The Committee of the Primary Care Diabetes Society (PCDS) is aware that healthcare professionals and people with type 2 diabetes may have concerns regarding recent publications and media announcements regarding a possible association between incretin-based therapies (dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists) and pancreatic disease.
These include findings from a group of independent academic researchers suggesting an increased risk of pancreatitis (inflammation of the pancreas) and precancerous cellular changes called pancreatic-duct metaplasia in patients with type 2 diabetes treated with incretin-based therapies (Butler et al, 2013). The study involved examination of a small number of pancreatic tissue samples obtained from organ donors with and without diabetes, who died due to causes other than diabetes.
The PCDS Committee questions whether the recent reports add anything further to our current knowledge of these therapeutic agents, which remain an important and very useful addition to our diabetes formularies.
After reviewing the emerging evidence, the PCDS Committee currently advises that healthcare professionals make no changes to their current practice in relation to these agents. The European Medicines Agency (EMA, 2013), the US Food and Drug Administration (FDA, 2013) and the Medicines and Healthcare products Regulatory Agency (2013) have made similar recommendations. The PCDS Committee has reached this conclusion on the basis of the following factors.
The potential link between these therapies and pancreatitis has been known for several years, and is reflected in the current prescribing information.
- European and American regulatory authorities are currently reviewing the evidence (EMA, 2013; FDA, 2013). Specifically, the EMA is currently investigating the information provided by the researchers to determine the need for any change to the way these products are used.
- Current EMA advice is that these drugs remain available treatments to NHS patients and there is no need for people with diabetes to stop taking their medicines.
- The SAFEGUARD study (http://clinicaltrials.gov/ct2/show/NCT01744236) is currently underway to further investigate this issue.
Furthermore, the Committee makes the following additional recommendations to healthcare professionals when prescribing these agents.
- All patients should be adequately screened regarding their potential risk of pancreatitis (hypertriglyceridaemia, alcohol intake, presence of gallstones, past medical history of pancreatitis).
- All patients should be advised about pancreatitis and informed of how to recognise early symptoms and to seek medical advice should these occur.
The Committee will continue to monitor the available and emerging evidence and issue further statements if its opinion changes.
Butler AE, Campbell-Thompson M, Gurlo T et al (2013) Marked expansion of exocrine and endocrine pancreas with incretin therapy in humans with increased exocrine pancreas dysplasia and the potential for glucagon-producing neuroendocrine tumors. Diabetes 62(7): 2595–62
European Medicines Agency (2013) European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type-2 diabetes. Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/03/
news_detail_001753.jsp&mid=WC0b01ac058004d5c1 (accessed 11.06.2013)
Medicines and Healthcare products Regulatory Agency (2013) Statement on GLP-1 medicines used to treat diabetes. Available at: www.mhra.gov.uk/NewsCentre/CON288084 (accessed 11.06.2013)
US Food and Drug Administration (2013) FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes. Available at: www.fda.gov/Drugs/DrugSafety/ucm343187.htm (accessed 11.06.2013)