Abstract
Abstract Aims Current guidelines recommend the use of lipid lowering agents based on the patient's cardiovascular risk. In the last years, a great interest was driven towards the cathegory of "very low risk" patients, in which a single cardiovascular risk factor is sufficient to make them been considered at "relatively higher" risk. For the last category of patients nutraceutical acquired importance in the last years. The present study aims to evaluate the efficacy and safety of a combination of monacolin K 2.9 mg, (fermented yest rice), coenzyme Q10 30 mg (Formulation A) versus monacolin K 10 mg, and coenzyme Q10 10 mg (Formulation B) on lipidic profile and on the vascular function evaluated as endothelial function and arterial stiffness. Methods The present is a single-center, open-label randomized controlled parallel group study to compare efficacy and safety of two different type of nutraceutical compounds (Formulation A or Formulation B). Patients enrolled were with low cardiovascular risk, in primary prevention, in order to evaluate the evolution of the lipidic profile of these patients and the impact of a nutraceutical-based treatment strategy. Patients eligible for the study were randomized 1:1 to receive either a pill day of Formulation A or B. Results Both treatments with Formulation A or B were tolerated; no patients reported side effects or withdrew from the study. The two groups were balanced with respect clinical and biochemical variables. After 24 weeks of treatment we demonstrated a statistically significant reduction in total cholesterol (p 0.010) and LDL (p 0.002). We observed also an improvement in endothelial function (p 0.292) and a reduction of arterial stiffness (p 0.209) evaluated through the non-invasive methods of EndoPAT and SphygmoCOR. Data obtained suggest monacolin K 2.9 mg, coenzyme Q10 30 mg and rice policosanols 20 mg (Formulation A), was non inferiority to monacolin K 10 mg, coenzyme Q10 10 mg (Formulation B) in endothelial function improvement and serum lipids lowering. Conclusions The new combination of natural nutraceuticals, have a protective cardiovascular effect, not also through reduction of plasma lipids but also in endothelial function and arterial stiffness, despite the reduction of monacolin K.
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