CONGRESS ABSTRACT

Background: Cardiovascular disease is a global health concern and reducing plasma LDL-C levels is a major goal in cardiovascular prevention. Our study aimed to evaluate the effectiveness of a nutraceutical formulation including leucoselect® phytosome®, red yeast rice, policosanol and folic acid on LDL-c levels in patients at low cardiovascular risk with dyslipidemia. Materials and Methods: We prospectively enrolled all consecutive patients with dyslipidemia at low cardiovascular risk who were unresponsive to diet and physical activity. Clinical assessments and laboratory analyses, encompassing lipid profile, hepatic function, and CPK levels, were performed at baseline prior to initiating treatment and repeated at the 12-week mark following administration of the study nutraceutical. Results: Sixty (60) consecutive patients (mean age 48.02 ± 10.1 years; 60% male) were included. At the 12-week follow-up, a statistically significant reduction in Total Cholesterol (13.1%) and LDL-c serum level (20.4%) was observed. Hepatic and muscular function remain stable over the time. The adherence to therapy was 99% and the persistence was maximum. Discussion: The main findings of the present study are as follows: the use of a nutraceutical formulation including leucoselect® phytosome®, red yeast rice, policosanol and folic acid determines a significant reduction of 20% in the LDL-C serum level among patients at low cardiovascular risk with dyslipidaemia not responsive to diet and physical exercise; 75% of treated patients achieved the LDL-C therapeutical level within 12 weeks of treatments. The use of this novel nutraceutical combination is safe and well-tolerated in a real-world setting and it is characterized by maximum persistence and high adherence. A pleiotropic effect on inflammatory biomarkers has been shown. Conclusions: The nutraceutical formulation including leucoselect® phytosome® red yeast rice, policosanol and folic acid significantly reduced the LDL-c plasma levels, consistent with previous research showing that the bioactive component in red yeast rice—lovastatin—is effective in addressing problems with lipid metabolism. Importantly, it was safe and well-tolerated among patients with dyslipidemia in a real-world setting.