Effects of Rice Policosanol in Hypercholesterolaemic Patients
Effects of Rice Policosanol in Hypercholesterolaemic Patients
Background: Policosanol is an agent that includes mixtures of aliphatic primary alcohols extracted primarily from sugar-cane wax. This mixture has been shown to lower total and low-density lipoprotein (LDL) cholesterol in animal models, healthy volunteers and hypercholesterolaemic patients.
Patients and Methods: This study investigated the efficacy and tolerability of rice policosanol (Oryza sp.) 10 mg/day in 70 hypercholesterolaemic patients of both sexes aged 2078 years in a randomised, double-blind, crossover, placebo-controlled, single-centre trial. After an 8-week run-in period during which patients were placed on therapeutic lifestyle changes, in particular a cholesterol-lowering diet, they were randomly assigned to receive rice policosanol 10mg tablets or placebo tablets once daily with the evening meal for 8 weeks. During the next 8 weeks those patients who received policosanol during the first 8 weeks received placebo, and those who received placebo during the first 8 weeks, received policosanol. Total, LDL, high-density lipoprotein (HDL), HDL2 and HDL3 cholesterol, triglycerides, oxidised LDL (ox-LDL), apoproteins (Apos) AI and B, lipoprotein (a) [Lp(a)], fibrinogen, homocysteine and C-reactive protein (CRP) levels were measured.
Results: Rice policosanol significantly reduced plasma total cholesterol from 7.37 ± 1.42 mmol/L to 6.99 ± 1.33 mmol/L (p = 0.007) and increased Apo AI from 1.49 ± 0.39 mmol/L to 1.58 ± 0.38 mmol/L (p = 0.037) but did not change plasma triglycerides, HDL, HDL2, HDL3 and LDL cholesterol, ox-LDL, Lp(a), Apo B, fibrinogen, homocysteine or CRP levels.
Conclusion: Rice policosanol 10 mg/day moderately decreased plasma total cholesterol and increased Apo AI. Rice policosanol was also well tolerated, with no drug-related effects on safety parameters such as serum aminotransferases and creatine phosphokinase detected or found on physical examination.
Coronary heart disease (CHD) is the leading cause of death in established market economies and the number of patients with CHD in low- and average-income populations is also large and increasing. Dyslipidaemia, particularly elevated total and low-density lipoprotein (LDL)-cholesterol and decreased high-density lipoprotein (HDL)-cholesterol, is a major risk factor for CHD. Large randomised clinical trials have clearly shown that lowering elevated total and LDL-cholesterol reduces morbidity and mortality in the primary and secondary prevention of CHD. Therefore lipid-lowering treatment is the focus of current approaches to the prevention of CHD. Because of concerns regarding adverse effects and some patients' reluctance to be treated with chemically derived lipid-lowering drugs, alternative naturally derived agents have become increasingly popular over the last decade. One of these agents is policosanol a natural mixture of aliphatic primary alcohols isolated from sugar-cane (Saccharum officinarum L) wax. Its main components are octacosanol (62.9%), triacontanol (12.6%) and hexacosanol (6.2%). Other alcohols (tetra- cosanol, heptacosanol, nonacosanol, dotriacontanol and tetriacontanol) are minor components. Sugar-cane policosanol has been reported to lower total and LDL-cholesterol in healthy volunteers, in patients with mild hypercholesterolaemia and those with type II hypercholesterolaemia, in elderly and adolescent hypercholesterolaemic patients, and in hypercholesterolaemic patients with type II diabetes.
The precise mechanism of total and LDL-cholesterol reduction by sugar-cane policosanol remains unclear, but inhibition of cholesterol synthesis, increased hepatic uptake, and increased LDL catabolism seem to play a role. It also seems that policosanol has the ability to increase HDL-cholesterol. In several trials, sugar-cane policosanol has been compared with the effects of established lipid-lowering drugs, such as HMG CoA reductase inhibitors (statins) and fibrates. The results suggest similar efficacy to simvastatin, pravastatin, lovastatin and even atorvastatin. However, despite all these effects of sugar-cane policosanol, to date there has been no study demonstrating significant efficacy on clinical CHD endpoints, although several studies demonstrated an improvement in initial and absolute claudication distance with policosanol. All of these studies have been performed only with sugar-cane policosanol and in very few centres, exclusively Cuba and Argentina.
The aim of our study was to investigate the effects of rice policosanol (Oryza sp.) on serum lipids, lipoproteins, apoproteins and oxidised LDL-particles as well as on fibrinogen, C-reactive protein (CRP) and homocysteine.
