The most effective Policosanol, and the one used in the original research, is a natural supplement derived from sugar cane.
In clinical research trials of more than 30,000 persons it has been shown to significantly improve cholesterol ratios, and most importanly the good HDL cholesterol.
These well-designed clinical trials have included short and long-term, randomized, double-blind studies comparing policosanol to a placebo as well as double-blind comparative trials versus statin drugs.
In the studies Policosanol produced cholesterol-lowering effects within the first 6-8 weeks of use. At a daily dosage of 10-20 mg of policosanol at night, LDL cholesterol levels typically dropped by 20 to 30% within the first six months of therapy.
The research study concluded;"Low HDL is an independent risk factor for CAD in case-control and prospective observational studies.In clinical studies of policosanol HDL cholesterol levels typically increase by 15 to 25% after only two months of use.
In contrast, high HDL levels are associated with longevity and are protective against the development of atherosclerotic disease. In the Framingham Study, risk for CAD increases sharply as HDL levels fall progressively below 40 mg/dL."
The combined LDL reduction and HDL increase can produce dramatic improvements in the LDL to HDL ratio, which lowers risk of a heart attack or stroke!
Policosanol is a mixture of fatty alcohols derived from the wax of sugarcane .(Saccharum officinarum, L.) These active substances work to lower cholesterol levels by several mechanisms including blocking the formation of cholesterol in the liver. The components of policosanol include 1-octacosanol, 1-dotriacontanol, 1-triacontanol, 1- tetracosanol, 1-tetratriacontanol, 1-hexacosanol, 1-heptacosanol and 1-nonacosanol.
The Policosanol Research confirms that policosanol is indicated as an adjunct to dietary and lifestyle recommendations to reduce elevated LDL-C and total cholesterol levels. Its primarily application is in type II hypercholesterolemia including IIa subtype (characterized by elevated total serum cholesterol and LDL-C levels) and IIb subtype (mixed hypercholesterolemia characterized by elevated total serum cholesterol, LDL-C andtriglyceride levels). Policosanol can also be used as an alternative to aspirin as an anti-platelet agent.
Policosanol is rapidly absorbed based on radioactive absorption studies in experimental animals (rats, rabbits and monkeys) and humans.1,2 Peak levels have been achieved from 30 to 120 min after treatment in different animal species and humans. Radioactivity is mainly distributed in the liver while radioactivity levels in the systemic circulation are low.
This effect is an advantage for a cholesterol-lowering agent since the liver is the main organ for synthesis and regulation of cholesterol metabolism. Excretion studies in animals and human healthy volunteers have demonstrated that feces is the main route for radioactivity excretion after oral administration, urinary excretion is not relevant.
The pharmacological effects of policosanol based on the policosanol research experimental models can be summarized as follows:
The Policosanol Research indicates that policosanol not only effectively decreases serum cholesterol levels,but also reduces the cholesterol content in different tissues such as liver, heart and fatty tissue.7
The cholesterol-lowering effects of policosanol are persistent and it does not lose its effect over time.
Policosanol is an agent to lower cholesterol with exceptional clinical documentation demonstrating efficacy, safety and tolerability in patients with type II hypercholesterolemia and in patients with secondary hypercholesterolemia associated to diabetes mellitus or nephrotic syndrome.
The policosanol research includes short and long-term, randomized, placebo-controlled and comparative studies versus statins (lovastatin, pravastatin and simvastatin), fibrates (bezafibrate and gemfibrozil), acipimox, and probucol involving nearly 3,000 subjects.
In these studies, policosanol in dosages ranging from 5 to 20 mg/day, has demonstrated significant improvements in LDL-C, total cholesterol, HDL-C, and the ratios of total cholesterol to HDL-C and LDL-C to HDL-C. Policosanol is shown to lower cholesterol within the first 6-8 weeks of use.
The recommended starting dose is 10-20 mg once a day with the evening meal, since cholesterol biosynthesis is increased at night.
An evening dosage is preferred because most cholesterol manufacture occurs at night. As with other cholesterol-lowering therapies, dosage may be adjusted periodically according to changes in blood cholesterol levels.
