The main guidelines for
cardiovascular disease prevention suggest that nutraceuticals could be an efficacious tool to improve
lipid pattern. Our aim was to carry out a clinical trial comparing the metabolic effects of a combined nutraceutical containing both
red yeast rice and
polyunsaturated fatty acids (PUFAs) and a
phytosterol-based approach in a setting of clinical practice. This was a multicenter open study with parallel control. We consecutively enrolled 107 pharmacologically untreated subjects affected by primary polygenic
hypercholesterolemia and
metabolic syndrome, assigned to 8-week treatment with a combined treatment with
red yeast rice (Dif1Stat(®), including 5 mg
monacolin K) and 610 mg PUFAs. A parallel group of 30 subjects with similar characteristics was treated with
phytosterols 1600 mg/die. In the combined nutraceutical group, compared with the baseline level, we observed a significant decrease in total
cholesterol (TC; -42.50 ± 18.1 mg/dL),
low-density lipoprotein cholesterol (
LDL-C; -37.6 ± 13.6 mg/dL),
triglycerides (TG; -19.8 ± 25.1 mg/dL), and non-HDL-C (-43.1 ± 17.7 mg/dL) (all P < .001). In the
phytosterol-treated group, compared to the baseline level, we observed a significant decrease in
TC (-13.7 ± 4.3 mg/dL),
LDL-C (-17.6 ± 8.5 mg/dL), and non-HDL-C (-14.1 ± 5.6 mg/dL) (all P < .001). When comparing the combined nutraceutical effect with that of
phytosterols, we observed that the combined nutraceutical intake was associated with a significantly higher decrease in TC,
LDL-C, TG, and non-HDL-C (all P < .001). In the short term, a combined nutraceutical containing
red yeast rice and PUFAs is well tolerated and efficacious in reducing plasma
lipid levels in subjects affected by primary polygenic
hypercholesterolemia and
metabolic syndrome.