Effects of policosanol on borderline to mildly elevated serum total cholesterol levels: a prospective, double-blind, placebo-controlled, parallel-group, comparative study

Abstract

Background: Hypercholesterolemia is a major risk factor for coronary heart disease. Clinical studies have shown that lowering elevated serum cholesterol levels, particularly low-density lipoprotein cholesterol (LDL-C), is beneficial for patients with borderline to mildly elevated serum total cholesterol (TC) levels (5.0-6.0 mmol/L). Policosanol is a cholesterol-lowering drug made from purified sugar cane wax. The therapeutic range of policosanol is 5 to 20 mg/d.Objective: This study investigated the efficacy and tolerability of policosanol 5 mg/d in patients with borderline to mildly elevated serum TC levels.Methods: This 14-week, single-center, prospective, double-blind, placebocontrolled, parallel-group, comparative study was conducted in men and women aged 25 to 75 years with a serum TC level Ն4.8 to Ͻ6.0 mmol/L. After a 6-week run-in period in which patients were placed on therapeutic lifestyle changes, in particular a cholesterol-lowering diet, patients were randomly assigned to receive policosanol 5-mg tablets or placebo tablets once daily with the evening meal for 8 weeks, and the diet was continued throughout the study. Lipid profile variables, safety indicators, adverse events (AEs), and compliance with study medications were assessed.Results: One hundred patients (71 women, 29 men; mean [SD] age, 52 [10] years) entered the study after the dietary run-in period. After 8 weeks of treatment, the mean (SD) serum LDL-C level decreased significantly in the policosanol group (P Ͻ 0.001 vs baseline and placebo) from 3.57 (0.30) mmol/L to 2.86 (0.41) mmol/L (change, Ϫ19.9%). Significantly more patients in the policosanol group The percentage changes were significantly different between the policosanol and placebo groups for serum LDL-C, TC, and HDL-C levels (P Ͻ 0.001, P Ͻ 0.001, and P Ͻ 0.05, respectively), but not for TG. In the placebo group, changes in lipid profile variables from baseline were not significant. Policosanol did not significantly impair any safety indicator and was well tolerated. Three patients (3%) (1 patient [2%] in the policosanol group; 2 patients [4%] in the placebo group) withdrew from the trial, none because of AEs. Two patients (1 patient [2%] each in the policosanol and placebo groups) withdrew from the study because of an unwillingness to return for follow-up; 1 patient (2%) in the placebo group had a change of address and could not be followed up. Overall, 4 patients (4%) (1 patient [2%] in the policosanol group; 3 [6%], placebo) reported AEs; all were mild. Of the patients who received placebo and reported AEs, all 3 (6%) experienced heartburn, and 1 (2%) also experienced dry skin, while the policosanol-treated patient (2%) who reported an AE experienced headache. Conclusions:In this study of patients with borderline to mildly elevated serum TC levels, based on the criterion that Ն70% of policosanol-treated patients reached the LDL-C goal of a decrease Ն15% from baseline whenever this proportion was different with respect to placebo, 8 weeks of treatment with policosanol ...

Red Yeast Rice for the Improvement of Lipid Profiles in Mild-to-Moderate Hypercholesterolemia: A Narrative Review

“…One of the most extensively studied RYR nutraceutical combinations (Armolipid Plus ® ) includes berberine, a plant alkaloid that enhances the hepatic uptake of cholesterol, for which the largest pharmacovigilance datasets are available [ 75 , 76 , 77 ]. Armolipid Plus ® contains 3 mg monacolin K, 500 mg berberine, and 10 mg policosanols (aliphatic alcohols derived from sugar cane, reported to have cholesterol-lowering effects [ 78 ]). A meta-analysis of 12 randomized control trials involving 1050 subjects with up to 12 months’ follow-up showed that this preparation significantly decreased body-mass index (MD −0.25 kg/m 2 ; p = 0.008), LDL-C (MD −26.67 mg/dL; p < 0.001), TC (MD −25.07 mg/dL; p < 0.001), triglycerides (MD −11.47 mg/dL; p < 0.001), fasting glucose (MD −3.52 mg/dL; p < 0.001), and hs-CRP versus placebo (−0.61 mg/L; p = 0.022), and significantly increased HDL-C (MD 1.84 mg/dL; p < 0.001) versus placebo [ 76 ].…”

Effects of a policosanol supplement on serum lipid concentrations in hypercholesterolaemic and heterozygous familial hypercholesterolaemic subjects

“…Based on an expected LDL-C-lowering effect of at least 20 % (Castano et al 2002b(Castano et al , 2003c, this number of subjects would have provided at least 80 % power at a 5 % level of significance. The subjects signed informed consent forms for participation in the study.…”

Cuban policosanol improves high-density lipoprotein cholesterol efflux capacity in healthy Japanese subjects

“…HDL concentration reduction is partially known to be related to aging ( 46 ); however, some centenarians presented with higher HDL-C levels ( 47 ), suggesting the association between high HDL levels, anti-atherosclerosis, and longevity. Policosanol supplementation reportedly elevated the HDL-C levels remarkably ( 48 ) and tendentially ( 49 ) in animal models and significantly in human studies ( 15 , 22 , 50 ). In this study, the effect of policosanol in increasing the HDL-C levels concurs with the above reports ( Figure 1B ).…”