American Diabetes Association Calls for Independent Review of Incretin Therapy
June 10, 2013
The American Diabetes Association (the Association) is asking all pharmaceutical companies involved in the development or marketing of incretin-based medications, used to lower blood glucose levels, to make patient-level data on their products available for an independent review that could help settle the question of whether such therapies contribute to the development of pancreatitis or pancreatic cancer.
Incretin therapy refers to medications such as GLP-1 receptor agonists and DPP-4 inhibitors, which are used to improve diabetes control and increase weight loss, either alone or in conjunction with other medications such as metformin or insulin. Recent publications have intensified the controversy surrounding the potential role of incretin therapy in the development of pancreatitis and pancreatic neoplasia in people with type 2 diabetes.
“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,” said Robert Ratner, MD, FACP, FACE, Chief Scientific & Medical Officer, American Diabetes Association. “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 in order to make the best possible decisions about their treatment and care in consultation with their health care providers.”
A great deal of controversy has recently arisen around the role of incretins as a possible cause of pancreatitis and pancreatic neoplasia. Administrative database analyses suggest either no effect on pancreatitis or a small risk associated with incretin therapy, but it is less than that due to obesity or alcohol ingestion. A recent case control trial examining autopsy specimens suggested that exposure to sitagliptin or exenatide in a small number of subjects increased neoplastic changes in the pancreas of subjects with type 2 diabetes to a greater extent than that seen in nondiabetes subjects or diabetic patients treated with drugs other than incretins. This analysis has been criticized from a methodologic standpoint and remains unconfirmed.
To provide clarity for patients and health care providers in this controversial area, the Association is proposing that an independent review of available clinical and pathologic data be conducted. Toward this end, the Association is calling on all pharmaceutical companies with incretin therapies in development or currently marketed to make patient-level data available on all subjects involved in regulatory trials for an independent analysis. The Association proposes to release a call for applications from academic and research organizations capable of integrating large experimental databases to illuminate the potential role of incretin therapy in pancreatic pathology.
About the American Diabetes Association
Nearly half of American adults have diabetes or prediabetes; more than 30 million adults and children have diabetes; and every 21 seconds, another individual is diagnosed with diabetes in the U.S. Founded in 1940, the American Diabetes Association (ADA) is the nation’s leading voluntary health organization whose mission is to prevent and cure diabetes, and to improve the lives of all people affected by diabetes. The ADA drives discovery by funding research to treat, manage and prevent all types of diabetes, as well as to search for cures; raises voice to the urgency of the diabetes epidemic; and works to safeguard policies and programs that protect people with diabetes. In addition, the ADA supports people living with diabetes, those at risk of developing diabetes, and the health care professionals who serve them through information and programs that can improve health outcomes and quality of life. For more information, please call the ADA at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn)