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Cardiovascular Health – The 21st Century Approach

14 / 01 / 2011

The following facts about cardiovascular disease are scary…but indisputable.

 ● According to the most recent statistics available, cardiovascular disease is the #1 killer of women and men.

● 1 out of 5 women, and 1 out of 6 men will be affected by cardiovascular disease.

● Cardiovascular disease will claim more lives than the next five causes of death combined.

● Over 100 million Americans have cholesterol levels of 200mg/dl or higher, which is associated with a sharp increase in the number of deaths from cardiovascular disease.

  

ARE  YOU  AT  RISK?  CONSIDER  THIS!

 Your heart will beat approximately 39 million times this year. This equates to an amazing three billion heartbeats over an average lifetime. Normal heart function requires a constant, uninterrupted flow of oxygen, which works with the energy producing apparatus of the heart muscle to maintain a coordinated heartbeat and strong contraction.

A “heart attack” occurs when a blockage occurs in a blood vessel in the heart and starves the heart muscle of vital oxygen. Every year, 1.5 million Americans – one about every 30 seconds – DIE nearly instantly from an acute heart attack. This may be why Lipitor® is the #1 selling drug in the United States by dollar amount ($12 billion), and why the cardiovascular health prescription drug market has grown to over $30 billion annually.

  

RED  YEAST  RICE…NOT  ALL  PRODUCTS  ARE  CREATED EQUAL!

Some strains of Chinese red yeast rice, when prepared by solid fermentation, produce compounds called monacolins that inhibit cholesterol production. When used as a dietary supplement to achieve and maintain healthy cholesterol levels, Chinese red yeast rice has significant potential to reduce health care costs and contribute to public health by reducing heart disease risk in individuals with moderate elevations of circulating cholesterol levels. Although one proprietary strain of Chinese red yeast rice, the only strain used by Hi-Tech Pharmaceuticals Inc., has been demonstrated to lower cholesterol levels significantly in clinical trials, other strains sold as Chinese red yeast rice dietary supplements have not undergone similar evaluation.

In a recent test, the following disappointing facts were revealed:

          1. Only 10% of all red yeast rice products had the full spectrum of active components.

          2. Total active components varied from 0% to 0.58%.

          3. Citrinin, which is a toxic byproduct of fermentation of red yeast rice (measured by  radioimmunoassay) was found at measurable concentrations in 70%

              of the preparations.

Red yeast rice contains starch, fatty acids (oleic, linoleic, palmitic, stearic), phytosterols (beta-sitosterol, stigmasterol), isoflavones, and active components that possess hydroxymethylglutaryl Coenzyme A (HMG-CoA) reductase – inhibitory activity. HMG-CoA reductase inhibitors have a positive influence on the synthesis of cholesterol. The first  HMG-CoA reductase inhibitor intraduced in the U.S. for use as a cholesterol-lowering agent, was lovastatin. Lovastatin was originally derived from monascus rubber, and was first called monacolin K. Monacolin K is a lactone  which is converted in the body to the active form of the statin, the corresponding beta-hydroxy acid of monacolin K (lovastatin, mevinolin).

Hi-Tech Pharmaceuticals’ proprietary red yeast rice, which was first introduced in the U.S. in 2000, is processed to yield a total of nine different HMG-CoA reductase inhibitors. Traditional red yeast rice does not contain as high amount of these substances.

  

WHAT  IS  THE  COMPOSITION  OF  HI-TECH’S  RED  YEAST  RICE EXTRACT™?

Scientists at Hi-Tech Pharmaceuticals and Pharmatech, Ltd. analyzed the profile of Hi-Tech’s proprietary strain of red yeast rice. The composition by weight is starch (70%), protein (10.7%), moisture (5.4%), unsaturated fatty acids (1.5%), HMG-CoA reductase inhibitors (4%), ash (2%), and trace amounts of minerals. There are no additives, preservatives, heavy metals, or undesirable substances, such as citrinic acid.

The same HMG-CoA reductase inhibitors found in the leading cholesterol-lowering drugs are believed to be the main cholesterol-lowering agents in Hi-Tech Red Yeast Rice Extract™ and also Hi-Tech’s multi dimensional cholesterol management product, Choledrene®.

