From left: Dr. Adel Bashandi, MSD Saudi Arabia Business Unit, director for cardiovascular & metabolic diseases department; Dr. Saleh Al Jasser, Consultant Endocrinologist, KFNG- Riyadh; and Prof. Murad Elmourad, Consultant Endocrinologist, King Saud University Hospital, Riyadh, Saudi Arabia
RIYADH — Cardiovascular disease (CVD) is now recognized as the leading cause of death and disability worldwide. Along with the rapid socioeconomic growth in the Gulf countries, there has been a change in lifestyle such as an increased consumption of poor quality foods and the adoption of a sedentary lifestyle, and as a consequence the rates of CVD and associated risk factors among the Gulf population have also increased. In the long term, if the disease is not controlled, it will eventually affect not just the patient, but the economy as a whole. Against this backdrop, research and development studies continue to explore for treatment. Lately, MSD, known as Merck in the US and Canada, has announced the primary results of Tecos, a placebo-controlled study of the cardiovascular (CV) safety of MSD's DPP-4 inhibitor, Januvia (sitagliptin). The results of trial evaluating cardiovascular outcomes (Tecos) show that sitagliptin does not increase the risk of cardiovascular events in a diverse group of patients with type 2 diabetes at high cardiovascular risk. At a symposium held in Riyadh recently, medical professors who are CVD consultants themselves, said 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 (JANUVIA) 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. Treatment with sitagliptin, a DPP-4 inhibitor, versus placebo for median 3 years in 14,671 patients with type 2 diabetes (T2DM) and established cardiovascular (CV) disease showed non-inferiority for the primary composite cardiovascular endpoint of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), and no increase in hospitalization for heart failure in the sitagliptin group. Researchers at the University of Oxford Diabetes Trials Unit (DTU) and the Duke Clinical Research Institute (DCRI) have found that among patients with T2DM and established CV disease, addition of sitagliptin to usual care did not impact on the risk for major adverse CV events, hospitalization for heart failure or adverse events. Concerns about possible links between incretin-based therapies and effects on the pancreas have been raised. In TECOS, acute pancreatitis and pancreatic cancer were uncommon and not statistically significant 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. Professor Rury Holman of Oxford University, Joint Chair of the study, commented 'TECOS provides reassurance that sitagliptin may be used safely to improve blood glucose levels in a diverse group of T2DM patients at high cardiovascular risk without impacting on rates of cardiovascular complications or heart failure.' Professor Eric Peterson, DCRI Executive Director at Duke University and Joint Chair of the study, stated: 'TECOS is an excellent example of academic and industry collaborative research.' Overall, the primary endpoint occurred in 11.4 per cent (n=839) of sitagliptin-treated patients compared with 11.6 per cent (n=851) of placebo-treated patients in the Intention-to-Treat (ITT) analysis, and in 9.6 per cent (n=695) of patients in both the sitagliptin and placebo groups in the Per Protocol (PP) analysis. 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), who sponsored and funded the study. — SG
