A group of British diabetologists has backed the use of glucagon-like peptide (GLP)-1 based therapies in some patients with diabetes, refuting concerns the drugs may be linked with pancreatic adverse events.
In a position statement, the Association of British Clinical Diabetologists (ABCD) said evidence the agents – also known as incretins – cause pancreatic damage is lacking, and that discontinuing their use could end up harming patients who currently benefit from taking them.
The ABCD said its own nationwide audits of incretin use in the UK show the drugs are associated with improvements in glycaemic control and weight loss, as well as reductions in use of other diabetes therapies, in particular insulin, while there have been few reports of pancreatitis – most of which have alternative explanations.
The association also said one recent study showing an increased risk of acute pancreatitis with incretins is ‘open to criticism’ because of residual confounding and is not supported by other observational studies, while results from adverse event reporting systems data are unreliable because of ‘notoriety bias’. Meanwhile, animal data are ‘inconsistent’, while human histological data are ‘preliminary and open to alternative explanations’, it added.
The EMA’s review came at a time of intense debate over the link between incretins and pancreatic adverse events, resulting in a joint investigation by the BMJ and Channel 4’s Dispatches programme that suggested the pharmaceutical industry and regulators have downplayed the potential risk.
But the ABCD says the ‘strength of 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’ and that ‘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’.
According to the association, eight ongoing long-term cardiovascular safety trials of incretins should clarify the issue, as they will also provide pancreatitis, pancreatic cancer and thyroid cancer outcomes data. Nevertheless, the ABCD also called on pharmaceutical companies to ‘make all relevant data available for inspection by independent experts’.