Introduction. This article presents experimental data on the study of the possibility of early diagnosis of type 2 diabetes mellitus through the use of lipid-lowering therapy; statins are the drugs of choice. For the treatment of atherogenic dyslipidemia with high triglyceride levels and low concentration of high-density cholesterol (HDL-C), fibrates are traditionally used, including in patients with type 2 diabetes.
Purpose of the study. To evaluate the efficacy and safety of differentiated therapy with atorvastatin, fenofibrate and their combination in patients with type 2 diabetes.
Materials and methods. In clinics № 3 versatile TMA in branch endocrinology therapy and observed 35 patients with newly discovered type 2 diabetes, including 1 7 women and 18 men (mean age of men — 51.2 ± 0.3 years, duration of disease — 1.4 ± 0.49 years, the average age of women was 54.2 ± 0.3 years; the duration of the disease was 0.9 ± 0.51 years). The average level of body mass index (BMI) is 32.6 ± -4.7 kg / m², waist circumference (OT) is 107.2 ± 2.5 cm, waist-to-hip ratio (OT / OT) is 0, 95. The level of total cholesterol and triglycerides was determined by a standard biochemical method, the content of HDL cholesterol was determined by an enzymatic method after precipitation from serum of LDL cholesterol and very low density lipoprotein cholesterol (VLDL cholesterol) with a mixture of phosphotungstic acid with magnesium chloride. The level of LDL cholesterol was calculated using the Fried wald formula: total cholesterol — (HDL cholesterol + TG / 2.2), the type of dyslipidemia was determined according to the Fredrickson classification.
Patients prepared formulations of sulfonylurea 2nd generation and metformin, on insulin readings applied to the achievement level of HbAIc 6.6 ± 0.8 %. After switching to the patients in the study conducted hypoglycemic and antihypertensive therapy is further for 1 year administered atorvastatin 20 mg / day, with hypertriglyceridemia more than 4.5 mmol / l was used fenofibrate. In the absence of achieving target triglyceride values during therapy with atorvastatin, fenofibrate was additionally prescribed. The safety of treatment was monitored by monitoring the activity of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) monthly in the first 3 months, then once every 3 months of treatment.
Results and discussion: Theefficacy and safety of various lipid — lowering drugs (atorvastatin, fenofibrate) and their combination in patients with type 2 diabetes were studied for 7 months.
Atorvastatin at a dose of 20 mg / day effectively reduces the level of total cholesterol, triglycerides and LDL cholesterol after three months of use. We studied the effect of micronized fenofibrate on lipid fractions in patients with type 2 diabetes after 3 months, 0.5 years of use. Therapy with fenofibrate, like atorvastatin, effectively reduces the level of total cholesterol and triglycerides after three months of use, but with a less effective effect on the content of LDL cholesterol.
Combined therapy with atorvastatin and micronized fenofibrate has the most pronounced lipid — lowering effect, 60.0 % of patients with type 2 diabetes after 1 year of use had target levels of both LDL-C, TG, and HDL-C.
The effectiveness of the effect of atorvastatin and fenofibrate on lipid parameters is unequal, therapy with atorvastatin made it possible to achieve the target values of total cholesterol and LDL cholesterol after three months of use, and target TG values only after one year.
The use of lipid — lowering drugs for 1 year does not worsen the state of carbohydrate metabolism, rational antihyperglycemic therapy makes it possible to achieve target HbA1c levels in the group of patients taking lipid — lowering drugs. Fenofibrate is effective in reducing TG levels after three months of therapy, to a lesser extent, affects the value of cholesterol LDL. A tendency to an increase in the level of HDL cholesterol is observed with the use of each of the drugs, to enhance the effect of lipid-lowering therapy, primarily on HDL cholesterol, complex therapy is recommended using a combination of atorvastatin and fenofibrate for at least 1 year.
Conclusions . The study confirmed that treatment with fibrates reduces the severity of retinal exudation by more than 50 %. The 37 % decrease in the need for laser photocoagulation of the retina is explained by the direct effect of fenofibrate on endothelial dysfunction, regardless of the level of glycated hemoglobin (HbA1c), regardless of plasma lipid levels or a slight decrease in blood pressure.
Combined therapy with atorvastatin and micronized fenofibrate has the most pronounced lipid — lowering effect, 60.0 % of patients with type 2 diabetes after 1 year of use had target levels of both LDL-C, TG, and HDL-C. The effectiveness of the effect of atorvastatin and fenofibrate on lipid parameters is unequal, therapy with atorvastatin made it possible to achieve the target values of total cholesterol and LDL cholesterol after three months of use, and target TG values only after one year. Fenofibrate is effective in reducing TG levels after three months of therapy, to a lesser extent, affects the value of cholesterol LDL.
Thus, fenofibrate is the first lipid — lowering drug that has demonstrated the ability to prevent both macrovascular and microvascular complications in patients with type 2 diabetes and optimal glycemic control. Traicor proved to be effective in both primary and secondary prevention, as well as regardless of the presence of dyslipidemia at the initial stage.
- Algorithms of specialized medical care for patients with diabetes mellitus. 9th edition. Ed. I. I. Dedova, M. V. Shestakova. M.,: 2019.
- Batrak G. A. Clinical and functional state of the cardiovascular system in patients with type 2 diabetes mellitus: diagnosis of disorders and their prognostic value: dis.... Dr. med. Sciences: 14.19.04 / Batrak Galina Alekseevna. Ivanovo, 2014.195 p.
- Batrak G. A., Myasoedova S. E. Evaluation of the effectiveness of long — term low-dose therapy with atorvastatin in the prevention of macrovascular complications in elderly patients with type 2 diabetes mellitus. Cardiovascular therapy and prevention, 2010. 9. 3: 68–72.
- Batrak G. A., Myasoedova S. E. Efficacy and safety of fenofibrate in the correction of dyslipidemia in patients with type 2 diabetes mellitus. Preventive medicine, 2010.13.4: 63.
- Dedov I. I. Diabetes mellitus: development of technologies in diagnosis, treatment and prevention (plenary lecture). Diabetes mellitus, 2010.3 (48): 6–13.
- Diagnostics and correction of lipid metabolism disorders in order to prevent and treat atherosclerosis. Russian recommendations, V revision, M., 2012. Russian journal of cardiology, 2012.4 (96): 5–31.