1. Introduction
hypercholesterolemia, cardiovascular disease
ADVERSE EVENTS, HYPERCHOLESTEROLEMIA, CARDIOVASCULAR DISEASE, DYSLIPIDEMIA
Certain nutraceuticals, mainly containing red yeast rice, might be considered as an alternative therapy to statins in patients with dyslipidemia, although there is still insufficient evidence available with respect to long-term safety and effectiveness on cardiovascular disease prevention and treatment. The aim of this study was to assess the lipid-lowering activity and safety of a dietary supplement containing a low dose of monacolin K combined with coenzyme Q10, grape seed and olive tree leaf extracts in patients with mild hypercholesterolemia. In total, 105 subjects with mild hypercholesterolemia (low-density lipoprotein cholesterol LDL-C levels 140–180 mg/dL) and low CV risk were randomly assigned into three treatment groups: lifestyle modification (LM), LM plus a low dosage of monacolin K (3 mg), and LM plus a high dosage of monacolin K (10 mg) and treated for 8 weeks. The primary endpoint was the reduction of LDL-C and total cholesterol (TC). LDL-C decreased by 26.46% on average (Lowering of the LDL concentration produces benefits in cardiovascular disease prevention equivalent to the percentage of the LDL cholesterol (LDL-C) lowering and the final LDL-C concentration achieved, independent of the modality used to obtain that reduction [Red yeast rice (RYR) is a well-known food ingredient in many Asian countries, often utilized in the preparation of various foods, such as fish, meat, and rice wine [Extracts of RYR, and its chief bioactive compound monacolin K, are currently considered the most efficacious cholesterol-lowering nutraceutical. Previous intervention studies have indicated that RYR containing 5 to 10 mg monacolin K can lower elevated LDL-C levels by 22% to 27% [The combination of nutraceuticals allows achieving LDL-C reductions by using lower doses of each component and thus reduces the likelihood of adverse events related to a single component [The aim of this study was to assess the lipid-lowering activity and safety of a novel, commercially available dietary supplement containing a low dose of monacolin (3 mg) combined with CoQ10, OLE), GSE, and vitamin B complex in volunteers with moderate elevations in LDL-C concentrations and low cardiovascular risk.