POLICOSANOL – A NATURAL CHOLESTEROL NORMALIZING SUPPLEMENT

Policosanol is a unique natural product derived from sugar cane OR it can be derived from beeswax & rice bran. It has proved effective at reducing cholesterol levels and for many individuals may be a reasonable natural alternative to the commonly prescribed “statin-type” cholesterol-lowering drugs.

Heart attack and stroke have been associated with high levels of a type of cholesterol known as low-density lipoprotein (LDL) (?bad? cholesterol) and low levels of high-density lipoprotein (HDL) (?good? cholesterol). Reversing these trends can lower the risk for these and other artery-related diseases.

Policosanol is a supplement that can normalize cholesterol as well or better than drugs, without side effects.(1) Efficacy and safety have been proven in numerous clinical trials, and it has been used by millions of people in other countries. Policosanol can lower LDL cholesterol as much as 20% and raise protective HDL cholesterol by 10%. This compares favorably with cholesterol-lowering drugs which have the drawback of side effects such as liver dysfunction and muscle atrophy. Policosanol is free of these side effects.

Policosanol works by blocking the synthesis of cholesterol. It does not inhibit the HMG-CoA enzyme like the ‘statin? cholesterol-lowering drugs, but it may inhibit a different enzyme. Its exact mechanism is not known.

What makes policosanol exciting is that it has other actions against heart disease in addition to lowering cholesterol. Unlike the Statin drugs, policosanol helps stop the formation of artery lesions.(2) This was proven in studies on rabbits fed a diet designed to create high cholesterol:

In most policosanol-treated animals, atherosclerotic lesions were not present, and in others, thickness of fatty streaks had less foam cell layers than in controls.?(3)

One of policosanol’s important actions is to inhibit the oxidation of LDL.(4) Oxidized LDL is dangerous. It promotes the destruction of blood vessels by creating a chronic inflammatory response. Oxidized LDL can also provoke metalloproteinase enzymes.(5) These enzymes promote blood vessel destruction, partly by interfering with HDL’s protective effect. Studies show that rats treated with policosanol have fewer foam cells, reflecting less inflammatory response causing less blood vessel destruction.(6,7)

Another action of policosanol is to reduce the proliferation of cells in the lining of the arteries. Healthy arteries are lined with a smooth layer of cells so that blood can race through with no resistance. One of the features of diseased arteries is that this layer becomes thick and overgrown with cells.

As the artery narrows, blood flow slows down or is blocked completely. Policosanol was tested for its ability to stop the proliferation of these cells.(8) According to the results, policosanol’s ability to stop cell overgrowth ?is in agreement with the antiproliferative effects reported for other lipid-lowering drugs, such as most of the statins.?(9)

Policosanol also inhibits the formation of clots, and may work synergistically with aspirin in this respect. In a comparison of aspirin and policosanol, aspirin was better at reducing one type of platelet aggregation (clumping together of blood cells). But policosanol was better at inhibiting another type. Together, policosanol and aspirin worked better than either alone.(10,11) A related effect is that significant reductions in the level of thromboxane occur in humans after two weeks of policosanol.(12) Thromboxane is a blood vessel-constricting eicosanoid produced by platelets. (Note: eicosanoids are powerful chemicals created in cells that can do things like create fever to kill infections, make blood vessels in lungs expand so you can breathe, and reduce inflammation. The body could not function without eicosanoids. Problems arise when eicosanoid reactions are disrupted by drugs, disease, poor diet and other factors that interfere with their natural balance).

Dosage of Policosanol

The dosage recommended in the literature is 5mg to 20mg daily. Most positive results are seen with daily doses of 20mg. We suggest one 10mg capsule once daily if needed as a preventative and one capsule twice daily after meals for a diagnosed clinical problem. The literature further states that there is NO added benefit with dosages greater than 20mg per day.

