Abstract
Increased non high-density lipoprotein (HDL)/low-density lipoprotein (LDL) cholesterol levels are independent risk factors for cardiovascular (CV) mortality with no documented threshold. A new combination of nutraceuticals (berberine 200 mg, monacolin K 3 mg, chitosan 10 mg and coenzyme Q 10 mg) with additive lipid-lowering properties has become available. The aim of the study is to test the efficacy of the nutraceutical formulation (one daily) in lowering non-HDL cholesterol vs. placebo at 12 weeks in individuals with non-HDL-cholesterol levels ≥160 mg/dL. 39 subjects (age 52 ± 11 years; 54% females; body mass index 27 ± 4 kg/m2) were randomized (3:1) in a double blind phase II placebo-controlled study. At baseline, 4 and 12 weeks main clinical/biohumoral parameters, pro-inflammatory cytokines, (gut)-hormones, proprotein convertase subtilisin/kexin type 9 (PCSK9) levels and endothelial progenitor cell (EPC) number were assessed. Baseline characteristics were comparable in the two groups. The intervention significantly decreased non-HDL cholesterol (−30 ± 20 mg/dL; p = 0.012), LDL cholesterol (−31 ± 18 mg/dL, p = 0.011) and apolipoprotein (Apo) B (−14 ± 12 mg/dL, p = 0.030) levels compared to the placebo. Pro-inflammatory, hormonal, PCSK9 and EPC levels remained stable throughout the study in both groups. The intervention was well tolerated. Three adverse events occurred: Epstein Barr virus infection, duodenitis and asymptomatic but significant increase in creatine phosphokinase (following intense physical exercise) which required hospitalization. The tested nutraceutical formulation may represent a possible therapeutic strategy in dyslipidemic individuals in primary prevention.
Highlights
Increased cholesterol levels are an established cardiovascular (CV) risk factor linearly associated with CV outcomes with no documented threshold [1,2]
This study shows that this nutraceutical formulation was effective in the reduction of non-high-density lipoprotein (HDL)/low-density lipoprotein (LDL)-C levels
This double blind, randomized placebo-controlled study shows that a 12-week treatment with a newly available nutraceutical formulation—containing a combination of compounds with putative complementary lipid-lowering properties—was effective in reducing plasma non-HDL-C and LDL-C compared to the placebo, without affecting proprotein convertase subtilisin/kexin type 9 (PCSK9) bioavailability in individuals with hypercholesterolemia
Summary
Increased cholesterol levels are an established cardiovascular (CV) risk factor linearly associated with CV outcomes with no documented threshold [1,2]. In a meta-analysis including over 90,000 individuals, each 1 mmol/L (38.7 mg/dL) decrease in low-density lipoprotein (LDL)-cholesterol (LDL-C) levels with statin therapy yielded a 23% reduction in the risk of major coronary events over five years [3]. Non-high-density lipoprotein cholesterol (non HDL-C) emerged as a new target for lipid lowering therapy as, compared to LDL-C, it includes all atherogenic cholesterol (triglyceride-rich lipoprotein, very low density lipoprotein, chylomicron remnants and intermediate-density lipoprotein). The recent development of the plasma proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors has highlighted the importance of PCSK9 as a new therapeutic target for lowering LDL-C and dyslipidemia-associated CV disease (CVD) [9]. Emerging evidence demonstrated that statin therapy is associated with an undesirable significant increase in plasma PCSK9 irrespective of type of statin and treatment duration, and that its combination therapy with ezetimibe may further increase PCSK9 compared to statin alone, blunting lipid-lowering and cardioprotective actions of statins, and, perhaps of ezetimibe [11]
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