Cholesterol Showdown

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.


*Do you boxing fans remember the phenomenal Cuban heavyweight Teofilo Stevenson? What amazing grace, elegance, and power! He could be a symbol for policosanol.


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.


*The cost of one month’s supply of atorvastatin (10 mg/day) is about $100. The cost of one month’s supply of policosanol (10–20 mg/day) is about $15–30.


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.”1 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.2 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.3

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.1 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).2

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.

  1. Janikula M. Policosanol: a new treatment for cardiovascular disease? Alt Med Rev 2002;7(3):203-17.
  2. 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.

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.4 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.4


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%

In every case except HDL-cholesterol, lower levels are better; note that the differences between policosanol’s and atorvastatin’s effects tended to narrow over time. For HDL-cholesterol, higher levels are better; note that policosanol’s initial superiority expanded over time.

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

  1. Gaist D et al. Statins and the risk of polyneuropathy. Neurology 2002;58(9):1333-7.
  2. 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.
  3. 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.
  4. 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.



Dr. Rosick is an attending physician and clinical assistant professor of medicine at Pennsylvania State University, where he specializes in preventive and alternative medicine. He also holds a master’s degree in healthcare administration.

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