Objectives: We planned to carry out a pilot study to evaluate the efficacy and safety as an antihypercholesterolemic agent of a brand dietary supplement made of Monascus purpureus titrated extract, octacosanols and niacin on 111 Caucasian patients with low cardiovascular disease risk (<20% by Framingham algorithms), comparing them with the antihypercholesterolemic effect of a low dosage of Pravastatin on 20 subjects with similar risk profile.
Results: In our study, the tested dietary supplement determined a significant decrease of Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG) in moderately hypercholesterolemic subjects without clinically relevant change in liver and muscular toxicity markers. The reduction of LDL-C reached the 20%, and it is similar to that obtained with a well-known effective statin like Pravastatin.
Conclusions: Further long-term and double blind evaluation have to be carried out before to infer the observed results, however it appears that the studied dietary supplements could be a safe and efficacious antihypercholesterolemic agent for patients at low risk for cardiovascular diseases.