By Gene Millen, Wellness Coach - Revised March 13, 2013
The Policosanol Research includes well designed clinical trials
involving nearly 30,000 patients.
long term randomized double-blind studies comparing policosanol to a
placebo as well as...
comparative trials versus statin drugs, fibrates, niacin and probucol.
results from the policosanol research studies clearly demonstrate that policosanol
is overall the absolute best answer to high cholesterol levels whether
we are talking about a nutritional supplement, herbal product, or
POLICOSANOL RESEARCH DESCRIPTION
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 and triglyceride levels). Policosanol can also be used as an
to aspirin as an anti-platelet agent.
The recommended starting dose is 10-20 mg once a day with the evening
meal, since cholesterol biosynthesis is increased at night.
POLICOSANOL RESEARCH: PHARMACOKINETICS
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:
Policosanol produces a dose-dependent and significant reduction of
serum total cholesterol and LDL-C levels. HDL-C values were also increased
in a dose-dependent manner. Triglycerides are also significantly reduced,
but the reduction is not dose-dependent.3,4,
- Policosanol Research shows policosanol lowers total cholesterol and LDL-C by:
- Inhibiting cholesterol synthesis at a point between the formation
of acetate and mevalonate.5,6
- Exerting no direct inhibition on HMG-CoA reductase.5,6
- Significantly increasing LDL receptor dependent processing as
demonstrated by increasing the incorporation of LDL into the hepatocyte
and stimulating its catabolism.5,6
- 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 reduces platelet aggregation by altering prostaglandin
synthesis. Specifically, policosanol lowers serum levels of the pro-aggregatory
thromboxane A2, while increasing the anti-aggregatory prostaglandin
- Policosanol prevents and reverses atherosclerotic lesions and thrombosis.11-15
- Policosanol prevents intimal thickening and smooth muscle cell proferation.16,17
- Policosanol is an effective antioxidant in preventing LDL oxidation.18,19
SHOWN IN POLICOSANOL RESEARCH
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.
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.
recommended dosage of policosanol is 10-20 mg at the evening meal. It is
given at night 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.
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
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
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
DOUBLE-BLIND STUDIES VS. CHOLESTEROL-LOWERING
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
Policosanol administered for eight weeks at 10 mg day has shown a similar
efficacy to lovastatin administered at 20 mg/day.31,32 Both drugs produced
similar decreases in LDL-C levels, while lovastatin was slightly more
effective than policosanol in reducing total cholesterol. However, the
reason is that policosanol, 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
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.
Policosanol administered at 10 mg/day was compared with the same dosage
of pravastatin for eight weeks.33
The policosanol group demonstrated
greater percent changes of LDL-C and HDL-C than the pravastatin group.
Side effects were more frequent in the pravastatin group than in policosanol
Figure 3. The efficacy of policosanol vs. pravastatin in type II hypercholesterolemia.33
Policosanol Research of Simvastatin
Policosanol and Simvastatin were found to be equally effective at dosages
of 10 mg/day for eight weeks in patients with type-II hypercholesterolemia.34,35
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.
Policosanol Significantly Reduced
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
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.
DOUBLE-BLIND TRIALS IN SPECIAL POPULATIONS
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
|Total cholesterol (mmol/L)
| Triglycerides (mmol/L)
| Total cholesterol to HDL-C
| LDL-C to HDL-C
Policosanol Research in Hypertensive patients (high
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
significantly lowered systolic pressure (-10 mm Hg), while in the placebo
group the values remained unchanged.
Many of the patients were on
and diuretics, two classes of drugs known to adversely impact blood
Research in Elderly Patients
Policosanol administered for short or long-term in patients over the
age of 60 years with hypercholesterolemia has been effective, safe and
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.
|Table 3. Effect of policosanol on the serum lipid
profile in elderly patients with hypercholesterolemia
|Total cholesterol (mmol/L)
Patients with Type II Hypercholesterolemia and Disturbances of Hepatic
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 in the Nephrotic Syndrome
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 RESEARCH: ANTI-PLATELET EFFECTS
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
|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 RESEARCH SHOWS ANGINA IMPROVEMENT
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.
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 SIDE EFFECTS, SAFETY AND TOXICOLOGY
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.
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
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
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
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.53-55 Policosanol did not produce any adverse
effects on fertility and reproduction in animal studies, nor has it exerted
any mutagenic or carcinogenic effects.56-60
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.
It is not known whether the product or some active metabolite is excreted
via the human milk during nursing, therefore therapy should be discontinued
Efficacy and safety of policosanol in children has not been well established.
Thus, treatment of children with policosanol is not recommended at the
POLICOSANOL DRUG INTERACTIONS
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
Antipyrine and theophylline
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.
Other concomitant therapies
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
inhibitors of angiotensin-converting enzyme,
neuroleptics, oral hypoglycemic agents,
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.
SUMMARY OF POLICOSANOL RESEARCH
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.
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.
to lowering LDL, policosanol has also been shown to increase HDL, protect
against free radical damage to LDL-cholesterol, and inhibit excessive
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
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,
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
Important Benefit of Policosanol
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.
drugs do NOT improve HDLs. HDL cholesterol levels typically
increase by 15 to 25% after only two months of policosanol
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 â€œdealt withâ€.
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.
Pictured on the left is a 2012 photo of
Gene Millen and his wife and best friend Bernie, your hosts on this journey to a healthy heart and a vital long life.
Gene experienced a heart by pass surgery in 1990 which prompted
a change in his career from bank president to heart health coach.
Gene first heard about
policosanol he was skeptical because it seemed too good to be true. However,
after studying the above research he not only became convinced...he got excited. This is one of the best natural products that
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