EFFECTIVENESS AND SAFETY OF NUTRACEUTICAL COMPOUNDS ADDED TO EZETIMIBE TREATMENT IN HYPERTENSIVE AND HYPER–CHOLESTEROLEMIC SUBJECTS WITH STATIN–INTOLERANCE

Abstract

Objective: The effectiveness of statins in the primary and secondary prevention of cardiovascular (CV) diseases has been widely proven. However, the onset of adverse events associated with their use, prevents to achieve the therapeutic targets recommended by the guidelines (GL) for the management of dyslipidaemia. In the event of statin intolerance, is recommend to use bile acid sequestrants, fibrates and ezetimibe in monotherapy, but their benefits in improving lipid pattern are quite modest. This study aims at evaluating the effectiveness and safety of a nutraceutical compound (NC) associated with ezetimibe (E) on the lipid profile in statin-intolerant patients with moderate-to-high CV risk Design and method: Ninety-six statin-intolerant hypertensive and hyper-cholesterolemic subjects treated with E 10 mg daily, were randomised in open label (n = 48) to take for 3 months a NC containing Monacolin K (MK) 5 mg, Berberine Hydrochloride, t-Resveratrol, Quercetin, and Chromium, in the form of a gastro-resistant tablet that improves enteric bio-accessibility and bio-availability of these substances. The control group (n = 48), took only E in monotherapy at the same dosage; both groups followed a standardised lipid-lowering diet. The total serum cholesterol (TC), low density lipoprotein cholesterol (LDLC), high density lipoprotein cholesterol (HDLC), triglycerides (TG), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine phosphokinase (CPK) levels were compared at the follow-up in both groups using Student's t-test. Results: TC and LDL levels reduced in both groups, but there lower in the group treated with E+ NC vs E alone (-25.9 vs -15%, p < 0.05 and -38.7 vs. -21.0%, p < 0.05, respectively). No changes were observed in either group regarding to a decrease in TG (-9.4 vs. -11.7%, NS) and an increase in HDLC (+ 4.2 vs. +1.1%, NS). The AST, ALT and CPK levels increased in the E + NC compared to the control group, but were still within the acceptable range. There was no difference for the lipid-lowering treatment between gender, and no patient withdrawn the study. Conclusions: In hypertensive and hyper-cholesterolemic subjects with statin-intolerance, the E + NC combination therapy is well-tolerated and effective in the short term in improving TC and LDLC levels.