Long-term efficacy and tolerability of a largely marketed multicomponent nutraceutical in overweight and normoweight dyslipidaemic patients.

The short-term lipid-lowering activity of some nutraceuticals is well-known, however there is a lack of knowledge about their long-term effect, especially as it regards insulin-resistance parameters and biomarkers of vascular health. This study is a 12-months follow-up randomized clinical trial carried out on 269 non smoker hyperlipidaemic patients in primary prevention for cardiovascular disease, 214 of them (129 men and 85 women) completed the trial with a good compliance. All the subjects were non diabetics nor treated with antihyperlipidaemic drugs. 79 normoweight subjects (Group1) were treated with a combined nutraceutical (Armolipid Plus ® - ALP, Rottapharm-Madaus SpA, Monza, I) associated with a standardized TLS (therapeutic life-style as in the definition of third Adult Treatment Panel of the National Cholesterol Education Program), 85 overweight with ALP-TLS (Group 2), and 50 overweight with just intensified TLS (Group 3). Efficacy parameters (BMI, FPG, FPI, HOMA index,MMP-2, MMP-9, TIMP-1, TIMP-2, TC, LDL-C,HDL-C, TG) were evaluated every 4 months. Educational reinforcements were also planned every 4 months. This study demonstrated the long-term efficacy and safety of a combined nutraceutical added to therapeutic life-style in overweight and normoweight dyslipidaemic subjects; berberine and red yeast rice based nutraceuticals showed efficacy on body weight reduction and insulin-sensitivity promotion in non diabetic hyperlipidaemic patients; favourable effects of a combined nutraceutical added to therapeutic life-style were observed on biomarkers of vascular remodelling in overweight and normoweight dyslipidaemic subjects