NOTE: What we do in our office for those wishing to try this non-toxic approach to normalizing their cholesterol numbers is to first wean themselves off their ststin medication. Then, after a week or so, take one capsule (10mg) of PCOH-PLUS, Biotics Research brand of policosanol, twice daily (AM & PM) for one month, then only take one capsule daily thereafter. After a total of two to three months get a blood test on the following:

Cholesterol
HDL Cholesterol
LDL Cholesterol
Triglycerides and
Lipoprotein(a)
Homocysteine

Then we can compare these results of taking policosanol with the statin drug taken before.

ADVANTAGES:

COST: Policosanol is only $30.00 for 60 capsules which comes out to $15.00 per month.
SAFETY: Policosanol is non-toxic and safe.

Drug interactions

As for interfering with other heart medication, policosanol doesn’t appear to cause any problems. Adverse reactions do not occur with blood thinners or beta-blockers, except that policosanol may enhance the blood pressure-lowering effect of propranolol.(13) No direct studies have been done combining policosanol with other drugs. However, during clinical trials policosanol was given to people taking calcium antagonists, diuretics, vasodilators, NSAIDs, meprobamate, thyroid hormones, digoxin, anticoagulants, ulcer drugs, neuroleptics, antidepressants and anxiolytics (anti-anxiety drugs) without any problems.(14)

Highlights of clinical trials

Policosanol has undergone as many clinical trials as most drugs. In studies on people with high cholesterol at high risk of heart disease, policosanol lowered LDL cholesterol 20% in 6 to 12 weeks at 10 mg/day. Total cholesterol was reduced 15%, and HDL increased 7%-28%. Taking 20 mg/day reduced LDL about 28%, total cholesterol about 20%, and elevated HDL 7%-10%. Triglycerides sometimes don’t respond to policosanol.

The 10 mg dose has undergone long-term testing (2+ years), with no ill effects reported. The 20 mg dose (and higher) is still undergoing long-term trials. (Note: as in most trials of cholesterol-lowering drugs, policosanol was tested in conjunction with a low-cholesterol diet).

Policosanol holds its own against statin drugs. LDL and total cholesterol lowering is similar, with policosanol performing better on elevating HDL. In a side-by-side comparison study from Chile, for example, 10 mg of policosanol reduced LDL 24% compared with 22% for lovastatin (Mevacor) at 20 mg, and 15% for simvastatin (Zocor) at 10 mg. This is similar to findings in other studies.(15)

A combination of policosanol and gemfibrozil (Lopid) works better than either by itself, according to one study.(16) Another study combined policosanol with bezafibrate, a cholesterol- and fibrinogen-lowering drug. Policosanol dramatically enhanced the ability of bezafibrate to lower LDL and total cholesterol.

In a study involving over 3000 people taking policosanol, only 26 dropped out because of side effects. The side effect complained of most frequently was weight loss. (Average time in the study 2.5 years).

In short-term, placebo-controlled trials, complaints of side effects from the placebo exceeded those for policosanol in every category except abdominal pain (which was reported equally in both). Policosanol appears to have good side effects rather than bad ones. One of the noted side effects of the large study above was that people taking policosanol had significantly lower rates of hospitalizations in special care units. Serious coronary events were reduced in the people taking policosanol compared to placebo.

Policosanol is a natural supplement made from sugar cane. The main ingredient is octacosanol. Octacosanol is an alcohol found in the waxy film that plants have over their leaves and fruit. The leaves and rinds of citrus fruits contain octacosanol, and so does wheat germ oil. Caviar, which reportedly has health benefits, contains high amounts of octacosanol.

Octacosanol is a ?long chain fatty alcohol? (similar to cholesterol which is also an alcohol). Policosanol is a combination of octacosanol and several other long chain fatty alcohols – hence the name ?poli?-cosanol. Keeping octacosanol together with other naturally-occurring fatty alcohols makes it more stable. There is evidence that octacosanol also works better when it’s combined with other fatty alcohols.

Fatty alcohols are converted to fatty acids, and vice-versa. The beneficial fatty acids in fish, for example, are made from octacosanol and other long chain fatty alcohols. Fatty alcohols are required for the synthesis of myelin, the insulation around nerves, as well as other important bio-substances in the body.

