FORCEFUL INGREDIENT INFO General Description: Cardiovascular disease has been the number one cause of death in the United States every year since 1900, except 1918 when influenza killed more people. Cardiovascular diseases are comprised of four main classifications: Coronary Heart Disease (CHD), Hypertensive Disease, Rheumatic Heart Disease, and Stroke (Cerebrovascular) Disease. In 1998 (the last year for which statistics were completed), there were 949,619 deaths due to cardiovascular diseases. Forty-eight percent of these deaths (459,841) were due to coronary heart disease. Single-handedly, CHD is the leading cause of American deaths, regardless of gender. It is further estimated that 12,400,000 Americans suffer from coronary heart disease. The economic cost associated with cardiovascular disease is phenomenal, with the direct and indirect costs for CHD in the United States estimated to be about 100.8 billion, annually. Coronary heart disease includes damage to the heart or pain in the heart because of obstructed blood flow due to arteriosclerosis in the coronary arteries. Arteriosclerosis is defined as a buildup of cholesterol and fat within the walls of the arteries. The process can begin in childhood and worsen with age. High total cholesterol levels; high low-density lipoprotein (LDL) cholesterol; low high-density lipoprotein (HDL) cholesterol; high rates of oxidation of LDL (recently revealed that high oxidized LDL levels coincide with severity of acute coronary syndromes); and high levels of homocysteine increase the risk for coronary heart disease. Other contributing factors that lead to heart disease are high blood pressure, smoking, obesity, and physical inactivity. Policosanol: Policosanol is a natural mixture of eight relatively high molecular weight alcohols that have been isolated and purified from sugar cane wax (Saccharum officinarum L.). Its main component is octacosanol. The other components are triacontanol, hexacosanol, tetracosanol, heptacosanol, nonacosanol, dotriacontanol, and tetratriacontanol. Policosanol is a cholesterol-lowering agent, with blood thinning properties. The benefits of policosanol have been studied both in animals and in humans with few detrimental side effects being witnessed.[3, 4] Many studies using policosanol have been performed on persons with hypercholesterolemia or hyperlipidemia, some of the studies lasting as long as two years. A daily dose of ten milligrams of policosanol has shown on average to reduce total cholesterols by 16.5% and LDL (“bad cholesterol”) by 24.2%, while increasing HDL (“good cholesterol”) levels by 17%.[3, 4, 6] In other studies, policosanol has been shown to reduce platelet aggregation, lower total cholesterol and LDL,[8, 9] raise HDL,[5, 9] inhibit thromboxane, but not prostacyclin, improve symptoms of intermittent claudication[11, 12]and improve cardiovascular capacity.[13, 14] Persons with coronary heart disease showed improvement in myocardial ischemia. When tested against other drugs, policosanol was found to be as effective at lowering total cholesterol and LDL/HDL ratio. This ratio needs to be more balanced, especially in America where epidemiologic studies show that LDL is too high and the HDL is too low. Policosanol was found to be better tolerated than acipimox and pravastatin. It produced more preferential changes in HDL cholesterol and was better tolerated than lovastatin or simvastatin. It was equally effective at reducing platelet aggregation as aspirin and some studies have found a synergistic effect between policosanol and aspirin.[7, 18-20] In healthy persons, policosanol reduced oxidation of LDL cholesterol and reduced platelet aggregation. Policosanol is well tolerated by human subjects. Patients who took policosanol had no more adverse events than those patients who took placebo.[3, 4] In addition, policosanol has a wide safety margin after oral administration.[22, 23] Studies in animals found no evidence of carcinogenicity,[22, 24] toxicity, or teratogenicity.[26, 27] Although policosanol is well tolerated, there are reports that some side effects do occur, including: erythema, migraines, insomnia, somnolence, irritability, dizziness, upset stomach, polyphagia, dysuria, weight loss, skin rash, and nosebleeds. Oleuropein: Studies of the Mediterranean diet show that olive oil may provide protection from a variety of diseases, including arteriosclerosis. Olive oil has been studied to determine its role as a heart protectant. One of the components of olive oil that has been studied because of its active nature is oleuropein, a bitter phenolic compound derived from olives. A laboratory study showed that oleuropein inhibited the oxidation of LDL cholesterol as measured by conjugated dienes, while reducing total cholesterol by 15%, free cholesterol by 12%, and ester cholesterol by 17%. Oxidized LDL cholesterol contributes significantly to the formation of arteriosclerotic lesions and thus the severity of symptoms associated with coronary heart disease. Thus, by inhibiting this oxidation, oleuropein may also protect against arteriosclerosis. In vitro, oleuropein protected LDL from oxidation by copper sulfate for over 6 hours (without oleuropein the LDL was completely oxidized in 30 minutes). Oleuropein also has the added benefit of reducing blood pressure.[33, 34] Oleuropein is considered safe in amounts that could be found in a diet high in olive oil. A diet high in olive oil ranges from 178 mg to 312 mg a day.