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Francesco Di Pierro,1 Pietro Putignano,2 Tarcisio Ferrara,3 Carmela Raiola,4 Giuliana Rapacioli,5 Nicola Villanova6 1Scientific Department, Velleja Research, Milan, Italy; 2Outpatient Diabetic Clinic, University Hospital San Gerardo, Monza, Italy; 3District 63, Cava de’ Tirreni-Costa d’Amalfi, Salerno, Italy; 4Outpatient Clinic “Ordine di Malta”, Naples, Italy; 5AIOR, Piacenza, Italy; 6Metabolic Disorders, S. Orsola Malpighi Hospital, Bologna, Italy Background: Berberis aristata, because of its berberine content, and Monascus purpureus fermented rice, because of the presence of monacolins (naturally derived statins), are widely investigated food-grade ingredients used to formulate cholesterol-lowering supplements. Although they are extensively used, berberine is poorly absorbed and monacolins are poorly chemically characterized, not standardized, and possibly contaminated with toxic compounds. Silymarin is reported to enhance berberine absorption, while Monakopure™-K20 (MK-20) is a highly standardized red yeast rice containing monacolins K and KA in the ratio of 1:1 but not secondary monacolins, dehydromonacolins, or citrinin.Aim: The effects of a cholesterol-lowering supplement (Berberol®K) containing berberine, silymarin, and MK-20 (BSM) in patients with dyslipidemia were clinically analyzed.Methods: The clinical role of BSM in naïve and in statin-intolerant patients was retrospectively evaluated and the effects observed were compared with those obtained in patients without treatment or treated with lovastatin.Results: Total cholesterol, low density lipoprotein, and triglyceride levels were approximately 4%, 6%, and 11% lower, respectively, and the creatine phosphokinase increase was reduced in patients treated with BSM compared to those treated with lovastatin. Similar results were also obtained in statin-intolerant subjects where BSM was administered as add-on therapy to ezetimibe or fenofibrate. Conclusion: BSM is a food supplement potentially useful 1) as a primary intervention in low-cardiovascular-risk subjects with dyslipidemia; 2) as add-on therapy in mildly statin-intolerant patients; and 3) in dyslipidemic patients with a negative perception of statins who prefer a treatment seen as natural. Keywords: berberine, Berberol®K, silymarin, P-glycoprotein, cholesterol, triglycerides, Monascus purpureus, Monakopure™-K20