Policosanol is very safe. When rats were given 1724 times what a human would take, no toxicity occurred.(17) Monkeys and dogs have also been given high doses of policosanol long-term without toxicity.(18) No cancer has ever resulted in rodents given large amounts for extended periods or time, nor does policosanol appear to interfere with drug metabolism (it doesn’t affect the liver’s cytochrome p450).

Exercise enhancement

In studies dating back to the 1960s, octacosanol has shown its ability to enhance endurance and oxygen utilization during exercise. Research shows that octacosanol is taken up by muscles.(19) It appears that muscles store octacosanol and convert it to an energy source. Energy mobilization and metabolism are enhanced by octacosanol. When octacosanol is first given, most of it goes to the liver, but after three days of treatment, it starts accumulating in muscle.(20)

In studies from Japan, octocasanol caused rats to be more active and exercise more. It also increased their endurance. When people with heart disease are given 10 mg/day of policosanol, aerobic capacity and oxygen uptake increase, and ischemia decreases. Improvement on treadmill exercise-ECG tests occurs after treatment with policosanol. These results in heart patients confirm studies in healthy people undergoing exercise programs who were also able to increase reaction time and strength with octacosanol.

Libido enhancement

Unlike cholesterol-lowering drugs that can induce impotency, policosanol may have a libido-enhancing effect. Studies in male rats show that policosanol increases sexual activity without increasing testosterone. The same results appear to be true for monkeys, but the studies are too few to be definitive. Unfortunately, very high amounts of policosanol had to be taken to get these effects. However, the bright side is that when policosanol is taken at recommended doses, it doesn’t interfere with a person’s sex life, which gives it an advantage over many cholesterol-lowering drugs.

Summary of Non-toxic Benefits of Policosanol:

1. Lowers & normalizes cholesterol without ?life-threatening? side effects

2. Significantly elevates HDL while the Statin drugs have little or no effect

3. Inhibits the formation of harmful lesions in arteries while the Statins are not nearly as effective

4. Powerfully prevents oxidation of LDL cholesterol which causes atherosclerosis

5. Enhances the benefits of exercise – the Statins make most people tired

6. Reduces artery complications in people with artery diseases, i.e. prevents harmful changes in blood vessels in those with coronary heart disease (The Statins do not)

7. Produces a 45% improvement in clinical coronary heart disease patients

8. Dramatically reduces damage to the heart following a heart attack

9. Reduces thromboxane A2 which promotes inflammation & atherosclerosis

10. Safe for liver; will not elevate the liver enzymes & has been shown to protect the liver from powerful toxins

11. Substantially reduces the extent of brain injury if you have a stroke

12. Lowers fibrinogen levels that can cause the blood to bee too thick

13. Lowers glucose levels (Statins can increase blood glucose)

14. Shown to lower blood pressure in hypertensive people (Statins have no effect)

15. Does not interfere with sex life like the Statin drugs can

16. Does not deplete the heart-dependent CoEnzyme Q like Statins do

17. Reduces Lipoprotein(a) in most people [Lp(a) levels above 10 shows that the arteries are hardening]

18. Reduces the inflammatory hormone-like substance called Prostaglandin (PGE-2 – the bad prostaglandin)

19. Has been shown to improve exercise tolerance; specifically, improves treadmill exercise-ECG testing performance of coronary heart disease patients

20. It seems to work extremely well in patients over the age of 60 because the 60-year old liver has a harder time detoxifying the statin drugs than a younger aged liver

21. Extensive testing shows no carcinogenic effect (does not cause cancer) while the statin drugs have been shown to cause cancer

