STUDY ON THE EFFECTIVENESS AND TOLERABILITY OF THE “ALTSYNARA” DIETARY SUPPLEMENT IN PATIENTS WITH HYPERCHOLESTEROLEMIA

Abstract

The article presents the results of a clinical study on the effectiveness and tolerability of DD “Altsynara” produced by PJSC “Bor-shchagivskyi HFZ” in comparison with placebo in volunteers with hypercholesterolemia. Volunteers of the main (30 people) and control groups (30 people) received DD “Alcinara” on an outpatient basis for 90 days, 2 tablets 3 times a day, and placebo (2 tablets 3 times a day for 90 days), respectively. Evaluation of the effectiveness of DD “Altsinara”/Placebo was carried out 45±2 and 91±2 days after the start of taking DD “Altsinara”/Placebo based on the dynamics of lipidogram indicators; tolerability was assessed based on registration and analysis of adverse reactions/ adverse events. According to the obtained results, DD “Altsinara” contributes to the improvement of the lipid profile in volunteers with hypercholesterolemia after 3 months of administration, which is evidenced by a statistically significant difference between the groups according to the main criterion of effectiveness – the proportion of volunteers assigned to the “Use is effective” category. The hypolipidemic effect of DD “Alcinara” is manifested not only in lowering the level of low-density lipoproteins, but also triglycerides. The studied product is able to increase the content of highdensity lipoproteins, the decrease of which is a separate predictor of the development and progression of atherosclerosis. Undesirable side effects when taking the studied products occurred in a total of 23.7% of volunteers and were noted in each group without statistically significant differences in frequency. The most common occurrence was dyspepsia (16.13% of cases) and headache – 16.13% of cases. Thus, the hypolipidemic effect of DD “Alcinara” can be considered proven, therefore its use as a special food product for long-term use by persons with hypercholesterolemia and/or persons with a tendency to hypercholesterolemia (burdened family history, excess body weight, irrational nutrition, diabetes, etc.) will reduce the risk of developing atherosclerosis and its fatal consequences.