The aim of this open randomized study was to compare the clinical efficacy of
mildronate in complex
therapy of chronic
heart failure (CHF) and basic
therapy in patients with CHF and
type 2 diabetes mellitus (DM2) during the postinfarction period. The subjects were 60 II to III NYHA CHF patients aged 43 to 70 yo also suffering from DM2; the patients were observed during the early postinfarction period (weeks 3 to 4 from the onset of
myocardial infarction). The patients were randomized into two groups: the 30 patients of the main group received basic
therapy plus
mildronate in a dose of 1 g a day, while the 30 patients of the control group received basic
therapy only. The observation lasted 16 weeks. The following parameters were measured dynamically: NYHA functional class (FC), 6-min walking test results, left ventricular ejection fraction (LVEF), LV isovolumic relaxation time, microalbuminuria, glomerular filtration speed (GFS), functional renal reserve (FRR),
carbohydrate and
lipid exchange, cardiac rhythm variability parameters, and the quality of life. The use of
mildronate in addition to basic
therapy was associated with a more evident decrease in CHF FC, (by 19% vs. 14%), increase in 6-min walking test distance (25.5% vs. 18%), as well as a tendency to normalization of diastolic heart function and an increase in LVEF (by 12% vs. 7%). By comparison with basic
therapy, the patients in the
mildronate group displayed a statistically significant improvement in renal functioning: GFS increased by 20% vs. 2% (p < 0.05), the proportion of patients with an exhausted FRR decreased (p < 0.05), the average level of MAU decreased significantly (24% vs. 9%, p < 0.05). In the main group, a significant decrease in blood
triglyceride level (by 33%, p < 0.05) and total
cholesterol level (by 28%, p < 0.1) was noted. A hypoglycemizing ability of
mildronate was noted. The use of
mildronate in the basic
therapy favors the normalization of vegetative homeostasis and improves the quality of life.