Diabetes Drug Sitagliptin Shows No Increased Risk of Heart Events

Newswise — DURHAM, N.C. – 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.

Notes For Editors

* The American Diabetes Association is holding its 75th Annual Scientific Sessions in Boston, USA, on June 5 – 9 2015. See http://scientificsessions.diabetes.org for more information.

The American Diabetes Association will host a press conference on Sunday June 7, 2 p.m. (ET) in Room 260, Boston Convention and Exhibition Center.Information on accreditation is at: http://professional.diabetes.org/Congress_Display.aspx?TYP=9&CID=60976.

For Remote Access to the Press Conference: 877-407-8293 (toll free in the US).

* The American Diabetes Association is leading the fight to Stop Diabetes® and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. For the past 75 years, our mission has been to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (800-342-2383) or visit diabetes.org. Information from both these sources is available in English and Spanish.

* Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) was an event-driven trial conducted in adults with type 2 diabetes and a history of cardiovascular (CV) disease in a usual care setting. The trial was designed to assess the CV safety of long-term treatment with sitagliptin when added to existing therapy compared with placebo. The primary composite CV outcome was the time to the first confirmed event of CV-related death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. TECOS enrolled 14,724 participants from 38 countries between December 2008 and July 2012 with a median follow-up of three years. See TECOS-study.org

* Funding was provided by Merck & Co., Inc., Kenilworth, NJ, USA, (known as MSD outside the United States and Canada), which markets sitagliptin (JANUVIA®). See www.merck.com

* The Duke Clinical Research Institute (DCRI) is the world's largest academic clinical research organization. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI is also home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding. The DCRI has conducted studies at more than 37,000 sites in 65 countries; completed more than 970 phase I-IV clinical trials, studies of patient outcomes and analyses of comparative effectiveness; managed national patient registries; enrolled more than 1.2 million patients in DCRI studies; and published more than 9,000 papers in peer-reviewed journals.

* The Diabetes Trials Unit (DTU) is a fully registered UKCRC Clinical Trials Unit and a founder member of Oxford Centre for Diabetes, Endocrinology and Metabolism (OCDEM). It is one of only a handful of Academic Research Organisations (AROs) worldwide that specialise in performing diabetes-related mega trials. The DTU designs, runs and analyses large-scale Phase III/IV interventional clinical outcome trials nationally and internationally, often in collaboration with other AROs and pharmaceutical companies. Currently the DTU is undertaking 4 large-scale cardiovascular outcome trials in 40 countries recruiting more than 48,000 patients. See www.dtu.ox.ac.uk.

* OCDEM (Oxford Centre for Diabetes, Endocrinology and Metabolism) is a pioneering centre at Oxford University which combines clinical care, research and education in diabetes, endocrine and metabolic diseases. By promoting world-class research, it aims to enhance understanding of these diseases and to accelerate the search for new treatments and cures. See www.ocdem.ox.ac.uk