Long-term effectiveness and safety of a nutraceutical based approach to reduce cholesterolemia in statin intolerant subjects with and without metabolic syndrome.

The aim of our study was to test the long-term effectiveness and tolerability of a nutraceutical based approach in reducing cholesterolemia in statin intolerant subjects with and without metabolic syndrome in primary prevention for cardiovascular disease. We carried out a prospective, clinical trial enrolling 48 subjects intolerant to more than one statin. Patients assumed one yogurt added with 2 g phytostanols each morning (Pro-Activ (R), Unilever Italy, Milan, Italy) and one pills of a registered combined nutraceutical (Armolipid Plus (R), Rottapharm-Madaus Srl, Monza, Italy) containing Berberine 500 mg and Monacoline 3 mg. Four patients dropped out from the study because of side effects (2 asymptomatic increase in CPK>5 ULN, 1 myalgia, 1 dyspepsia). After 3 months, total cholesterol decreased by 22.3 +/- 5.8%, LDL-C by 31.3 +/- 8.3%, TG by 16.11 +/- 10.7% (all, p<0.01): these reduction were confirmed each 3 month until 1-year. Fasting glycaemia decreased from the baseline only after 1-year of treatment by a 10.6 +/- 4.6% (p<0.05). Patient affected (N. 27) by metabolic syndrome also experienced a significant increase in HDL-C plasma level (p