At a daily dosage of 20 mg, LDL levels typically drop by 25-30% during the first 8-12 weeks of therapy. HDL cholesterol levels typically increase by 15 to 25% after only two months of use. The combined LDL reduction and HDL increase can produce dramatic improvements in the LDL to HDL ratio.
Figure 1. Policosanol research indicates that the lipid-lowering effects of policosanol are dose-dependent (% changes compared to placebo in eight-week treatment periods).22
Policosanol Research indicates that these improvements in lipid profiles compare quite favorably to results observed with statin drugs. From comparative studies it can be concluded that 10 mg of policosanol is equivalent in efficacy to 20 mg of lovastatin, 10 mg pravastatin, and 10 mg of simvastatin.
But, while these drugs have well-known side effects, policosanol is completely safe.Policosanol has not been shown to produce any adverse drug interaction as well and it can be used in diabetics, elderly subjects, and even in patients with impaired liver function or severe liver damage without fear of side effect.
In addition to its effects on cholesterol levels, policosanol also exerts additional positive effects in the battle against atherosclerosis.
It prevents excessive platelet aggregation without effecting coagulation, prevents smooth muscle cell proliferation into the intima of the artery, and exerts good antioxidant effects in preventing against LDL oxidation.
Figure 2. The efficacy of 10 mg of policosanol daily is maintained in long-term therapy (comparison vs. placebo).29
In 1997 Policosanol research compared statin drugs lovastatin (Mevacor), simvastatin (Zocor) and pravastatin (Pravachol) with policosanol.
Footnote. Since that time new statin drugs have come to the market. Atorvastatin (Lipitor), rosuvastatin (Crestor) and a combination drug called Vytorin which consists of simvastatin (Zocor) and eztimibe. Although comparison studies have not been conducted on these newer statin drugs they are similar in function to their predecessors.
Policosanol administered for eight weeks at 10 mg day has shown a similar efficacy to lovastatin administered at 20 mg/day.31,32Both drugs produced similar decreases in LDL-C levels, while lovastatin was slightly more effective than policosanol in reducing total cholesterol. However, the reason is thatpolicosanol, but not lovastatin, significantly increased HDL-C levels in these studies.
Policosanol raised HDL levels by over 17% from baseline values while lovastatin actually decreased HDL-C levels slightly.
Another advantage for policosanol is that it has no hepatotoxic effect. Lovastatin significantly, but moderately, increased serum transaminases and creatine phosphokinase values while policosanol did not. Other side effects were also noted in lovastatin-treated patients but not in policosanol.
While pravastatin produced a significant increase the serum levels of alanine and aspartate aminotransferase (ALT and AST, respectively), policosanol exhibited no hepatotoxicity.
In patients with type-II hypercholesterolemia and concomitant NIDDM, policosanol, but not Simvastatin, significantly increased HDL-C levels.35 Again, more adverse experiences were and have been reported in simvastatin treated patients than in policosanol treated patients.
A comparative double blind clinical trial versus acipimox for eight weeks in type II hypercholesterolemic patients has shown that policosanol is more effective than acipimox in reducing LDL-C and total cholesterol.39
In addition, serum Lp(a) levels were significantly reduced by policosanol treatment both in the whole study population (32.6 % reduction) as well as in the stratum showing initial high Lp(a) levels (> 30 mg/dl) (57.4 % reduction).
Lp(a) is a plasma lipoprotein with a structure and composition that closely resembles LDL, but with an additional molecule of an adhesive protein called apolipoprotein (a).
Elevated plasma levels of Lp(a) are an independent risk factor for coronary heart disease, particularly in patients with elevated LDL cholesterol levels.
A high level of Lp(a) has been shown to carry a ten times greater risk for heart disease than an elevated LDL cholesterol level. That is because LDL on its own lacks the adhesive apolipoprotein (a). As a result, LDL does not easily stick to the walls of the artery. Levels of Lp(a) below 20 mg/dl are associated with a low risk for heart disease; levels between 20 and 40 mg/dl a moderate risk; and levels above 40 mg/dl an extremely high risk for heart disease.
