Abstract
Funding Acknowledgements
Type of funding sources: None.
Introduction. Polyprenols (natural isoprenoid lipids) are precursors of dolichols which is present in every cell and involved in a dolicholphosphate pathway. It seems the polyprenols from plants can be used for a substitution therapy in dolicholphosphate pathway disorders. There is one polyprenol-containing drug in Russia – Ropren® which contains polyprenols isolated by the original method from needles of European spruce. In clinical trials hepatoprotective, hypolipidemic effects of Ropren® in patients with liver pathology and positive effect in alcoholic psychosis and Alzheimer"s disease were founded. Considering that the myocardial infarction is often accompanied by the phenomena of anxiety, depression and decreased cognitive functions that impair prognosis of the disease the search for a drug aimed at reducing the expression of these conditions is relevant.
Purpose. To study the effects of Ropren® on anxiety-depressive condition and cognitive functions in patients with acute coronary syndrome.
Methods. Our registered single-center, randomized, double-blind, placebo-controlled trial "POLYNCOR" were included patients (n = 68) with acute coronary syndrome hospitalized on the first day from the beginning of the symptoms. All patients received standard therapy (including atorvastatin 40 mg) and were randomized on 2 groups: the 1st group (n = 34) received Ropren® 8 drops during а meal 3 times a day (144 mg/day) for 3 weeks then 3 drops 3 times a day (90 mg/day) for 5 weeks; the 2nd group 2 (n = 34) received placebo with the same dosage regimen. On the 3rd, 10th days of hospitalization and after 2 months of therapy the following parameters were analyzed: the level of depression on the CES-D scale, anxiety on the Taylor and Sheehan scales, cognitive functions were assessed on the Montreal Cognitive Assessment Scale (MoCA). Statistical data processing was performed using the Statistica v.10.0 package using nonparametric analysis methods. The results are presented as Me (Q1; Q3).
Results. At discharge there were no differences between groups and the majority of the patients had signs of anxiety, depression and decreased cognitive functions. After 2 months of therapy comparing with the 3rd day of hospitalization the decrease of anxiety score: 2.5 (1.5; 7.5) vs. 15.5 (9,5; 20,5) respectively (p< 0.05) according to Taylor scale and 5.5 (5; 14) vs. 30 (17,5; 39) respectively (p< 0.05) according to Sheehan scale, and depression score: 8 (6.5; 9.5) vs. 18 (15,5; 20,5) respectively (p< 0.05) according to CES-D scale were founded in the study group. Also in the study group cognitive functions score were improved from 23 (21; 25) to 26.5 (25; 28) (p< 0.05) according to MoCA scale.
Conclusion. Polyprenol-containing drug Ropren® contributes to significant reduction of anxiety, depression and improving of cognitive functions in patients with acute coronary syndrome after 2 months of therapy.
RUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome
