Effects of Nutraceutical Therapies on Endothelial Function, Platelet Aggregation, and Coronary Flow Reserve

Hypercholesterolemia is considered one of the most important cardiovascular risk factors. Cardiovascular prevention include a class I indication to statins in addition to non-pharmacologic intervention and prevention strategies in patients deemed to be \'high risk\'. Along with non-pharmacologic intervention and prevention strategies, newer approaches to reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived from foods with cholesterol lowering actions. However, it remains unclear if nutraceuticals yield additive positive effects other than cholesterol lowering. In particular, there is evidence that Berberine has cardiovascular protective effects and that, in vitro, Morus Alba, mulberry fruit, modulates platelet function by inhibiting platelet activation, thromboxane formation, serotonin secretion, aggregation and thrombus formation. Furthermore, Morus Alba exerts an α-glucosidase inhibitory and antioxidant activity in vitro, which may reduce postprandial glucose peak, thus improving HbA1c concentration. Accordingly, we designated a study to evaluate the effects of two commercially available nutraceutical combined pills \[LopiGLIK™, Akademy Pharma, 1 capsule/day containing red yeast rice 220 mg (at least 3,3 mg of Monacolin K) + Berberine 531,25 mg + Morus Alba 200 mg (at least 4 mg of Deoxynojirimycin) vs. Armolipid Plus®, Meda Pharma, 1 capsule/day containing Berberis aristata d.e. 588 mg (equivalent to Berberine chloride 500 mg) + Red yeast rice 200 mg (equivalent to Monacolin K 3 mg) + Policosanol 10 mg + Folic acid 0.2 mg + Coenzyme Q10 2.0 mg + Astaxanthin 0.5 mg\] on lipid and metabolic profile, platelet aggregation, endothelial function and coronary flow reserve (CFR). For this purpose patients with hypercholesterolemia not requiring statins or statin intolerant at moderate cardiovascular risk will be subjected at day 0 and at day 28, after 4 weeks of therapy, to blood sampling to evaluate lipid and metabolic profile, peripheral arterial tonometry (EndoPAT), platelet aggregation tests with light transmission aggregometry (LTA), nitric oxide (NO) release, endothelial nitric oxide synthase (eNOS) phosphorylation on platelets. Only for CFR, patients will be further evaluated also after two hours from the administration of the first dose of nutraceutical combined pill. Patients will be randomly assigned to receive therapy with LopiGLIK™ or with Armolipid Plus®.