DPP-4 inhibitor sitagliptin meets primary endpoint for CV outcomes in TECOS Trial
28/04/2015
In the TECOS-trial (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) with the DPP-4 inhibitor sitagliptin, the primary endpoint of non-inferiority for the composite cardiovascular endpoint was met.
SourceNews - Apr. 28, 2015
In the TECOS-trial (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) with the DPP-4 inhibitor sitagliptin (Januvia®), the primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint was met.
Among secondary endpoints, there was no increase in hospitalization for heart failure in the sitagliptin group versus placebo.
Sitagliptin is indicated to improve glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise.
TECOS was an event-driven trial to assess the cardiovascular outcome of long term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin. The trial was conducted in adults > 50 years with type 2 diabetes, a HbA1c of 6.5% to 8.0%, and a history of cardiovascular disease.
The primary endpoint was the time to first confirmed cardiovascular (CV) event (a composite defined as CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization).
Secondary endpoints were: time to first confirmed cardiovascular (CV) event (a composite defined as CV-related death, nonfatal MI, or nonfatal stroke), time to all-cause mortality, time to congestive heart failure, and change in renal function over time.
In TECOS, 14,724 participants from 38 countries were enrolled between December 2008 and July 2012. The median patient follow-up was approximately three years.
The complete results of TECOS will be presented on June 8, 2015 at the 75th Scientific Sessions of the American Diabetes Association.
Press release Merck April 27, 2015
Among secondary endpoints, there was no increase in hospitalization for heart failure in the sitagliptin group versus placebo.
Sitagliptin is indicated to improve glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise.
TECOS was an event-driven trial to assess the cardiovascular outcome of long term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin. The trial was conducted in adults > 50 years with type 2 diabetes, a HbA1c of 6.5% to 8.0%, and a history of cardiovascular disease.
The primary endpoint was the time to first confirmed cardiovascular (CV) event (a composite defined as CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization).
Secondary endpoints were: time to first confirmed cardiovascular (CV) event (a composite defined as CV-related death, nonfatal MI, or nonfatal stroke), time to all-cause mortality, time to congestive heart failure, and change in renal function over time.
In TECOS, 14,724 participants from 38 countries were enrolled between December 2008 and July 2012. The median patient follow-up was approximately three years.
The complete results of TECOS will be presented on June 8, 2015 at the 75th Scientific Sessions of the American Diabetes Association.
Press release Merck April 27, 2015