This pilot study evaluated the antihypercholesterolaemic efficacy and safety of a brand dietary supplement made of Monascus purpureus (red yeast rice) titrated extract, octacosanols and niacin on 111 Caucasian patients with low cardiovascular disease risk receiving the supplement were compared with the anti-hypercholesterolaemic effect of a low dosage of Pravastatin on 20 subjects with similar risk profile. The tested dietary supplement was associated with a significant decrease in total cholesterol, LDL-C and triglycerides in moderately hypercholesterolaemic subjects without a clinically relevant change in liver and muscular toxicity markers. The reduction of LDL-C reached 20%, and it is similar to that obtained with a well-known effective statin like Pravastatin.