Other conditions respond to Policosanol

Policosanol has been tested in postmenopausal women at risk for heart disease, people over 60 years old, and people with intermittent claudication (blockage of arteries, usually in the lower extremities). All showed good results. In studies on postmenopausal women, policosanol (10 mg/day) reportedly reduced total cholesterol by 17% and LDL by 25%. HDL increased 28%. These results are similar to those reported in people over 60 who took 10 mg/day of policosanol. In studies on people with intermittent claudication, policosanol (20 mg/day) reduced lameness and increased the distance a person could walk. The percentage of serious complications in the policosanol group was 9.7% compared to 38.7% in the group getting a placebo. This significant reduction in intermittent claudiction-induced complications indicates that policosanol exerted beneficial effects beyond cholesterol modulation.(21)

Some studies show that cholesterol levels should be kept below 200 mg per deciliter of blood. Cholesterol levels above 240 may be dangerous. The dosage for policosanol is 5-20 mg/day. It can be taken with other drugs, and seems to enhance the effects of statin drugs, especially in conjunction with aspirin. No serious side effects have ever been reported for this cholesterol modifying supplement. Although it shows benefits for cholesterol, LDL and HDL, policosanol doesn’t appear to affect triglycerides. Serum triglyceride levels may be lowered by other supplements such as fish oil. One of the very striking benefits of policosanol is that it not only lowers LDL, it keeps it from oxidizing. This and other actions of this natural product give it potential as the number-one choice for people with artery disease?or those who want to prevent it.(22-23)

In a study conducted by R. Mas, et al., not only was cholesterol reduced in patients with additional coronary risk factors but it was noted that in some trials that triglycerides were also lowered by an average of 5.2%, which they concluded that policosanol is safe, effective & well tolerated in patients with high cholesterol & concomitant coronary risk factors.

References:
1. Mas R, et al. 1999. Effects of policosanol in patients with type II hypercholetserolemia and additional coronary risk factors. Clin Pharmacol Ther 65:439-47.

2. Noa M, et al. 1995. Effect of policosanol on lipofundin-induced atherosclerotic lesions in rats. J Pharm Pharmacol 47:289-91.

3. Arruzazabala ML, et al. 2000. Protective effect of policosanol on atherosclerotic lesions in rabbits with exogenous hypercholesterolemia. Braz J Med Biol Res 33:835-40.

4. Menendez R, et al. 1999. Oral administration of policosanol inhibits in vitro copper ion-induced rat lipoprotein peroxidation. Physiol Behav 67:1-7.

5. Xu XP, et al. 1999. Oxidized low-density lipoprotein regulates matrix metalloproteinase-9 and its tissue inhibitor in human monocyte-derive macrophages. Circulation 99:993-8.

6. Noa M, et al. 1996. Effect of policosanol on foam-cell formation in carrageenan-induced granulomas in rats. J Pharm Pharmacol 48:282-5.

7. Lindstedt L, et al. 1999. matrix metalloproteinases-3, -7, and -12, but not -9, reduce high density lipoprotein-induced cholesterol efflux from human macrophage foam cells by truncation of carboxyl terminus of apolipoprotein A-I. Parallel losses of pre-beta particles and the high affinity component of efflux. J Biol Chem 274:22627-34.

8. Noa M, et al. 1998. Effect of olicosanol on damaged arterial wall induced by forceps in rabbits. J Electron Microsc 4:629-30.

9. Negre-Aminou P, et al. 1996. Antiproliferative potencies of 6 vastatins in cultured human cells: involvement of the ras-mediated signalling pathway. 66th Cong Eur Atheroscler Soc (July 13-17, Florence): 120.

10. Arruzazabala ML, et al. 1997. Comparative study of policosanol, aspirin and the combination therapy policosanol-aspirin on platelet aggregation in healthy volunteers. Pharmacol Res 36:293-7.

11. Stusser R, et al. 1998. Long-term therapy with policosanol improves treadmill exercise-ECG testing performance of coronary heart disease patients. Int J Clin Pharmacol Ther 36:469-73.

12. Carbajal D, et al. 1998. Effect of policosanol on platelet aggregation and serum levels of arachidonic acid metabolites in healthy volunteers. Prost Leuk Essen Fatty Acids 58:61-4.

13. Molina V, et al. 1998. Effect of policosanol on arterial blood pressure in rats. Study of the pharmacological interaction with nifedipine and propranolol. Arch Med Res 29:21-4.