Hi-Tech Red Yeast Rice™ contains 9.46mg HNG-CoA reductase inhibitors, per tablet, versus an average of 2.39mg, per tablet or capsule, in four other products manufactured by reputable dietary supplement companies:

          1. Hi-Tech Red Yeast Rice Extract™ – 9.46mg

          2. Pharma Resources Red Yeast Complex – 1.25mg

          3. Nature’s Purest Cholest Factors – 2.19mg

          4. Nature’s Sunshine Red Yeast Rice – 2.85mg

          5. Soloray Red Yeast Rice – 3.26mg

As stated, reputable dietary supplement companies produce these other four products and, thus, these products are considered to be quality products by industry standards, especially since many red yeast rice products being sold actually contain no detectable active components at all! However, it is clear that the industry standard is certainly not the Hi-Tech Pharmaceuticals standard. Apparently, Hi-Tech Pharmaceuticals is the standard by which other dietary supplement companies will never measure up to.

Because none of the components are purified or synthesized, Hi-Tech’s product contains a mixture of the nine yeast-producing HMG-CoA reductase inhibitors, unsaturated fatty acids, and other antioxidants. Many scientists believe that these other compounds, unsaturated fatty acids, and antioxidants may work together favorably with primary HMG-CoA reductase inhibitors to enhance their cholesterol-lowering effects, as well as its ability to lower triglycerides and increase HDL cholesterol. HDL is regarded as the “good” form of cholesterol. High levels of HDL cholesterol protect against heart attacks, because HDL preferentially delivers the cholesterol it transports to the liver for metabolism, rather than to the arterial walls where cholesterol builds up to form plaque. LDL cholesterol, on the other hand, preferentially shuttles the cholesterol it transports through the bloodstream directly to the arterial walls.

  

MECHANISM  OF  ACTION

The mechanism of the hypolipidemic activity of red yeast rice is not entirely clear. The possible hypocholesterolemic activity of red yeast rice can be accounted for, in part, by the presence of HMG-CoA reductase inhibitors, which interfere with cholesterol biosynthesis. This activity is known to lower plasma total cholesterol, low-density lipoprotein cholesterol (LDL-C), the total cholesterol/HDL-C ratio and the LDL-C/HDL-C ratio. It may also produce a modest increase in HDL cholesterol and modest decreases in VLDL-C and triglyceride levels in some.

LDL is formed from VLDL and is principally catabolized via the high affinity LDL receptor. The mechanism in lowering LDL appears to also involve reduction of VLDL-C levels and upregulation of the LDL receptor, resulting in reduced production of LDL-C, as well as increased catabolism of LDL-C.

The Hypolipidemic effects of red yeast rice have been found to be greater than those obtained from equivalent doses of the pharmaceutical form of lovastatin. To be clear about this, the amount of active components delivered by red yeast rice is typically 7.2mg. The amount of lovastatin in the pharmaceutical form of lovastatin ranges from 10 to 40 milligrams. It is unclear why an active components dose of 7.2mg in red yeast rice appears to have more potent lipid-lowering activity than higher doses of pharmaceutical lovastatin. It is speculated than other substances in red yeast rice other than the HMG-CoA reductase inhibitors may have lipid-lowering activity themselves or may work synergistically with the HMG-CoA reductase inhibitors.What these substances are and how they may work synergistically with the HMG-CoA reductase inhibitors, is entirely unclear. Beta-sitosterol is found in red yeast and it is known to have hypocholesterolemic activity. However, the amount of these substance found in red yeast rice is too small to make much of a cholesterol-lowering contribution.

 

RESEARCH  SUMMARY

Recent clinical studies have demonstrated that red yeast rice can significantly lower triglyceride and cholesterol levels in some individuals. In one multi-center, randomized, single-blind trial of the substance in 502 patients with hyperlipidemia, there was a 17% reduction of total cholesterol in the treated group. LDL cholesterol rose by 12.8% in the treatment group.

These results were measured after four weeks of treatment. Dosage was 600mg of red yeast rice twice daily for a total  of 1,200mg daily, At the end of eight weeks of red yeast rice supplementation, even better results were reported for the treatment group: total cholesterol was reduced by 22.7%, LDL cholesterol was reduced by 30.9%, triglycerides were reduced by 34.1%, and HDL cholesterol increased by 19.9%.

In another recent study, this one conducted in a double-blind, placebo-controlled fashion, 83 hyperlipidemic subjects, who were not being treated with lipid-lowering drugs, were randomized to receive red yeast rice, 2.4mg daily, or placebo. Subjects were instructed to consume a diet deriving 30% of energy from fat (with no more than 10% of this from saturated fat and no more than 300mg of cholesterol daily).