Policosanol Research in Diabetics
Policosanol administered to non-insulin dependent diabetes mellitus (NIDDM) patients with type-II hypercholesterolemia significantly lowered LDL-C, serum total cholesterol and atherogenic ratios, while increasing HDL-C levels.
In addition, policosanol does not impair glycemic control in diabetic patients as assessed through the evaluation of its effects on blood glucose and glycosylated hemoglobin (HgbA1c) values.41,42
|Table 2. Effect of policosanol on serum lipid profile of patients with NIDDM.41|
|Treatment||Baseline||12 weeks||Percent change|
|Total cholesterol (mmol/L)|
|Total cholesterol to HDL-C|
|LDL-C to HDL-C|
Policosanol significantly reduced LDL-C (-19.1%), total cholesterol (-13%) and the ratios of cholesterol to HDL-C (-20%) and LDL-C to HDL-C (-24.2%) in hypertensive patients with hypercholesterolemia, while significantly increasing HDL-C levels (+17.1%).43
After 12 months of therapy policosanol significantly lowered systolic pressure (-10 mm Hg), while in the placebo group the values remained unchanged.
Many of the patients were on beta-blockers and diuretics, two classes of drugs known to adversely impact blood lipid levels.
Policosanol administered for short or long-term in patients over the age of 60 years with hypercholesterolemia has been effective, safe and well tolerated.44,45
In this population policosanol has a similar efficacy profile to that observed in patients below 60 years old. Table 3 summarizes the main results obtained at months 6 and 12 in a long-term study performed in elderly patients.
Of particular importance in this population is the fact thatno drug-related adverse experiences have been shown.
Elderly patients are at risk for such problems due to impaired renal and hepatic clearance as well as a high coexistence of concomitant diseases and of medications consumption are present.
|Table 3. Effect of policosanol on the serum lipid profile in elderly patients with hypercholesterolemia|
|Treatment||Baseline||6 months||12 months||Percent change|
|Total cholesterol (mmol/L)|
The efficacy pattern of policosanol in patients with type II hypercholesterolemia and concomitant disturbances of hepatic function is similar to that shown in hypercholesterolemic patients without impairment of liver function.46
Policosanol reduced total cholesterol (-13.6%), LDL-C (-19.1%), LDL-C to HDL-C ratio (-25.5%) and raised HDL-C (+11.5%).
In addition, policosanol was shown to reduce levels of alanine aminotransferase (ALT) and gamma-glutamyltranspeptidase (GGT) toward normal values.
Policosanol reduced effectively total cholesterol, LDL-C and triglycerides values while increasing HDL-C levels in patients with the nephrotic syndrome without adversely affecting renal function.47
Policosanol reduces platelet aggregation by altering prostaglandin synthesis. Specifically, policosanol lowers serum levels of the pro-aggregatory thromboxane A2, while increasing the anti-aggregatory prostaglandin prostacyclin.
Clinical trials in humans have shown that policosanol significantly inhibits platelet aggregation without affecting coagulation parameters.9-11 Policosanol's effects on platelet aggregation compare quite favorably to low-dose aspirin.48
|Table 5. Effects of policosanol (10 mg/day) or placebo on platelet aggregation in 30 healthy volunteers|
|Arachidonic acid 0.5 M|
|Epinephrine 1.25 x 10-5 M|
|Collagen 0.5 mcg/ml|
|ADP 2 x 10-6 M|
Policosanol was shown to improve the clinical evolution, and exercise-ECG testing responses of coronary heart disease (CHD) patients with myocardial ischemia, documented by exercise myocardial perfusion scintigraphy.49 In the double-blind study, 15 patients were treated with 5 mg of policosanol twice daily; another 15 patients were administered the same dose plus 125 mg aspirin; and the other 15 patients received placebo plus equal aspirin dose.
They were followed for 20 months, previous baseline observations, with treadmill exercise-ECG, besides serum lipid test. Beneficial changes on proportions among the 2 policosanol groups and the placebo group, showed an increment on functional capacity class, a decrement on rest and exercise angina, and a significant decrease in cardiac events, and in ischemic ST segment response, especially in the policosanol plus aspirin group.
