Effectiveness and safety of red yeast rice predominated by monacolin K β-hydroxy acid form for hyperlipidemia treatment and management

OBJECTIVE:To assess the lipid-lowering activity and safety of a dietary supplement containing monacolin K β-hydroxy acid form(MKA),Heye(Folium Nelumbinis),and Cangzhu(Rhizoma Atractylodis Lanceae),compared to lifestyle modifications.METHODS:Totally 117 subjects with moderate to severe dyslipidemia(according to Chinese guidelines)and low CV risk were randomly assigned into three treatment groups:lifestyle modification(LM),LM plus a low dosage of MKA,LM plus a high dosage of MKA,and treated for 60 d.The primary endpoint was the reduction of low density lipoprotein cholesterol(LDL-C)and total cholesterol(TC).Safeties along with Traditional Chinese Medicine Syndromes were assessed through the study.RESULTS:A low dosage of MKA along with lifestyle modifications caused a significant decrease in LDL-C by 15.6％on average(95％Cl,9.6％to 21％)with,a decrease in TC by 15.3％on average(95％Cl,9.26％to 21.4％),and a decrease in non-HDL-C by 35.4％(95％Cl,25.76％to 41.34％).Weak evidence of a reduction of triglycerides but an increment of HDL-C was observed in patients with severe hyperlipidemia.No severe adverse events occurred during the study.CONCLUSION:Our results confirm the LDL-C and TC lowering properties of MKA is clinically meaningful.It also produces a significant reduction of non-HDL-C,and slightly effects on TG and HDL-C as well.