Background: Policosanol is an agent that includes mixtures of aliphatic primary alcohols extracted primarily from sugar-cane wax. This mixture has been shown to lower total and low-density lipoprotein (LDL) cholesterol in animal models, healthy volunteers and hypercholesterolaemic patients.
Patients and Methods: This study investigated the efficacy and tolerability of rice policosanol (Oryza sp.) 10 mg/day in 70 hypercholesterolaemic patients of both sexes aged 2078 years in a randomised, double-blind, crossover, placebo-controlled, single-centre trial. After an 8-week run-in period during which patients were placed on therapeutic lifestyle changes, in particular a cholesterol-lowering diet, they were randomly assigned to receive rice policosanol 10mg tablets or placebo tablets once daily with the evening meal for 8 weeks. During the next 8 weeks those patients who received policosanol during the first 8 weeks received placebo, and those who received placebo during the first 8 weeks, received policosanol. Total, LDL, high-density lipoprotein (HDL), HDL2 and HDL3 cholesterol, triglycerides, oxidised LDL (ox-LDL), apoproteins (Apos) AI and B, lipoprotein (a) [Lp(a)], fibrinogen, homocysteine and C-reactive protein (CRP) levels were measured.
Results: Rice policosanol significantly reduced plasma total cholesterol from 7.37 ± 1.42 mmol/L to 6.99 ± 1.33 mmol/L (p = 0.007) and increased Apo AI from 1.49 ± 0.39 mmol/L to 1.58 ± 0.38 mmol/L (p = 0.037) but did not change plasma triglycerides, HDL, HDL2, HDL3 and LDL cholesterol, ox-LDL, Lp(a), Apo B, fibrinogen, homocysteine or CRP levels.
Conclusion: Rice policosanol 10 mg/day moderately decreased plasma total cholesterol and increased Apo AI. Rice policosanol was also well tolerated, with no drug-related effects on safety parameters such as serum aminotransferases and creatine phosphokinase detected or found on physical examination.
Coronary heart disease (CHD) is the leading cause of death in established market economies and the number of patients with CHD in low- and average-income populations is also large and increasing. Dyslipidaemia, particularly elevated total and low-density lipoprotein (LDL)-cholesterol and decreased high-density lipoprotein (HDL)-cholesterol, is a major risk factor for CHD. Large randomised clinical trials have clearly shown that lowering elevated total and LDL-cholesterol reduces morbidity and mortality in the primary and secondary prevention of CHD. Therefore lipid-lowering treatment is the focus of current approaches to the prevention of CHD. Because of concerns regarding adverse effects and some patients' reluctance to be treated with chemically derived lipid-lowering drugs, alternative naturally derived agents have become increasingly popular over the last decade. One of these agents is policosanol a natural mixture of aliphatic primary alcohols isolated from sugar-cane (Saccharum officinarum L) wax. Its main components are octacosanol (62.9%), triacontanol (12.6%) and hexacosanol (6.2%). Other alcohols (tetra- cosanol, heptacosanol, nonacosanol, dotriacontanol and tetriacontanol) are minor components. Sugar-cane policosanol has been reported to lower total and LDL-cholesterol in healthy volunteers, in patients with mild hypercholesterolaemia and those with type II hypercholesterolaemia, in elderly and adolescent hypercholesterolaemic patients, and in hypercholesterolaemic patients with type II diabetes.
The precise mechanism of total and LDL-cholesterol reduction by sugar-cane policosanol remains unclear, but inhibition of cholesterol synthesis, increased hepatic uptake, and increased LDL catabolism seem to play a role. It also seems that policosanol has the ability to increase HDL-cholesterol. In several trials, sugar-cane policosanol has been compared with the effects of established lipid-lowering drugs, such as HMG CoA reductase inhibitors (statins) and fibrates. The results suggest similar efficacy to simvastatin, pravastatin, lovastatin and even atorvastatin. However, despite all these effects of sugar-cane policosanol, to date there has been no study demonstrating significant efficacy on clinical CHD endpoints, although several studies demonstrated an improvement in initial and absolute claudication distance with policosanol. All of these studies have been performed only with sugar-cane policosanol and in very few centres, exclusively Cuba and Argentina.
The aim of our study was to investigate the effects of rice policosanol (Oryza sp.) on serum lipids, lipoproteins, apoproteins and oxidised LDL-particles as well as on fibrinogen, C-reactive protein (CRP) and homocysteine.