The treatment of hypercholesterolemic children: Efficacy and safety of a combination of red yeast rice extract and policosanols

Background and aims: The prevention of cardiovascular risk, as occurs in lipoprotein disorders, is required since childhood. Aim of the study was to evaluate, in a group of children affected by primary dyslipidemia, the efficacy, tolerability and safety of a short-term treatment with a dietary supplement containing red yeast rice extract and policosanols. Methods and Results: 40 children affected by heterozygous Familial Hypercholesterolemia (FH) (n = 24) and Familial Combined Hyperlipidemia (FCH) (n = 16), aged 8-16 years, were enrolled in a double-blind, randomized, placebo-controlled, cross-over trial. After a 4-week run-in period with only dietary advice, children received a dietary supplement containing 200 mg red yeast rice extract, corresponding to 3 mg of monacolins, and 10 mg policosanols once-daily and placebo for 8 weeks, separated by a 4-week washout period. Lipid profile was assessed after each treatment period. The dietary supplement, compared with the placebo, significantly reduced total cholesterol by 18.5% (p < 0.001), LDL-C levels by 25.1% (p < 0.001), and apolipoprotein B by 25.3% (p < 0.001) when patients were considered as a whole group. Similar results were obtained when FH and FCH were considered separately and no significant difference between groups was detected. No significant differences were observed in HDL-C and apolipoprotein A-I levels. No adverse effects were detected when liver and muscular enzymes (AST, ALT, and CK) were determined. Conclusions: The treatment with a dietary supplement containing red yeast rice extract and policosanols has been for the first time successfully employed in hypercholesterolemic children. Results indicate this strategy as an effective, safe and well tolerated in a short-term trial. (C) 2009 Published by Elsevier B.V.