ABCD position statement on GLP-1 based therapies and pancreatic damage

Abstract

• A recent 'joint investigation by the BMJ and Channel 4's Dispatches current affairs programme' has brought widespread attention to the possibility that GLP-1 based therapies may cause pancreatic damage • A plausible mechanism has been proposed by which GLP-1 based therapies might lead to pancreatitis and even pancreatic cancer. The animal data behind this mechanism are inconsistent and the human histological data are preliminary and open to alternative explanations. Nevertheless, a cautious approach would seem reasonable • The single observational study in support of the hypothesis that GLP-1 based therapies cause pancreatitis is open to criticism and is not supported by other such observational studies • Results from studies involving adverse events reporting systems cannot be relied upon because of 'notoriety bias' • In the ABCD nationwide audits of GLP-1 receptor agonists (GLP-1RAs) in real clinical use in the UK, use of these agents was associated with improvements in glycaemic control and weight and reduction in other diabetes therapies, in particular insulin. Alongside this there were very few reports of pancreatitis and 75% of these had an alternative explanation • GLP-1RAs reduce all the major risk factors for cardiovascular (CV) disease. Meta-analyses of existing randomised controlled trials involving DPP4 inhibitors suggest significant reductions in major CV events alongside no increase in pancreatitis or cancer. The eight, long-term, CV safety studies should clarify the issue with regard to risk and benefits of GLP-1 based therapies as they will record not only CV outcomes but also information on pancreatitis, pancreatic cancer and thyroid cancer • The strength of the data in support of GLP-1 based therapies causing pancreatic damage does not justify the alarm that has been caused to patients taking these therapies. By stopping these agents in response to the scare that has been created, harm to patients may occur because of the discontinuation of the agents in whom they were working well • Pharmaceutical companies should make all relevant data available for inspection by independent experts. Copyright © 2013 John Wiley & Sons.