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Policosanol Is a Champion in the Making
Cholesterol Showdown: Policosanol vs. Atorvastatin
Natural supplement scores big points over statin drug on
safety and HDL levels By Dr. Edward R. Rosick
adies and gentlemen, let’s get ready to
rrrumble! Tonight we
invite you to witness a heavyweight match between the two leading
anticholesterol agents. In the red corner, representing the pharmaceutical
industry (please, hold your boos), is the currently top-ranked fighter,
Atorvastatin. He’s a big bruiser with some good moves, but he has a few
weaknesses that the challenger might exploit. In the blue corner, representing
the natural supplements industry (cheering is allowed), is the top-ranked
contender, Policosanol. He’s tall, lean, and muscular, with precision punches
of surprising power, considering that he comes from a refined background of . .
. Cuban sugar cane?* We’ll get to that, but first, some background.
Looking for a Champion Cholesterol Fighter
Pharmaceutical companies have poured billions of dollars into
their search for drugs to combat high cholesterol levels. The primary target is
LDL-cholesterol (low-density lipoprotein cholesterol, or LDL for short), also
known as “bad cholesterol.” High levels of LDL are a major risk factor for
atherosclerosis and heart disease. The buildup of cholesterol-containing plaque
inside our arteries obstructs blood flow to vital organs, such as the heart,
the brain, and the genitals—for which the most serious consequences are heart
attack, stroke, and impotence, respectively. Two of these can be fatal (and the
third might as well be, in the view of some of its victims). A chemical
agent—whether synthetic drug or natural supplement—that could reduce LDL levels
could potentially slow or stop the progression of atherosclerosis and its
terrible consequences.
Atorvastatin, the #1 Contender from the Drug Laboratory
Many doctors believe they have found the best remedy for
high cholesterol, in the form of prescription drugs called statins. There are
five currently in use—atorvastatin, fluvastatin, lovastatin, pravastatin, and
simvastatin—and they’re among the top-selling drugs in the United
States. Comparative studies have shown that
atorvastatin is by far the most effective of the five statins in reducing LDL
levels, which is why it’s now in the ring with policosanol (be patient, the
fight will begin soon). Although there have been no direct studies on
atorvastatin’s ability to reduce heart disease, it seems reasonable to think
that, since other statin drugs are known to decrease the incidence of heart
disease, atorvastatin should be at least as effective, and probably more so.
Statins Can Cause Liver Damage
The statins are widely prescribed, but they’re not without
significant costs, from both monetary and health standpoints. Atorvastatin and
its pharmacological kin are quite expensive, for one thing.* As the old saying
goes, however, money isn’t everything, and with atorvastatin, the potential
health costs can be even higher. Although the statins are quite safe, as
synthetic drugs go, they can cause abnormalities in liver function. In fact,
statin drugs are contraindicated in patients with known liver disease or in the
elderly who have liver problems, even if the patient has high LDL levels.
Another side effect that has occasionally been seen with
statin drugs is polyneuropathy, a condition in which proper functioning of the
body’s peripheral nerves is impaired, leading to numbness and weakness in the
extremities. A recent case-control study in Denmark concluded that “long-term
exposure to statins may substantially increase the risk of polyneuropathy.”
Atorvastatin and other statins can also cause myopathy (a weakness or wasting
of the muscles), including rhabdomyolysis, a severe form of myopathy that can
be fatal. The statin drug cerivastatin was withdrawn from the market in 2001
owing to an unusually high incidence of this condition.
Policosanol, a Natural-Born Cholesterol Fighter
Squared off against atorvastatin in the boxing ring is our
favorite, the natural supplement policosanol, a mixture of eight closely
related compounds that are derived from sugar cane (but they are not sugars, so
they do not raise blood sugar levels). Policosanol was developed in Cuba in the
1990s, and most of the research on this substance has been done by Cuban
scientists, who have documented its remarkable safety and efficacy in numerous
clinical trials.
In some of these studies, policosanol was compared directly
with some of the older statin drugs, and in all of them, it was found that
policosanol was as effective or more effective than these drugs in lowering LDL
levels. Moreover, policosanol was shown to be extremely safe, displaying none
of the liver toxicity that the statin drugs sometimes show (see the sidebar).
With its proven LDL-lowering ability, it’s no wonder that policosanol, like the
statins, has been shown to reduce the risk of heart disease in people with high
levels of LDL.
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Policosanol Causes No Liver Damage
Policosanol is so safe that it can be readily tolerated in
amounts much greater than those actually used in humans. There is a
conspicuous lack of side effects—including the liver damage that can sometimes
occur with statin drugs. A recent study suggests that policosanol may even have
a protective effect against chemically induced liver damage, at least in rats
(it’s hard to get humans to volunteer for that sort of thing).
It must be noted, however, that the two dosages of
policosanol used in this study were enormous: 25 and 100 mg per kg of body
weight. For a human being weighing 70 kg (154 lb), those amounts would
correspond to 1750 and 7000 mg, respectively. By contrast, the daily amounts
actually used in human trials of policosanol have typically been in the range
of 10–20 mg.
Thus these rat results are interesting, but far removed from
relevance to humans. Perhaps more significant than the fact that policosanol
provided some protection against liver damage in the rats is that these huge
doses did not cause any liver damage. This is consistent with the lack of any
liver damage from policosanol in clinical studies on humans.
- Janikula M.
Policosanol: a new treatment for cardiovascular disease? Alt Med Rev
2002;7(3):203-17.
- Noa M, Mendoza S, Mas R, Mendoza N. Effect of
policosanol on carbon tetrachloride-induced acute liver damage in
Sprague-Dawley rats. Drugs R&D 2003;4(1):29-35.
