Recently, The Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) was presented at the 75th Scientific Session of American Diabetes Association. The study indicated that the dipeptidyl peptidase 4 (DPP-4) inhibitor sitagliptin did not increase the risk of cardiovascular complications and hospitalization due to heart failure when used for treating type 2 diabetes patients with a history of cardiovascular complications.
is an oral hypoglycemic agent or drug used to treat diabetes which is marketed by Merck & Co and was approved by US FDA in the year 2006. It acts by inhibiting the enzyme dipeptidyl peptidase-4 (DDP-4), which destroys hormones called incretins in the body. The incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide) decrease glucagon level and increase insulin secretion. Thus, by preventing the degradation of incretins, sitagliptin reduces blood sugar. The Trial Evaluating Cardiovascular Outcomes with Sitagliptin was a large-scale follow-up study that observed 14,671 participants enrolled at 673 sites in 38 countries.
All the patients had type 2 diabetes
with established cardiovascular disease and were at least 50 years old. History of major coronary artery disease, stroke, or atherosclerotic disease was considered as an established cardiovascular disease. Average glycated hemoglobin (HbA1c), which estimates diabetes control, for the participants at baseline was 7.2%. The participants were randomly divided in two study groups wherein one group received sitagliptin added to the existing diabetes therapy, while the other group received added placebo. The primary outcome for the study included the first confirmed event of cardiovascular death, nonfatal heart attack, nonfatal stroke, unstable angina, or hospitalization for heart failure
. No significant difference was found between the sitagliptin group and the placebo group for these primary outcomes.
Earlier studies have correlated incretin-based therapies such as sitagliptin and saxagliptin with increased risk of pancreatic ailments. However, in TECOS, no statistically significant rates of pancreatitis and pancreatic cancer was found in patients taking the sitagliptin as compared to the placebo group.
TECOS, conducted by the University of Oxford Diabetes Trials Unit (DTU) and the Duke Clinical Research Institute (DCRI), therefore, suggested that sitagliptin can be used safely for managing blood glucose levels in type 2 diabetes patients with established cardiovascular diseases without further increasing the risk of cardiovascular complications
and related hospitalizations.
The study is now published in The New England Journal of Medicine and is open for review of diabetic patients and the doctors treating them. It was funded by Merck Sharp & Dohme.