LONG-TERM EFFECTIVENESS AND SAFETY OF A NUTRACEUTICAL BASED APPROACH TO REDUCE CHOLESTEROLEMIA IN STATIN INTOLERANT SUBJECTS WITH AND WITHOUT METABOLIC SYNDROME.

Cicero, A. F. G.; Derosa, G.; Bove, M.; Imola, F.; Borghi, C.; Gaddi, A. V.

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®, Unilever Italy, Milan, Italy) and one pills of a registered combined nutraceutical (Armolipid Plus®, 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<0.01). In conclusion, a nutraceutical based approach could help the most part patients intolerant to more than one statin to achieve a moderate improvement of their dyslipidemia for at least one year.

FUNCTIONAL foods; HYPERCHOLESTEREMIA treatment; CARDIOVASCULAR diseases; STATINS (Cardiovascular agents); HIGH density lipoproteins; BERBERINE

Current Topics in Nutraceutical Research, 2009, Vol 7, Issue 3, p121

1540-7535

Academic Journal