14. Carbajal D. 1998. Interaction policosanol-warfarin on bleeding time and thrombosis in rats. Pharmacol Res 38:89-91.

15. Prat H, et al. 1999. [Comparative effects of policosanol and two HMG-CoA reductase inhibitors on type II hypercholesterolemia]. Published in Spanish. Rev Med Chile 127:286-94.

16. Casta?o G, et al. 1998. Comparative study of policosanol, gemfibrozil and policosanol-gemfibrozil combination therapy in the treatment of type II hypercholesterolemia. Rev CENIC Cien Biol 29:17-23.

17. Aleman CL, et al. 1994. A 12-month study of policosanol oral toxicity in Sprague Dawley rats. Toxicol Lett 70:77-87.

18. Rodriguez-echenique C, et al. 1994. Effects of policosanol chronically administered in male monkeys (Macaca arctoides). Food Chem Toxicol 32:565-75.

19. Kabir Y, et al. 1994. Distribution of radioactive octacosanol in response to exercise in rats. Nahrung 38:373-7.

20. Kabir Y, et al. 1995. Tissue distribution of (8-14C)-octacosanol in liver and muscle of rats after serial administration. Ann Nutr Metab 39:279-84.

21. Castano G, et al. 1999. a double-blind, placebo-controlled study of the effects of policosanol in patients with intermittent claudication. Angiology 50:123-30.

22. Mas R, et al. 1999.Pharmacoepidemiologic study of policosanol. Curr Ther Res 60:458-67.

23. Mas R. 2000. Policosanol. Drugs of the Future 25:569-86.

MEDICAL STUDIES:

Int J Clin Pharmacol Res. 2001;21(1):43-57.

Effects of policosanol 20 versus 40 mg/day in the treatment of patients with type II hypercholesterolemia: a 6-month double-blind study.
Castano G, Mas R, Fernandez L, Illnait J, Gamez R, Alvarez E.
Medical Surgical Research Center, National Center for Scientific Research, Havana City, Cuba.

Policosanol is a well defined mixture of higher aliphatic primary alcohols isolated from sugar cane wax with cholesterol-lowering effects proven for a dose range from 5-20 mg/day in patients with type II hypercholesterolemia and dyslipidemia associated with noninsulin dependent diabetes mellitus. This randomized, double-blind study investigated the cholesterol-lowering efficacy and tolerability of policosanol 20 mg/day compared with 40 mg/day. Changes in low-density lipoprotein (LDL)-cholesterol levels were predefined as the primary efficacy endpoint. Patients with type II hypercholesterolemia were enrolled in the study and instructed to continue a step I cholesterol-lowering diet for 6 weeks and those eligible to be included (89) were randomly allocated to receive under double-blind conditions placebo (n = 30), policosanol 20 mg/day (n = 29) or 40 mg/day (n = 30). After 24 weeks, policosanol at 20 and 40 mg/day significantly (p < 0.00001) lowered LDL-cholesterol by 27.4% and 28.1%, total cholesterol (p < 0.00001) by 15.6% and 17.3%, and the LDL-cholesterol/high-density lipoprotein (HDL)-cholesterol ratio by 37.2% and 36.5%, respectively The ratio of total cholesterol/HDL-cholesterol was lowered by 27.1% and 27.5%, while HDL-cholesterol levels increased (p < 0.001) by 17.6% and 17.0%, respectively. Compared with baseline, policosanol 20 mg/day lowered triglycerides (p < 0.05) by 12.7%, while they were lowered (p < 0.01) by 15.6% at a dose of policosanol 40 mg/day All the above-mentioned significant differences were also different from placebo and no significant changes occurred in any lipid profile parameters in the placebo group. Based on the mean values of LDL-cholesterol levels at study completion, the mean percent reductions from baseline were 27.4% and 28.1% for the 20 and 40 mg/day groups, respectively. Thus, the effects of both policosanol doses on the main efficacy variable were practically identical. Consistent with the data obtained for LDL-cholesterol, both doses were similarly effective in changing all the other lipid profile parameters. No unexpected adverse effects were observed and there were no significant between-group differences regarding safety indicator values or reported adverse effects. In conclusion, although the tolerability profile remains excellent, according to the present results policosanol at a dose of 40 mg/day does not offer significant additional cholesterol-lowering efficacy over the 20 mg/day dose.

