Abstract
Hypercholesterolemia represents a serious public health problem as it significantly increases the risk of developing cardiovascular diseases. Its treatment with statin is limited by costs, side effects, and drugs interactions. Nutraceuticals appear to have an important metabolic effect on cholesterol reduction as well as on body weight and glycemia. The aim of this study was to evaluate the effect of a nutraceutical combination (Melasterol) in eighty-seven patients with acquired hypercholesterolemia. Clinically relevant parameters were collected at baseline and after three and six months of Melasterol treatment, one tablet per day. The primary endpoint was the change in cholesterol and triglyceride levels. Six months of treatment resulted in a 19.2% decrease in total cholesterol, accompanied by a 19.8% decrease in low-density lipoprotein (LDL) and a 23% reduction in triglycerides (p < 0.001) but not in high-density lipoprotein (HDL) levels (p > 0.05). These results were paralleled by a significative blood glucose (108.3 ± 21.3 vs. 98.4 ± 18.6 mg/dL p < 0.001) and body mass index (BMI) reduction (27.8 ± 4.4 vs. 27.0 ± 4.2 mg/dL, p < 0.001). A subgroup of 12 patients performed flow-mediated dilation, with values increasing by 1.8% (p < 0.05). No significant side effects were reported. Besides its cholesterol-lowering effect, Melasterol was associated with a significant improvement in other relevant metabolic parameters such as BMI and glycemia.
Highlights
Hypercholesterolemia represents a serious public health problem as it significantly increases the incidence of cardiovascular diseases (CVD), the first cause of morbidity and mortality worldwide [1,2]
Nutraceuticals should be considered in monotherapy in patients with mild–moderate hypercholesterolemia and low–moderate cardiovascular risk; in monotherapy and in combination in case of lack of any other possibilities to achieve the low-density lipoprotein (LDL) cholesterol (LDL-C) targets with statin and non-statin agents, including in high-risk patients with complete or partial statin intolerance who have not reached LDL-C goal with tolerable statin therapy and/or non-statin therapy [5,6,7]
These results suggest a potential role of Melasterol in patients with mild hypercholesterolemia and obesity and/or impaired glucose metabolism
Summary
Hypercholesterolemia represents a serious public health problem as it significantly increases the incidence of cardiovascular diseases (CVD), the first cause of morbidity and mortality worldwide [1,2]. Lifestyle modifications are suggested in all patients with dyslipidemia, regardless of risk class [5] They are based on the consumption of healthy functional foods and/or dietary supplements [5,6,7]. The use of statins is limited by their relevant interactions with other drugs and side effects, so that many researchers are investigating effective and safer alternative treatments [5,6,7,8]. In this context, nutraceuticals represent an emerging trend in healthcare for their metabolic effects on cholesterol and ancillary parameters such as body weight and glycemia. Nutraceuticals should be considered in monotherapy in patients with mild–moderate hypercholesterolemia and low–moderate cardiovascular risk; in monotherapy and in combination in case of lack of any other possibilities to achieve the LDL cholesterol (LDL-C) targets with statin and non-statin agents, including in high-risk patients with complete or partial statin intolerance who have not reached LDL-C goal with tolerable statin therapy and/or non-statin therapy [5,6,7]
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