Efficacy and safety of combined hypoglycemic therapy in the diabetes mellitus type 2 in combination with coronary heart disease
AbstractIntroduction. Diabetes is a serious medical and social problem of all countries and of all ages. The combination of the diabetes mellitus type 2 and coronary heart disease according to some data is near 70–80% among patients with diabetes. The most significant risk factor for development of cardiovascular complications is bad glycemic control, as confirmed in various basic researches. In modern diabetology all the big attention is given not only point measurements and fixing points of hyperglycemia or hypoglycemia but to circadian excursions blood glucose, that may become predictors of cardio-vascular events. One of the perspective trends in pharmacotherapy of the type 2 diabetes is incretins mechanisms of regulation of glucose homeostasis, which have physiologic glucose-dependent hypoglycemic effect. In order to effectively and safety improve glycemic control in diabetes mellitus type 2 patients requires careful study of different variant of combination hypoglycemic therapy.
Objective. To evaluate the efficacy and safety of glycemic control in patients with diabetes mellitus type 2 and coronary heart disease in the application of the DPP-4 inhibitors in combination with metformin.
Materials and methods. In the study will be included the patients with diabetes mellitus type 2 and stable coronary heart disease, in the stage of decompensation (HbA1c>7%), under the monotherapy with metformin (maximum daily dose 2000 mg). On the first stage of the research will be conducted clinical examination, laboratory tests, including clinical and biochemical blood analysis, determination of markers of oxidative stress, continuous glucose monitoring (CGMS), monitoring of ECG with calculation of variability heart rhythm. At the second stage of the research will be conducted correction of antidiabetic therapy with the purpose of improvement of glycemic control. All the patients will be in 2 groups randomized. All the patients will be in two groups randomised. In the first group of patients sitagliptin will be added to the therapy with metformin. In the second group to the monotherapy with metformin will be added glibenclamid. The threatment duration will last 3 months followed by the follow-up period. During the follow-up the patients will become previous therapy.
Expected results. During research it is planned to assess the change of the level of variability of glycemia in study groups, and to achieve the maximum physiological range of variability of glycemia. The obtained data will allow to identify the preferable oral hypoglycemic medications in patients with diabetes mellitus type 2 and coronary heart disease, as well as to clarify criteria for assessing prognosis of coronary heart disease in patients of this category.
Keywords:diabetes mellitus type 2, stable CHD, continuous glucose monitoring, heart rate variability