The American Diabetes Association (the Association) is calling for all pharmaceutical companies that develop or market incretin-based medications taken by Type 2 diabetics to make patient-level data on their drugs available for an independent review.
In a June 10 press release published on Diabetes.org, the Association acknowledged theories that certain courses of incretin therapy may contribute to the development of pancreatitis or pancreatic cancer in Type 2 diabetics. The Association has proposed this pathological and clinical independent review due to the swirl of unclear information on the risks of taking incretin mimetics.
“The Association is committed to improving the lives of all people with diabetes, ensuring that a broad spectrum of safe and effective therapies are available to meet their personal health needs,” Robert Ratner, Chief Scientific & Medical Officer for the American Diabetes Association, said in a statement on the Association’s website.
Incretin therapy is a common treatment option for Type 2 diabetics. Patients who undergo the therapy take medications such as Glucagon-Like Peptide-1 (GLP-1) receptor agonists and Dipeptidyl-Peptidase-4 (DPP-4) inhibitors meant to improve diabetes control and stimulate weight loss either by themselves or when combined with other drugs, such as insulin. Incretin therapy, according to the article, has come under intense scrutiny as of late due to its potential link to the development of pancreatitis and pancreatic cancer in patients with Type 2 diabetes.
Many, including the FDA, according to a recent drug safety communication, say the time is now to investigate whether incretin mimetic drugs, some of whose manufacturers are already facing lawsuits, pose an increased risk of pancreatitis or pancreatic cancer before more doctors prescribe them to patients without a full understanding of the risks by both parties.
“People who are taking these medications, or who may consider taking them, should have the benefit of all that is currently known about their risks and advantages,” Ratner continued, “in order to make the best possible decisions about their treatment and care in consultation with their health care providers.”
According to a recent case control trial examining autopsy specimens detailed in the article, exposure to sitagliptin, sold and marketed as Januvia, or exenatide, better known as Byetta, in a small number of Type 2 diabetes patients increased cell changes in the pancreas to a greater level than in those without diabetes or those treated with other drugs. These findings, however, have been criticized within the medical community from a methodological standpoint and have yet to be confirmed.