Efficacy of a combination of natural lipid-lowering and antioxidant agents in hypercholesterolaemic patients

Background The use of statins has allowed significant progress in the management of risk factors and a striking reduction of deaths from coronary disease. Nevertheless, more widespread use of statins is restricted by side effects and the refusal of patients. Design A prospective open label trial. Methods We investigated the effects of a combination of natural lipid-lowering and antioxidant agents containing policosanols from rice (10 mg), red yeast rice (200 mg), Extramel® (5 mg), phytosterols (50 mg), polyphenols from olive (10 mg), polyphenols from grape seed (10 mg) and folic acid (0.2 mg) on 60 hypercholesterolaemic patients. Results After 12 weeks the therapy produced an −11% average change from baseline in total cholesterol (total-C) levels (from 253.8±30.6 to 227.2±33.7 mg/dl, p <0.0001). The average low-density lipoprotein cholesterol (LDL-C) reduction was about 18% (from 169.3±35.8 to 144.4±31.7 mg/dl, p <0.0001). The changes in high-density lipoprotein cholesterol and triglycerides were not statistically significant. After 24 weeks these results were maintained, with a further small reduction of total-C levels and LDL-C levels. Conclusions A combination of natural active lipid-lowering agent and antioxidant agents induced a significant reduction in total-C and LDL-C levels after 12 weeks of treatment; the effect was maintained at 24 weeks, with no side effects during the whole observation.