Following an in-depth investigation into the safety of glucagon-like-peptide-1 (GLP-1) based therapies in people with diabetes, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that current evidence does not suggest an association between these therapies and an increased risk of adverse pancreatic events.
The review was carried out in response to the publication of a study, which suggested an increased risk of pancreatitis and pancreatic-duct metaplasia in people receiving GLP-1 based therapies for type 2 diabetes. In this study, a group of independent academic researchers examined a small number of pancreatic tissue samples received from organ donors both with and without diabetes, who had died due to other causes.
After a thorough analysis of the publication, a CHMP panel of experts concluded that the study had numerous sources of potential bias and considerable methodological constraints which limit the interpretation of its results. Most importantly, the CHMP reported a great degree of heterogeneity in the characteristics between each study group, including differences in age, gender, diabetes duration and diabetes therapies. All other available non-clinical and clinical data were also considered by the CHMP, who found no evidence supporting an increased risk of adverse pancreatic events associated with GLP-1 based therapies.
Although clinical trial data and other spontaneous reports have observed cases of pancreatitis with GLP-1 based therapies, it is essential that these cases are interpreted with caution. Data from clinical trials was not found to reflect an increased risk of pancreatic cancer with these treatments, although the low number of events makes it difficult to draw a final conclusion. As GLP-1 based therapies work by stimulating beta-cell function and suppressing alpha cell-function, more research into the long-term effects of these medicines is currently being carried out.
Outcomes associated with GLP-1 based therapies are being closely monitored by the marketing authorisation holders of these medicines, who frequently report their findings to the European Medicines Agency (EMA). Multiple studies are presently being planned or carried out, which aim to improve our understanding of the risks associated with these treatments, particularly with regard to pancreatitis and pancreatic cancer. Risk management plans will be updated by marketing authorisation holders accordingly.
Results from two large studies evaluating the risks of diabetes treatments are expected in early 2014. The EMA will continue to analyse all information regarding the use of these medicines to ensure the benefit-risk balance is optimally maintained for people receiving GLP-1 based diabetes therapies.