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Policosanol and Atorvastatin Go Toe-to-Toe
With two such powerful cholesterol fighters as policosanol
and atorvastatin making waves in medical circles, it was inevitable that they
would eventually go toe-to-toe in clinical trials to see if a champion could be
crowned. The first such study has been published; it was a randomized,
single-blind study done with 75 patients, 60–80 years old, who had high levels
of LDL-cholesterol. After 4 weeks on a cholesterol-lowering diet, the patients
were divided into two groups, with one group receiving 10 mg/day of policosanol
and the other group receiving 10 mg/day of atorvastatin, for 8 weeks. The
researchers checked the patients’ blood levels of cholesterol and triglycerides
(fats) at the outset of the trial and again after 4 weeks and 8 weeks (see
Table 1).
Table 1. Effects of policosanol (10 mg/day) and atorvastatin
(10 mg/day) on the lipid profile of 75 patients with high cholesterol.
|
Week 4
|
Difference
|
Week 8
|
Difference
|
|
LDL-Cholesterol
|
|
|
|
| Policosanol |
–17.5% |
|
–23.1% |
|
| Atorvastatin |
–28.4% |
10.9% |
–29.8% |
6.7% |
|
HDL-Cholesterol
|
|
|
|
| Policosanol |
+2.8% |
|
+5.3% |
|
| Atorvastatin |
–3.3% |
6.1% |
–1.9% |
7.2% |
|
Total Cholesterol
|
|
|
| Policosanol |
–12.5% |
|
–16.4% |
|
| Atorvastatin |
–21.1% |
8.6% |
–22.6% |
6.2% |
|
Triglycerides
|
|
|
| Policosanol |
–6.9% |
|
–15.4% |
|
| Atorvastatin |
–6.9% |
0% |
–15.5% |
0.1% |
|
LDL/HDL ratio
|
|
|
| Policosanol |
–17.5% |
|
–25.5% |
|
| Atorvastatin |
–25.0% |
7.5% |
–26.2% |
0.7% |
|
Total Cholesterol/HDL ratio
|
|
|
| Policosanol |
–12.9% |
|
–19.3% |
|
| Atorvastatin |
–17.6% |
4.7% |
–19.8% |
0.5% |
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Policosanol Scores Points on Safety
In the match between policosanol and atorvastatin, the
plucky Latin American cholesterol fighter scored some early points on the
judges’ (researchers’) scorecards when it came to safety. While three patients
taking atorvastatin withdrew from the study owing to adverse effects such as
muscle aches, cramps, gastritis, and abdominal pain, along with uncontrolled
high blood pressure, not one patient taking policosanol reported any adverse
effects. Atorvastatin also caused an increase in the blood levels of creatinine
and CPK (markers of muscle activity or irritation). By contrast, policosanol
actually reduced CPK levels, along with AST levels (a marker of liver activity
or irritation).
Atorvastatin Comes Back with LDL Reduction
After policosanol took an early lead with its excellent
safety profile, atorvastatin made up lost ground with its superior effect on
LDL levels. At 4 weeks, atorvastatin reduced LDL by 28.4% vs. policosanol’s
17.5% (a difference of 10.9%, but both of these figures are impressive by any
standard). At 8 weeks, the decreases were 29.8% and 23.1%, respectively (a
difference of 6.7%). It’s interesting that the gap between the two values
narrowed considerably between the 4-week and 8-week time points, as
policosanol’s effect grew substantially larger. One wonders whether this gap
might have narrowed further had the trial gone on for a longer period.
Policosanol Rallies with HDL Increase
With atorvastatin having such a powerful punch against LDL,
you might think that it would be a clear winner against policosanol. But,
barring a knockout, a fight is never over until the last round. In this case,
policosanol staged a late-round rally with its impressive ability to increase
HDL-cholesterol (high-density lipoprotein cholesterol, or HDL for short), also
known as “good cholesterol.” This is the one measure of cholesterol that we
want to have higher, not lower, because higher HDL levels are associated with a
decreased risk of heart disease.
In this case, as the data in Table 1 show, policosanol was
clearly superior to atorvastatin at the 4-week time point, and the gap between
the two values widened with time, which is all the better. As the researchers
put it, “At 8 weeks, policosanol was significantly more effective than
atorvastatin in increasing serum HDL-C levels from baseline . . . which reveals
that policosanol induced beneficial effects on HDL-C levels not found with
atorvastatin.”
And the Winner Is . . .
Usually in boxing, there’s a clear winner, but sometimes
there’s a split decision, or even a draw. After reviewing the evidence and
looking at the judges’ scorecards, it appears that this first match between
policosanol and atorvastatin could be called a draw. Although atorvastatin held
the edge in reducing LDL levels (for 8 weeks, anyway), policosanol scored big
points with its safety profile as well as its strong ability to increase HDL
levels. Until these two cholesterol fighters are pitted against each other in
more rigorously controlled studies, it seems like a good bet to put your money,
and ultimately your health, on the safe and natural cholesterol-fighting
abilities of policosanol.
References
- Gaist D et
al. Statins and the risk of polyneuropathy. Neurology 2002;58(9):1333-7.
- Gouni-Berthold
I, Berthold HK. Policosanol: clinical pharmacology and therapeutic significance
of a new lipid-lowering agent. Am Heart J 2002;143(2);356-65.
- Castano G,
Fernandez L, Mas R, et al. Comparison of the efficacy, safety, and tolerability
of original policosanol versus other mixtures of higher aliphatic primary
alcohols in patients with type II hypercholesterolemia. Int J Clin Pharm Res
2002;22(2):55-66.
- Castano G, Mas R, Fernandez L, et al. Comparison
of the efficacy and tolerability of policosanol with atorvastatin in elderly
patients with type II hypercholesterolaemia. Drugs Aging 2003;20(2):153-63.
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