Policosanol exhibits an exemplary safety profile. In all controlled studies, policosanol has exerted no negative effect of any clinical or laboratory parameter. Side effects were comparable to a placebo.
The withdrawal rate for policosanol in short and long-term clinical studies was comparable or even lesser than that of placebo; only 0.2 % policosanol-patients withdrew before conclusion of the study as a result of an adverse experience, compared with 0.6 % of placebo patients. Comparative studies have shown a dropout rate due to side effects of 0.9% in policosanol-treated patients compared with a 4.4% rate for those treated with other lipid-lowering drugs (e.g., statins, fibrates, probucol, and acipimox).
In a large post marketing policosanol research surveillance study, the tolerability of policosanol was assessed in 27,879 patients (17,225 patients for two years and 10,654 patients for four years). All of the patients were treated for at least one month. During the study, 86 patients (0.31%) reported adverse effects, the most frequent of which was weight loss.
A single dose (1,000 mg/day) as much as 50 times the maximum recommended dose (20 mg/day) administered to healthy volunteers produced no adverse reaction, hence no over dosage symptoms have been detected.
Animal policosanol research studies demonstrate the policosanol is virtually non-toxic as the oral LD50 in rats, mice, rabbits and dogs was > 5 000 mg/kg. Body weight gain, behavioral assays, as well as biochemical and hematological determinations in surviving animals at the end of the test (14 days) did not reveal differences between treated and control groups. Moreover, weight organ analysis and histopathological study did not reveal differences between groups.51,52
The effects of successive dosage increases of policosanol administered orally to Macaca arctoides monkeys demonstrated that even the highest dose administered (500 mg/kg) Policosanol was tolerated. Similar results have been shown oral subchronic and chronic toxicity models in rats, dogs, and monkeys.53-55Policosanol did not produce any adverse effects on fertility and reproduction in animal studies, nor has it exerted any mutagenic or carcinogenic effects.56-60 Specifically, policosanol administered orally up to 500 and 1000 mg/kg during the organogenesis period did not produce embryotoxic nor teratogenic effects in rats or rabbits and a multigenerational study did not shown any toxicity.
Although policosanol neither induced teratogenic effects in rats or rabbits nor affected rat fertility and reproduction, the treatment is not allowed to use in pregnant women. The reason for this restriction is that cholesterol and associated metabolic products are required for an adequate fetal development. Since hypercholesterolemia and atherosclerosis are chronic diseases, the suspension of lipid-lowering therapy for 9 months cannot be considered as an additional coronary risk factor.
Lactation - It is not known whether the product or some active metabolite is excreted via the human milk during nursing, therefore therapy should be discontinued during lactation.
Pediatric use - Efficacy and safety of policosanol in children has not been well established. Thus, treatment of children with policosanol is not recommended at the present.
The policosanol research has demonstrated synergism with the anti-platelet properties of aspirin in experimental animal models and healthy human volunteers as well as in different experimental animal models of ischemia and thrombosis.Pretreatment with policosanol inhibited aspirin-induced gastric ulcer in experimental animals.
Single or repeated doses of policosanol administered orally did not significantly affect fibrinolytic activity or bleeding time in rats. In these studies interaction between policosanol and heparin or warfarin have been ruled out.61
Antipyrine is a model drug used to investigate interaction with drugs metabolized by liver microsomal enzymes (the P-450 system). Policosanol administered orally to Beagle dogs for 3 to 4 weeks did not affect antipyrine or theophylline pharmacokinetics, suggesting that it does not interact with drugs metabolizing processes involving the P-450 microsomal system.
Although no specific policosanol research has been developed to evaluate its possible pharmacological interactions, in short and long-term clinical studies policosanol has been simultaneously employed each of the following drugs without evidence of clinically relevant adverse interactions.
Although the tolerability profile remains excellent increasing the dose to 40 mg/day does not offer significant additional cholesterol-lowering benefits over the 20 mg/day dose.
Policosanol is a mixture of fatty alcohols derived from the wax of sugar cane. These active substances work to lower cholesterol levels by several mechanisms. It inhibits cholesterol manufacturer but does so prior to HMG-CoA reductase. In addition policosanol also exerts exceptional effects on LDL-cholesterol metabolism.
