European Medicines Agency Finds Little Reason for Concern Over Pancreatic Side Effects in Incretin Therapies
By Kelly Close
Last month, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) released its safety review of incretin-based therapies for diabetes. It concluded that current data do not support an association between incretins and pancreatic side effects (such as pancreatitis or pancreatic cancer). Soon after, the US FDA announced that it has not finished its own review yet, but agrees with the CHMP decision based on current evidence. Incretin therapies include such popular drugs such as the GLP-1 agonists Victoza, Bydureon, and Byetta, as well as the DPP-4 inhibitors Januvia, Onglyza, Tradjenta and Nesina. In Europe, this also includes the GLP-1 agonist Lyxumia and DPP-4 inhibitor Galvus.
The committee highlighted that at this point, there is not enough evidence for new safety concerns, although it does support continued monitoring of patients taking incretin therapies. Merck also issued a press release stating that it will continue to monitor the safety of Januvia (sitagliptin), its DPP-4 inhibitor. For our previous update on incretins and pancreatitis from ADA 2013, see conference pearls in diaTribe #56.
Researchers will probably not be able to prove anytime soon that incretins do or do not cause pancreatitis or pancreatic cancer. Since these are such rare events, rigorously studying them would require large numbers of patients followed over a long period of time. That hasn't been done and might not ever be, given the logistics and costs of conducting such a massive trial. Even the many long-term and large cardiovascular outcomes trial currently going on may be too small or too short – researchers speculate that when enough of these trials are completed, data on pancreatic safety can be combined to gather enough information. If pancreatic risks did exist, we would imagine that they would be very low, which is probably worth the tradeoff given the benefits of the incretin class for so many patients. –NL/KC