta and Januvia, by Amylin Pharmaceuticals and Merck) appear to contribute to the formation of lesions in the pancreas and the proliferation of ducts in the organ, resulting in wellsprings of inflammation.

"These agents are used by millions of Americans with diabetes,” says study leader Dr Sonal Singh, assistant professor, Division of General Internal Medicine, Johns Hopkins. “These new diabetes drugs are very effective in lowering blood glucose. However, important safety findings may not have been fully explored and some side effects such as acute pancreatitis don't appear until widespread use after approval.”

Although physicians and regulators have been aware that pancreatitis could be a side effect of GLP-1 therapies, this study published in the journal JAMA Internal Medicine, is the first to accurately measure the strength of this risk in analyses that accounted for other pancreatitis risk factors, such as gallstones, obesity and heavy alcohol use.

Singh and his colleagues based their findings on analysis of data from seven BlueCross BlueShield health insurance plans. They identified 1,269 beneficiaries with type 2 diabetes who had at least one prescription for any drug to treat the disease between 2005 and 2008. After matching them with 1,269 type 2 diabetics who had not, and controlling for the other known pancreatitis risk factors, the researchers found that people who took one of the GLP-1 therapies were twice as likely to be hospitalised with pancreatitis within 60 days of first taking the drugs as those who had taken a different medication.

Speaking to Medscape News, Singh said that although the outcomes indicate a possible link between the agents and pancreatitis this does not mean that people should stop using these drugs.

Drs Belinda Gier and Peter Butler, University of California, Los Angeles, wrote in an accompanying commentary: "At present, the GLP-1 class of drugs is heavily promoted and prescribed as having purported advantages that outweigh its risks. Singh and colleagues provide a timely reminder that, despite large numbers of underpowered studies claiming the contrary from marketing companies, little is yet known about long-term adverse effects of the GLP-1 class of drugs on the exocrine pancreas.”

Joint statement

In a joint statement the American Association of Clinical Endocrinologists and the American Diabetes Association claim the study “does not provide the basis for changing treatment in people with diabetes.”

They state that the retrospective study uses data from an administrative database, and that this type of analysis is not considered as robust as a prospective randomised controlled clinical trial.

The statement continues, “There are currently nine on-going, prospective, controlled trials of GLP-1 based therapy with over 65,000 subjects, which should provide answers to these important safety questions.”

Although they acknowledge that there are risks and benefits associated with any therapy, this retrospective analysis indicates GLP-1 based therapies are associated with a relatively small excess risk of hospitalisation for acute pancreatitis, with only two additional cases per 100 patients over a three-year period. They claim that the same population of adults (between the ages of 18-64 with type 2 diabetes) has a greater risk of hospitalisation for acute pancreatitis if they used tobacco, consumed alcohol or were obese.

The research was supported by the Johns Hopkins Clinical Research Scholars Program, the National Institutes of Health's National Center for Research Resources and the NIH Roadmap for Medical Research.

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