According to the European Medicines Agency’s Committee for Medicinal Products for Human Use, current data linking glucagon-like-peptide-1 (GLP-1) agonists to adverse pancreatic events are not adequate….
Their review was based on study findings published in Diabetes that linked GLP-1 therapies with pancreatitis and pancreatic-duct metaplasia in patients with type 2 diabetes. According to the agency press release, the study included a small number of pancreatic tissue samples from donors with and without diabetes who died of non-diabetes causes.
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After consulting a panel of experts, the agency’s Committee for Medicinal Products for Human Use (CHMP) ruled the study as having methodological limitations and potential for bias, including differences in age, gender and disease duration and treatments between the studied groups. The CHMP also reviewed available non-clinical and clinical data and determined no change in evidence regarding the risk for pancreatic adverse events associated with GLP-1 therapies.
The agency acknowledges pancreatitis cases reported in clinical trials and those reported spontaneously, but says they should be interpreted with caution. In addition, they find value in harmonizing product warnings across all GLP-1 based therapies so patients and their healthcare providers receive consistent advice, according to the press release.
“With regard to pancreatic cancer, data from clinical trials do not indicate an increased risk with these medicines,” the press release states. “However, the number of events is too small to draw final conclusions. Due to their mechanism of action some uncertainties remain in respect to the long-term effect of these medicines on the pancreas and more data collection efforts are under way.”
Studies include large outcome trials designed to better understand and quantify risks associated with GLP-1s, in addition to two ongoing independent studies examining the risk profile of diabetes medications, especially in relation to the pancreas.
Results of the first of these studies are expected in 2014.
Similarly in the US, the FDA announced in April that they will investigate findings that suggest an increased risk for pancreatitis and pancreatic duct metaplasia in patients with type 2 diabetes treated with incretin mimetics.
The investigation was prompted by a study conducted by Sonal Singh, MD, MPH,and colleagues at the Johns Hopkins University School of Medicine.