[32, 35-37] No side effects were reported. Folic Acid: Folic acid (pteroylmonoglutamic acid) is an essential B vitamin. Typically the average diet in the USA does not provide enough of this essential nutrient, which often necessitates the use of a supplement. The RDA for adult males is 200µg, adult females 180µg, and pregnant females 400µg. Epidemiological studies serve to strengthen the correlation between elevated plasma homocysteine and a higher risk for CHD.[39, 40] Some cases of high homocysteine are not a result of nutritional deficiency; genetically some people do not produce enough enzymes to process homocysteine. Also, kidney disease, psoriasis, medications, or low amounts of thyroid hormone contribute to high homocysteine levels. In other cases, nutritional deficiency may increase homocysteine levels. In most of these situations, homocysteine levels can be lowered and maintained by supplementing the diet with folic acid.[42-48] According to Malinow, a meta-analysis of 12 clinical trials shows an estimated 25% reduction in homocysteine concentration could be achieved with folic acid supplementation, and therefore, a reduced risk for CHD. Plasma folic acid levels have a strong inverse relationship with homocysteine levels. It has now been demonstrated that folic acid can reduce and maintain homocysteine levels, which can help prevent some cardiovascular disease. [47, 49] Folic acid is an essential, safe, and non-toxic vitamin in standard recommended doses. Interference with the absorption of folic acid by the body can happen with medications such as oral contraceptives, corticosteroids, barbiturates, phenytoin and other anti-seizure medications, sulfa drugs, some antibiotics, some anticancer drugs, and high-dose aspirin. Vitamin B12: Vitamin B12 is a naturally occurring B complex vitamin that can be found in some foods of animal origin. The synthetic form of vitamin B12 is known as cyanocobalamin. A certain percentage of middle aged and elderly people “mal-absorb” naturally occurring vitamin B12 and should take a supplement. Unfortunately, not all people are able to absorb vitamin B12 from the gastro-intestinal tract due to a lack of intrinsic factor. These people may require injected or nasally administered B12. Vitamin B12 supports folic acid in reducing plasma homocysteine levels, making it essential to the utilization of folic acid.[42-48] The combination of these two important vitamins facilitates proper metabolism of homocysteine. Additionally, folic acid can mask low-grade vitamin B12 deficiency, which eventually leads to pernicious anemia and results in irreversible nerve damage. Concurrent administration of B12 and folic acid can eliminate this possible “masking” affect. Furthermore, vitamin B12 deficiency has an impact on homocysteine concentration itself, although the reduction is not as significant as with folic acid. Another observation by Malinow demonstrates that beside the 25% reduction of homocysteine concentrations with folic acid, an additional 7% reduction occurred with vitamin B12 supplementation. Thus a 32% reduction in homocysteine is possible by administering folic acid and vitamin B12. Vitamin B12 is an essential, safe, and non-toxic vitamin in standard recommended doses. There are certain medications that can interfere with the absorption of vitamin B12 such as those that increase urinary flow, and those that stimulate the liver. A qualified health care practitioner should evaluate possible interactions with these medications. __________________ References: 1. American Heart Association, 2001 Heart and Stroke Statistical Update. 2000, American Heart Association: Dallas, Texas. 2. National Heart, L., and Blood Institute, Facts about Coronary Heart Disease. 1993, NIH Publication No. 93-2265: Bethesda, Maryland. p. 1-7. 3. Más, R., G. Castano, J. Illnait, L. Fernandez, J. Fernandez, C. Aleman, V. Pontigas, and M. Lescay, Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors. Clin Pharmacol Ther, 1999. 65(4): p. 439-47. Center of Natural Products, National Center for Scientific Research, Havana City, Cuba. 4. Torres, O., A.J. Agramonte, J. Illnait, R. Mas Ferreiro, L. Fernandez, and J.C. Fernandez, Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care, 1995. 18(3): p. 393-7. Julio Trigo Hospital, Havana, Cuba. 5. Canetti, M., M. Moreira, R. Mas, J. Illnait, L. Fernandez, J. Fernandez, E. Diaz, and G. Castano, A two-year study on the efficacy and tolerability of policosanol in patients with type II hyperlipoproteinaemia. Int J Clin Pharmacol Res, 1995. 15(4): p. 159-65. "Salvador Allende" Hospital, Havana, Cuba. 6. Pons, P., M. Rodriguez, C. Robaina, J. Illnait, R. Mas, L. Fernandez, and J.C. Fernandez, Effects of successive dose increases of policosanol on the lipid profile of patients with type II hypercholesterolaemia and tolerability to treatment. Int J Clin Pharmacol Res, 1994. 14(1): p. 27-33. Plaza Polyclinical Centre, Havana, Cuba. 7. Arruzazabala, M.L., R. Mas, V. Molina, D. Carbajal, S. Mendoza, L. Fernandez, and S. Valdes, Effect of policosanol on platelet aggregation in type II hypercholesterolemic patients. Int J Tissue React, 1998. 20(4): p. 119-24. Center of Natural Products, National Center for Scientific Research, Havana, Cuba. 8. Batista, J., R. Stusser, F. Saez, and B. 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