Polyunsaturated fatty acids of the omega-3-eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) class are referred to as essential fatty acids (NEFIC). Omacor is active against blood plasma lipids, reducing the concentration of triglycerides as a result of a decrease in the concentration of very low density lipoproteins (VLDL). In addition, it actively affects blood pressure and hemostasis, reducing the synthesis of thromboxane A2 and slightly increasing the coagulation time of the blood.There was no significant effect on other coagulation factors.
Omacor reduces the synthesis of triglycerides in the liver, since EPA and DHA are less active substrates for the enzymes responsible for the synthesis of triglycerides, and they inhibit the esterification of other fatty acids. Reducing the concentration of triglycerides is facilitated by an increase in the amount of peroxisomes of β-oxidation of fatty acids (a decrease in the amount of free fatty acids available for the synthesis of triglycerides). Inhibition of this synthesis reduces the level of VLDL.
Omacor increases LDL cholesterol in some patients with hypertriglyceridemia. The increase in the concentration of high-density lipoproteins (HDL) is minimal and significantly lower than after taking fibrates, and is unstable.
The duration of hypolipidemic action when taking Omakor was not studied for more than 1 year. Otherwise, there is no conclusive evidence that lowering the level of triglycerides reduces the risk of developing coronary heart disease.
GISSI-Prevenzione - a multicenter, randomized, open-label clinical trial involving patients who had recently undergone a myocardial infarction (less than 3 months) who received Omacor (n= 2836), and did not take the drug Omakor (n= 2828).The results obtained after 3.5 years of observation on the background of Omakor intake of 1 g per day showed a significant reduction in the criteria of the combined end point, including all-cause mortality, non-fatal myocardial infarction and stroke (15% relative risk reduction 12-26) p = 0.0226) in patients taking Omacor alone compared with the control group. Reduction of pre-defined criteria for a secondary endpoint, including death due to cardiovascular disease, nonfatal myocardial infarction and stroke, was shown (a relative risk reduction of 20% [5-32] p = 0.0082) in patients taking Omacor only with a control group.
In the study GISSI-Heart Failure (GISSI-HF) studied the effect of Omakor drug on reducing mortality and hospitalization in connection with cardiovascular disease in 6975 patients with chronic heart failure (II-IV functional class by classification NYHA), who received standard medication. GISSI-HF - a randomized, double-blind, placebo-controlled study in which patients received 1 g of Omacor per dayn= 3494) or placebo (n= 3481) averaged 3.9 years. The results showed a reduction in the criteria of both end points, including death from all causes (9% relative risk reduction, p = 0.041) and death from all causes and hospitalization due to cardiovascular pathologies (8% relative risk reduction, p = 0.009) . Secondary analysis of the level of primary hospitalization due to ventricular arrhythmias showed a 28% reduction in relative risk (p = 0.013) in the Omakor group compared to the placebo group. The results of subanalysis showed a relative increase in the left ventricular ejection fraction by 8.1%, 11.1% and 11.5% at 1, 2 and 3 years, respectively, in the Omakor-treated group, compared to 6.3%, 8 , 2% and 9.9% in the placebo group (p = 0.005).