Efficacy and Tolerability of a Nutraceutical Combination (Red Yeast Rice, Policosanols, and Berberine) in Patients with Low-Moderate Risk Hypercholesterolemia: A Double-Blind, Placebo-Controlled Study

Abstract

BackgroundStatins are at the forefront of strategies to manage hypercholesterolemia. However 10% to 15% of patients are intolerant to any statin drugs, even at low daily doses and almost one-third of statin users discontinue therapy within 1 year. Some nutraceuticals are prescribed as lipid-lowering substances, but doubts remain about their efficacy and tolerability.ObjectivesWe aimed to investigate the efficacy and the safety of a nutraceutical combination consisting mainly of 200 mg red yeast rice extract (equivalent to 3 mg monacolins), 500 mg berberine, and 10 mg policosanols (MBP-NC) in patients with low-moderate risk hypercholesterolemia.MethodsIn this single centre, randomized, double-blind, placebo-controlled study 60 consecutive outpatients (29 men and 31 women; age range = 18–60 years), with newly diagnosed primary hypercholesterolemia not previously treated, after a run-in period of 3 weeks on a stable hypolipidic diet, were randomized to receive a pill of MBP-NC (n = 30) or placebo (n = 30) once a day after dinner, in addition to the hypolipidic diet. The efficacy and the tolerability of the proposed nutraceutical treatment were fully assessed after 4, 12, and 24 weeks of treatment.ResultsIn the MBP-NC group both total cholesterol and LDL-C already showed a significant reduction at Week 4 (–30.3% ± 33.9% and –29.4% ± 35.3%, respectively) that remained substantially unchanged at Week 12 (–26.7% ± 33.1% and –25.6% ± 31.5%, respectively) and at Week 24 (–24.6% ± 32.1% and –23.7% ± 32.6%, respectively). The between-groups differences were significant at all time points for both total cholesterol and LDL-C. There were no significant changes in HDL-C, fasting glucose, and triglyceride serum levels in either group. MBP-NC was also safe and well tolerated.ConclusionsIn patients with low- to moderate-risk hypercholesterolemia a nutraceutical combination in association with a hypolipidic diet significantly reduced total cholesterol and LDL-C levels and may favor the reaching the recommended cholesterol targets. ClinicalTrials.gov identifier: NCT02078167.

Effect of Monacolin K and COQ10 supplementation in hypertensive and hypercholesterolemic subjects with metabolic syndrome

“…These changes were higher than the improvement obtained with diet alone. In agreement with Gonelli et al, no significant increase of HDL-C was found after treatment with Liposcudil Plus [15]. This finding may be related to higher levels of HDL-C at baseline of our subjects, intrinsic characteristics of the subjects enrolled and to the duration of treatment.…”

Nutraceuticals for Serum Lipid and Blood Pressure Control in Hypertensive and Hypercholesterolemic Subjects at Low Cardiovascular Risk

“…Our results are in agreement with recent studies [23,24] where NCs showed a significant effect in lowering TC, LDL-C and TG. However, in disagreement with Trimarco et al [25], but in agreement with Gonelli et al [28] and Li et al [10], no significant increase of HDL-C was found after treatment with NCs. This finding may be related to higher levels of HDL-C at baseline of our subjects, intrinsic characteristics of the subjects enrolled, the doses of the NCs used, and to the duration of treatment.…”

Berberine and barberry (Berberis vulgaris): A clinical review

“…A similar combination to Armolipid Plus that contains 500 mg berberine, 200 mg red yeast rice extract (equivalent to 3 mg monacolins), and 10 mg policosanols has been tested in a single center, randomized, double‐blind, placebo‐controlled study in 60 patients with newly diagnosed primary hypercholesterolemia not previously treated. TC and LDL‐C was significantly reduced at Week 24 (−24.6% ± 32.1% and −23.7% ± 32.6%, respectively; Gonnelli et al, ). This combination also has shown effective in a large parallel, controlled, randomized, multicenter study in 1,751 dyslipidemic patients (Trimarco et al, ).…”

“…Statins are drugs of first choice in hypercholesterolemic patients. However, 10% to 15% of patients are intolerant to statins, even at low doses and about one‐third of statin consumers have to cease the therapy within 1 year (Gonnelli et al, ). Alternate agents to statins are needed in these patients.…”