J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M186-92.

Effects of policosanol in older patients with type II hypercholesterolemia and high coronary risk.
Castano G, Mas R, Fernandez JC, Illnait J, Fernandez L, Alvarez E.
Medical Surgical Research Center, National Center for Scientific Research, Havana City, Cuba.

BACKGROUND: The present study was undertaken to investigate the effects of policosanol in older patients with type II hypercholesterolemia and more than one concomitant atherosclerotic risk factor. METHODS: After 6 weeks on a lipid-lowering diet, 179 patients randomly received a placebo or policosanol at doses of 5 followed by 10 mg per day for successive 12-week periods of each dose. Policosanol (5 and 10 mg/d) significantly (p < .001) reduced low-density lipoprotein cholesterol (LDL-C; 16.9% and 24.4%, respectively) and total cholesterol (TC; 12.8% and 16.2%, respectively), while significantly (p < .01) increasing (p < .001) high-density lipoprotein cholesterol (HDL-C) by 14.6% and 29.1%, respectively. RESULTS: Policosanol significantly decreased (p < .01) the ratios of LDL-C to HDL-C (29.1%) and TC to HDL-C (28%) at study completion, although triglycerides remained unchanged. Policosanol, but not the placebo, significantly improved (p .01) cardiovascular capacity, which was assessed using the Specific Activity Scale. No serious adverse experiences occurred in policosanol patients (p < .01), compared with seven adverse experiences (7.9%) reported by placebo patients. CONCLUSIONS: This study shows that policosanol is effective, safe, and well tolerated in older hypercholesterolemic patients.

Int J Clin Pharmacol Res. 1999;19(4):117-27.

Comparative study of the efficacy and tolerability of policosanol and lovastatin in patients with hypercholesterolemia and noninsulin dependent diabetes mellitus.
Crespo N, Illnait J, Mas R, Fernandez L, Fernandez J, Castano G.
Enrique Cabrera Hospital, Havana, Cuba.

This randomized, double-blind study was undertaken to compare the efficacy and tolerability of policosanol (10 mg/day) and lovastatin (20 mg/day) in patients with hypercholesterolemia and noninsulin dependent diabetes mellitus. After 6 weeks on a lipid lowering diet, 53 patients were randomized to receive either policosanol or lovastatin tablets that were taken o.i.d. for 12 weeks under double-blind conditions. Both groups were similar at randomization. Policosanol significantly (p < 0.001) lowered low-density lipoprotein (LDL)-cholesterol (20.4%), total cholesterol (14.2%) and the ratio of LDL-cholesterol to high-density lipoprotein (HDL)-cholesterol (23.7%). Lovastatin significantly (p < 0.01) lowered LDL-cholesterol (16.8%), total cholesterol (14.0%) and the ratio (p < 0.05) of LDL-cholesterol to HDL-cholesterol (14.9%). Triglyceride levels did not significantly change after therapy. Policosanol, but not lovastatin, significantly increased (p < 0.01) levels of HDL-cholesterol (7.5%). Comparison between groups showed that changes in HDL-cholesterol induced by policosanol were significantly greater (p < 0.01) than those induced by lovastatin. Both treatments were safe and well tolerated. Lovastatin moderately but significantly (p < 0.05) increased levels of aspartate aminotransferase, creatine phosphokinase and alkaline phosphatase. Adverse reactions were more frequent in the lovastatin group (p < 0.01) than in the policosanol group. IN CONCLUSION, policosanol administered at 10 mg/day produces more advantageous changes in HDL-cholesterol and has a better safety and tolerability profile than lovastatin 20 mg/day.

Int J Clin Pharmacol Res. 1995;15(4):159-65.

