A large body of evidence has demonstrated that LDL-C reductionby statins decrease cardiovascular risk. Statin treatment may alsolead to non-lipid effects which may improve vascular protection,including an amelioration of endothelial function. On the otherhand, despite a good tolerability demonstrated by several studies,statin treatment may lead to side effects, in particular whenhigher dosages are used. Alternative hypolipidemic treatments arenutraceuticals which are a food, or part of a food, that providesmedical bene ts. Due to the low ef cacy associated to a high tolerability,patients with mild or moderate risk and/or statin-intolerantsubjects are the best target of nutraceuticals. Despite a large clinicaluse, there is a paucity of controlled clinical studies of ef cacyand tolerability of this class of drugs. The purpose of the presentstudy, with a double-blind, parallel group, randomized controlleddesign was to examine the ef cacy, safety, and tolerability of a nutraceuticalproduct in hypercholesterolemic patients with a mild/moderate risk previously intolerant to statins or refusing classicalpharmaceutical treatments.We also analyzed the pulse wave velocity as expression of arterialstiffness and, indirectly, of endothelial function. Patients receiveddaily either a nutraceutical-combined pill (NCP), containing redyeast rice 200 mg (corresponding to monakoline 3 mg) or placebofor six weeks. We observed a reduction of 10,4% and 12,2% of totalcholesterol and LDL-cholesterol respectively. No signi cativevariation was observed in the placebo group. Pulse wave velocitysigni cantly decreased only in the NCP (-6,5%). Safety parametersdid not change during the study and no patient reported myalgia.The mild hypolipidemic effect of red yeast rice is associated to animprovement of arterial function and high tolerability. Thereforewe conclude that patients with low or moderate cardiovascular riskand/or statin-intolerant subjects may bene t of this treatment.
|Number of pages||1|
|Publication status||Published - 2013|