A recent study is helping to fuel safety concerns surrounding Onglyza. The research, which was presented this past December at the World Diabetes Congress 2015, suggested that patients using Onglyza and other DPP-4 inhibitor medications might face a small, but significantly increased risk of acute pancreatitis.
According to a report from MedScape.com, the study consisted of a meta-analysis of three earlier clinical trials involving Onglyza, Januvia and Nesina. All three medications lower blood sugar levels in Type 2 diabetics by blocking an enzyme that’s responsible for inactivating incretin hormones in the gut. Incretins stimulate the pancreas to produce more insulin.
According to a report from MedScape.com, concerns that DPP-4 inhibitors might harm the pancreas have existed since 2009. And in 2013, the British Medical Journalcharged that drug makers had downplayed the risk for all incretin-based medications, including DPP-4 ihibitors. But a subsequent investigation undertaken by a U.S. National Institutes of Health panel found no clear signal.
According to the authors of this new research, the number of patients with acute pancreatitis was higher with the study drug than placebo in all three clinical trials analyzed. While the incidence failed to reach statistical significance for the purposes of any single study,the hazard ration for all three combined did reach statistical significance.
“The data suggest a small increased risk of acute pancreatitis from all the DPP-4 inhibitors. It’s a very uncommon event. Nevertheless, if you had patients with previous risk factors for pancreatitis, you might be more cautious,” Rury R Holman, MD, director of the University of Oxford Diabetes Trials and lead author of the analysis told Medscape Medical News.
In 2014, the U.S. Food & Drug Administration (FDA) began a safety review of Onglyza after data from the SAVOR TMI clinical trial suggested that patients using the medication faced a 27% increase in hospitalizations for heart failure, as well as a higher risk of all-cause mortality. This past April, the agency’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14-to-1 to recommend that new information regarding a potential association with heart failure be added to the Onglyza label. While the FDA is not required to follow the recommendations of its advisory panels, it usually does so.