Endocrine Abstracts

Objective: To evaluate the alterations of fibrosis biomarkers during empagliflozin treatment in patients with type 2 diabetes mellitus (T2DM) and a very high risk of cardiovascular events.

Materials and methods: Twenty-six patients with type 2 diabetes mellitus received 10 mg of empagliflozin within 24 weeks. Inclusion criteria: women and men aged 18 to 70 years with T2DM, glycated hemoglobin (HbA1c) 7.0–11.0%, stable hypoglycemic therapy at least 12 weeks before inclusion in the study, the presence of cardiovascular risk factors. Exclusion criteria: the presence of coronary heart disease, chronic heart failure or other clinically significant cardiovascular diseases, estimated glomerular filtration rate (GFR), according to CKD-EPI (GFR < 60 ml/min/1.73 m².). HbA1c, creatinine, galectin-3, tissue inhibitor of metalloproteinase-1 (TIMP-1), carboxyterminal propeptide of collagen type I (P1CP), matrix metalloproteinase-9 (MMP-9), ST-2, NT-proBNP, total cholesterol, LDL, HDL, triglycerides (TG) were evaluated.

Results: The age of the patients was 52 years (45–61), the HbA1c level at the time of the study inclusion was 8.6% (7.7–9.5), BMI 32.1 kg/m² (29.9–34.9). After 24 weeks of treatment, there was a significant decrease of HbA1c – 7.8% (7.2–8.1), P = 0.0001 and BMI – 31.0 kg/m² (29.3–33.6), P = 0.002. There were no significant differences between the concentrations of galectin-3 before treatment and after 24 weeks of treatment – 8.6 ng/ml (7.2–10.9) and 10.4 ng/ml (6.6–13.2), P = 0.571. Significant differences were observed between the initial P1CP concentration ​​and P1CP concentration ​​after 24 weeks of treatment – 120.4 ng/ml (114.2–168.8) and 104.4 ng/ml (89.0–168.8) (P = 0.019). However, after applying the Holm-Bonferroni, the differences were not significant. The concentrations of TIMP-1 after 6 months did not significantly differ compared with the initial values, 210 ng/ml (177–226) and 208 ng/ml (172–240), respectively, P = 0.861. A significant negative correlation was obtained between the LDL concentration after 6 months of treatment and the ST-2 concentration after 6 months of treatment (LDL and ST (r = −0.883, P = 0.002). A positive correlation was found between the initial concentration of galectin-3 and the initial concentration ​​of SST (r = 0.501, P = 0.02).

Conclusions: Empagliflozin therapy for 24 weeks does not lead to a significant changes in fibrosis biomarkers, such as galectin-3, TIMP-1, P1CP, MMP-9, ST-2 in patients with type 2 diabetes and a very high risk of cardiovascular events.