A two-year study on the efficacy and tolerability of policosanol in patients with type II hyperlipoproteinaemia.
Canetti M, Moreira M, Mas R, Illnait J, Fernandez L, Fernandez J, Diaz E, Castano G.
“Salvador Allende” Hospital, Havana, Cuba.

This is a report of the results of a two years’ randomized, double-blind placebo-controlled study of the efficacy, safety, and tolerability of policosanol administered at 5 mg twice-a-day in the treatment of type II hyperlipoproteinaemia. The study included 69 patients from both sexes, in whom total cholesterol and low-density-lipoprotein cholesterol (LDL-C) were not controlled sufficiently by diet. The treatment effect on total cholesterol and LDL-C was maintained during the 2-year follow up. Thus, percent reductions 24 months after therapy were 25% (LDL-C) and 18% (cholesterol). All comparisons with placebo were significant. Similarly, ratios of LDL-C to HDL-C and cholesterol to HDL-C were significantly reduced and such decreases were maintained during the study. Policosanol raised significantly the values of high-density lipoprotein cholesterol (HDL-C) during the study and maximal increases were reached 12 months after therapy (+21%). From this time the increases mildly declined to +14% and +11.2% respectively at 18 and 24 months after therapy. No significant changes in triglycerides were observed as compared with baseline or placebo. No patient withdrew from the study because of adverse effects. No drug-related clinical or biochemical adverse side-effects were observed. Any adverse experiences reported were mild and transient; moreover, no significant differences were obtained when compared with those reported by the placebo group. CONCLUSION: The results indicate that policosanol administered for two years to patients with type II hypercholesterolaemia shows a maintained efficacy as well as very good safety and tolerability.

Int J Clin Pharmacol Res. 1999;19(4):105-16.

Effects of policosanol and pravastatin on lipid profile, platelet aggregation and endothelemia in older hypercholesterolemic patients.
Castano G, Mas R, Arruzazabala ML, Noa M, Illnait J, Fernandez JC, Molina V, Menendez A.
Medical Surgical Research Center, Havana, Cuba.

This randomized, double-blind study was undertaken to compare the effects of policosanol and pravastatin administered at 10 mg/day on lipid profile, platelet aggregation and endothelemia in older patients with type II hypercholesterolemia and high coronary risk. After 6 weeks on a lipid-lowering diet, patients with low-density lipoprotein (LDL) cholesterol levels > 3.4 mmol/l were randomized to receive, under double-blind conditions, policosanol or pravastatin 10 mg tablets that were taken with the evening meal for 8 weeks. Policosanol significantly (p < 0.00001) lowered LDL-cholesterol (19.3%), total cholesterol (13.9%) and the ratios of LDL-cholesterol/high-density lipoprotein (HDL)-cholesterol (28.3%) and total cholesterol/HDL-cholesterol (24.4%). Pravastatin significantly (p < 0.00001) lowered LDL-cholesterol (15.6%), total cholesterol (11.8%) and the ratios (p < 0.0001) of LDL-cholesterol/HDL-cholesterol (18.9%) and total cholesterol/HDL-cholesterol (15.7%). Policosanol, but not pravastatin, significantly increased (p < 0.001) levels of HDL-cholesterol (18.4%) and reduced (p < 0.01) triglycerides (14.1%). Policosanol was more effective (p < 0.05) than pravastatin in inhibiting platelet aggregation induced by all agonists and it significantly reduced (p < 0.0001) platelet aggregation induced by arachidonic acid at 1.5 and 3 mmol/l by 42.2% and 69.5%, respectively, platelet aggregation induced by collagen 0.5 microgram/ml (p < 0.05) (16.6%) and that induced by adenosine diphosphate 1 mumol/l (p < 0.01) (20.3%). Pravastatin significantly reduced (p < 0.001) (27%) only platelet aggregation induced by arachidonic acid 3 mmol/l. Both drugs significantly decreased (p < 0.00001) endothelemia levels but final values were significantly lower (p < 0.001) in the policosanol than in the pravastatin group. Both treatments were safe and well tolerated. Pravastatin significantly (p < 0.01) increased serum levels of alanine amine transferase but individual values remained within normal. Two patients on pravastatin discontinued the study because of adverse experiences (myocardial infarction and jaundice, respectively). IN CONCLUSION, the effects of policosanol (10 mg/day) on lipid profile, platelet aggregation and endothelemia in older patients with type II hypercholesterolemia and high coronary risk are more favorable than those induced by the same doses of pravastatin.

