Long Term Efficacy and Tolerability of a Nutraceutical Combination (Red Yeast Rice, Policosanols and Berberine) in Low-moderate Risk Hypercholesterolemic Patients: a Double-blind, Placebo Controlled Study

Background: Statins are at the forefront of strategies to manage hypercholesterolemia. However, 10-15% of patients result to be intolerant to any statins, even at low daily doses and almost one- third of statin users discontinue therapy within one year. Some nutraceuticals are prescribed as lipid- lowering substances, but doubts remain about their efficacy and tolerability. In this study we investigated the effects of a nutraceutical combination consisting mainly of red yeast rice extract 200 mg (equivalent to 3 mg monacolins), berberine 500 mg and policosanols 10 mg (MBP-NC). Methods: In this single centre, randomized, double-blind, placebo-controlled study 60 consecutive outpatients (age range: 18-60 years), with newly diagnosed primary hypercholesterolemia not previously treated, after a run-in period of 3 weeks on a stable hypolipidic diet, were randomized to receive a pill of MBP-NC (N=30) or placebo (N=30) once a day after dinner, in addition to the hypolipidic diet. The efficacy and the tolerability of the proposed nutraceutical treatment were fully assessed after 4, 12 and 24 weeks of treatment.