REDUCTION OF CHOLESTEROL WITH NUTRACEUTICAL: RESULTS OF A DOUBLE BLIND STUDY

Abstract

A large body of evidence has demonstrated that LDL-C reduction by statins decrease cardiovascular risk. Statin treatment may also lead to non-lipid effects which may improve vascular protection, including an amelioration of endothelial function. On the other hand, despite a good tolerability demonstrated by several studies, statin treatment may lead to side effects, in particular when higher dosages are used. Alternative hypolipidemic treatments are nutraceuticals which are a food, or part of a food, that provides medical bene ts. Due to the low ef cacy associated to a high tolerability, patients with mild or moderate risk and/or statin-intolerant subjects are the best target of nutraceuticals. Despite a large clinical use, there is a paucity of controlled clinical studies of ef cacy and tolerability of this class of drugs. The purpose of the present study, with a double-blind, parallel group, randomized controlled design was to examine the ef cacy, safety, and tolerability of a nutraceutical product in hypercholesterolemic patients with a mild/ moderate risk previously intolerant to statins or refusing classical pharmaceutical treatments. We also analyzed the pulse wave velocity as expression of arterial stiffness and, indirectly, of endothelial function. Patients received daily either a nutraceutical-combined pill (NCP), containing red yeast rice 200 mg (corresponding to monakoline 3 mg) or placebo for six weeks. We observed a reduction of 10,4% and 12,2% of total cholesterol and LDL-cholesterol respectively. No signi cative variation was observed in the placebo group. Pulse wave velocity signi cantly decreased only in the NCP (-6,5%). Safety parameters did not change during the study and no patient reported myalgia. The mild hypolipidemic effect of red yeast rice is associated to an improvement of arterial function and high tolerability. Therefore we conclude that patients with low or moderate cardiovascular risk and/or statin-intolerant subjects may bene t of this treatment.