Treatment of children with high cholesterol: Efficacy and safety of a combination of Red Yeast Rice Extract and Policosanol

March 01, 2010

     Researchers at the Department of Pediatrics, University of Turin in Italy state that to prevent cardiovascular disease which occurs with blood fat disorders, it is required to treat the condition from childhood. The aim of this 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 Policosanol.
     40 children affected by heterozygous Familial Hypercholesterolemia (FH) or Familial Combined Hyperlipidemia (FCH), 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 200mg Red Yeast Rice Extract, corresponding to 3mg of monacolins, and 10mg Policosanol once-daily and then switched to placebo or vice versa 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%, LDL-Cholesterol by 25.1%, and apolipoprotein B by 25.3% 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.
     The treatment with a dietary supplement containing Red Yeast Rice Extract and Policosanol 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. The study is published in the February 10th, 2010 issue of the journal Nutrition, Metabolism and Cardiovascular Diseases.