Duke: 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
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.