A clinical trial of the glucose-control drug sitagliptin among patients with type 2 diabetes and established cardiovascular disease has found it did not raise the risk of major adverse cardiovascular events.
The Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study, conducted by the University of Oxford Diabetes Trials Unit (DTU) and the Duke Clinical Research Institute (DCRI), also found no increased risk of pancreatitis and pancreatic cancer in people receiving sitagliptin.
The results were presented June 8, 2015, at the 75th Scientific Sessions of the American Diabetes Association meeting in Boston, and will be published online in the New England Journal of Medicine the same day. A slide set reflecting the data presented at the American Diabetes Association will be available to download from http://www.dtu.ox.ac.uk/TECOS/ after 6.30 p.m. (ET) on June 8.
Researchers at the DTU and the DCRI compared sitagliptin to placebo in 14,724 patients with type 2 diabetes and established cardiovascular disease between December 2008 and July 2012. The median patient follow-up was approximately three years.
The researchers found that among patients with both type 2 diabetes and established cardiovascular disease, adding sitagliptin to usual care did not increase the risk for hospitalization for heart failure or other adverse cardiovascular events.
Concerns about possible links between hormone-based therapies and effects on the pancreas have been raised. In TECOS, acute pancreatitis and pancreatic cancer were uncommon and not statistically different between groups. Numerically, in the sitagliptin group there were more patients with acute pancreatitis and fewer patients with pancreatic cancer than in the placebo group.
"TECOS provides reassurance that sitagliptin may be used safely to improve blood glucose levels in a diverse group of type 2 diabetes patients at high cardiovascular risk without impacting on rates of cardiovascular complications or heart failure," said Professor Rury Holman of Oxford University, joint chair of the study.
"TECOS is an excellent example of academic and industry collaborative research," said Eric Peterson, M.D., executive director of the DCRI and joint chair of the study.
TECOS was designed, run, and analyzed independently by DTU and DCRI, in an academic collaboration with Merck & Co., Inc., Kenilworth, NJ, USA, (known as MSD outside the United States and Canada), which sponsored and funded the study.
Duke Clinical Research Institute