Rev Med Chil. 1999 Mar;127(3):286-94.

Comparative effects of policosanol and two HMG-CoA reductase inhibitors on type II hypercholesterolemia.
[Article in Spanish]
Prat H, Roman O, Pino E.
Centro Cardiovascular Hospital Clinico Universidad de Chile.

BACKGROUND: Policosanol is a new cholesterol lowering agent derived from sugar cane. AIM: To compare the cholesterol lowering efficacy of policosanol with HMG CoA inhibitors. PATIENTS AND METHODS: Patients with a LDL cholesterol over 160 mg/dl were studied. If, after 6 weeks of diet, cholesterol persisted elevated, they were doubly blind randomized to receive policosanol 10 mg/day (55 patients), lovastatin 20 mg/day (26 patients) or simvastatin 10 mg/day (25 patients). Serum cholesterol was measured again after 8 weeks of therapy. RESULTS: Initial demographic and laboratory data were similar among treatment groups. A 24% LDL cholesterol reduction was obtained with policosanol, compared with a 22% reduction with lovastatin and a 15% reduction with simvastatin. HDL cholesterol significantly increased in patients on policosanol and did not change in the other treatment groups. Adverse effects of policosanol were mild and unspecific. No changes in hepatic enzymes were observed. CONCLUSION: Policosanol is a safe and effective cholesterol reducing agent.

SUPPLEMENTARY INFORMATION

There are currently 6 statins on the market:

* atorvastatin (Lipitor)
* fluvastatin (Lescol)
* lovastatin (Mevacor)
* pravastatin (Pravachol)
* simvastatin (Zocor)
* rosuvastatin (Crestor)
_________________________________________

SERIOUS SIDE EFFECTS OF STATIN DRUGS

1. Depletes CoEnzyme Q from the liver which will cause:
* congestive heart failure (CHF has increased 600% since 1997 when the statin drugs were introduced)
* muscle weakness
* tiredness & malaise
* destruction of muscle cells (Rhabdomyolysis)
* exercise intolerance

2. Can cause neurological disorders like:
* nerve degeneration
* harmful effects on brain function
* ADD – Attention Deficit Disorder
* delayed reflexes
* decreased memory (dementia) and cognitive impairment
* depression
* dizziness due to lowered blood pressure, esp in the elderly
* personality changes and irritability
* weakness, tingling & pain in the extremeties (idiopathic polyneuropathies)
* increased risk for permanent nerve damage
* Alzheimer’s patients are more susceptible to brain damage

3. Powerful chronic suppression of the immune cells — T- Helper Cells causing:
* cancer
* fungal infections
* bacterial infections
* viral infections

4. Liver dysfunction causing:
* increase in liver enzymes
* liver failure

5. Pancreatitis – The medical literature contains several reports of swollen pancreas in patients taking statin drugs, esp simvastatin & lovastatin.

6.. HDL Cholesterol (good cholesterol) – statins have no effect on raising HDL levels & studies have shown that the statins can actually lower HDL.

7.. Glucose Levels – statins have been known to increase blood glucose levels.
So why would the M.D.’s want to put all diabetics on statins??

The other lesser side effects of note in the medical literature are the old standbys of: nausea, diarrhea and constipation.

NOTE: As a former Registered Pharmacist I can tell you that every drug that has been on the market to lower cholesterol has been taken off the market because these drugs cause serious liver damage. See the two most recent drugs that have caused so many problems that one is now off the market (Baycol) & the other (Crestor) has had their ads taken off the air.