Specifically, policosanol increases LDL receptor processing.It exerts this effect by increasing the binding of LDL to its receptor, improving the transport of LDL into the liver cell, and significantly enhancing the breakdown of LDL cholesterol.
In addition to lowering LDL, policosanol has also been shown to increase HDL, protect against free radical damage to LDL-cholesterol, and inhibit excessive platelet aggregation.
All together, policosanol exerts many pharmacological actions of benefit in the prevention and treatment of atherosclerosis or hardening of the arteries. The clinical documentation for policosanol is exceptional.
Well designed policosanol research studies trials have included short and long-term, randomized, double-blind studies comparing policosanol to a placebo as well as double-blind comparative trials versus statin drugs, fibrates, acipimox, and probucol.
Policosanol produces cholesterol-lowering effects within the first 6-8 weeks of use. At a daily dosage of 10-20 mg of policosanol at night, LDL cholesterol levels typically drop by 20 to 25% within the first six months of therapy.
At a dosage of 20 mg, LDL levels typically drop by 25-30%.
HDL cholesterol levels typically increase by 15 to 25% after only two months of use.
The combined LDL reduction and HDL increase can produce dramatic improvements in the LDL to HDL ratio.
Policosanol is completely safe.
Policosanol has not been shown to produce any drug interaction when used a wide range of concomitant therapies and has been used effectively in the following populations:
Policosanol is not only virtually side effect free it also has a number of health benefits, but the most powerful is its ability to increase your good cholesterol, which is more important than lowering your so called "bad" cholesterol.
Most statin drugs do NOT improve HDLs. HDL cholesterol levels typically increase by 15 to 25% after only two months of policosanol use.
The "good" HDL cholesterol is the "Superman" heart protector. HDL cholesterol acts like a miniature hydraulic vacuum cleaner, streaming through your arteries scooping up the heart- stopping LDL cholesterol, and carrying it back to your liver where it can be sent packing.
The benefits of policosanol are well documented by studies of nearly 30,000 persons. It comes with recommendations from recognized authorities such as Dr. Michael Murray. Unlike statin drugs such as Lipitor, Crestor and Zocor, side effects are rare and minimal.I'm Gene Millen a Heart Health Coach and the co-owner of this website with my wife Bernie.
During the last 23 years I have worked with hundreds of people who are looking for ways to lower their cholesterol without the use of statin drugs.
I've invested untold hours studying the research to discover the best ways to keep my heart and (and yours) healthy.
It was nearly 13 years ago that I first discovered Policosanol. I've found Policosanol to be one of the best alternatives to Lipitor and other statin drugs as it lowers ldl cholesterol and increases the good hdl cholesterol...and without the side effects caused by statin drugs.
"When the results of my cholesterol lab test came back in the spring of 2001, my triglycerides were sky high (1723) and my HDL cholesterol so low (8) that I was frightened enough to try any solution the doctor suggested.
"He prescribed a low-fat, low-carbohydrate diet, exercise and high doses of niacin. This brought the triglycerides down to a reasonable level; however, nothing seemed to budge the low HDL level to much above 18.
"When we moved out of state, my new doctor insisted that I try a combination of niacin and a statin drug to address what he thought were "unacceptable" numbers.
In 2010 I finally caved and agreed to the statin combination of niacin and a statin drug.
Within a year I was unable to walk up and down stairs and couldn't lift myself from a sitting position without holding on to something.
"I immediately stopped the statin/niacin (against the doctor's advice), and I began in earnest scouring the internet for alternative solutions to what for me had been harmful pharmaceutical drugs.
"How fortunate for me that I found the Millen's Vital Heart Health for Life site. I ordered policosanol and within six months my HDL began improving.
My last test, three months ago showed my HDL at 36, not ideal I realize, but for me the best it has ever been. Triglycerides and LDL were also within normal range, and my total cholesterol was 180.
"I am so very thankful that Gene and Bernie Millen continue to offer what I consider life-saving advice, and products such as policosanol, for those of us who are desperately searching for alternatives to the "traditional" drugs prescribed by most physicians today.
Janelle Carey, Savoy, Illinois
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