The study continued for 12 weeks. Red yeast rice was found to significantly reduce total cholesterol, LDL cholesterol, and total triacylglycerol concentrations, as compared with placebo. HDL cholesterol was not affected in this study. Research is ongoing. Also ongoing, is the legal issue regarding the status of lipid-lowering red yeast rice as a dietary supplement.

 

CHOLEDRENE®  –  THE  SAFE,  NATURAL,  AND  SCIENTIFIC  APPROACH TO HEALTHY  CHOLESTEROL  LEVELS

Hi-Tech Pharmaceuticals first released its superior quality red yeast rice extract several years ago within the formulation of its flagship cardiovascular health product, Choledrene®. Choledrene® is a totally comprehensive cardiovascular support formula that incorporates numerous other cholesterol-lowering agents and antioxidants, and also includes liver cofactors to assist in maintaining healthy liver function, due to the tendency of HMG-CoA reductase activity to contribute to enhanced liver metabolism. Many people use Choledrene® in tandem with Hi-Tech Red Yeast Rice Extract™ when desiring to maximize cardiovascular support, and when genetically-dictated, above normal cholesterol levels require higher levels of HMG-CoA reductase activity to effectively lower cholesterol within acceptable limits. Choledrene® incorporates the following proprietary blend:

Monascus purpureus – This compound has traditionally been used as a “blood purifier”. However, modern clinical research has demonstrated that monascus purpureus effectively produces a number of active compounds that are identical to the expensive, prescription medications used by physicians for treating patients with elevated blood cholesterol. The active components lower blood cholesterol by inhibiting its synthesis in the liver. Coenzyme Q10 – Due to the natural tendency of these substances to deplete Coenzyme Q10 (an important energy source for the heart), this component has been incorporated to support efficient energy production in heart cells. Pyridoxine, cyanocobalamine, and folic acid – Medical research has confirmed that too much homocysteine in the blood may play a greater role in the early development of atherosclerosis  than cholesterol (which becomes the dominant factor in the intermediate and advanced stages). Pyridoxine, cyanocobalamine, and folic acid work together to lower homocysteine in the blood, supporting the body’s natural ability to prevent the onset of atherosclerosis. Further evidence has shown  that people with higher levels of serum folic acid (a natural result of taking pyridoxine, cyanocobalamine, and folic acid) have a 50% LESS likelihood of dying from heart disease! L-Carnitine – This biochemical is necessary to maintain optimal metabolic function of cells. Specifically, L-Carnitine supports heart function in its continuous need for energy. Magnesium pyruvate – This synergistic combination serves a dual purpose: 1) It supports the heart’s need to maintain a normal heart rhythm, and 2) It serves as a fundamental energy source for heart cells. L-Arginine – This natural amino acid stimulates the body’s release of nitric oxide, which is essential to the health of the heart, blood vessels, and nervous system. This mechanism, in fact, is so critical to cardiovascular health that American and Swedish scientists were awarded the Nobel Prize in Medicine in 1998 for their research on nitric oxide. According to a recently published book, The Arginine Solution, L-Arginine “opens clogged arteries, lowers blood pressure and cholesterol, and reduces your risk of heart disease and stroke”. Silymarin (milk thistle) – This compound, derived from all natural sources, has traditionally been used to protect the liver from harm caused by chemicals. Even though HMG-CoA reductase inhibitors are extraordinarily safe, their function IS to inhibit cholesterol synthesis in the liver; therefore, liver function in this process is supremely important. Including a “protecting” agent such as this is one of the MANY reasons why Choledrene® cannot be matched in today’s market for over-the-counter “cholesterol-managing” agents. Proprietary antioxidant blend – “Bad”  or LDL cholesterol is believed to be particularly dangerous because of its propensity for becoming “oxidized”. This “oxidation” can be inhibited by the proprietary antioxidant blend that has been scientifically formulated specifically for Choledrene®. This component was included to support the normal, healthy structure and function of blood vessels. This blend also contains grape seed extract.

As you can see, the Research and Development team at Hi-Tech Pharmaceuticals has left nothing to chance in the formulation of Choledrene®. This advanced formulation CLEARLY covers all the bases and is GUARANTEED to become the benchmark product in the nonprescription market for cholesterol management and cardiovascular support!

Choledrene® Treatment and its Cholesterol-lowering Effects

  Total Cholesterol LDL Tryglycerides HDL
Baseline 225 172 150 40
8 Weeks   174 129 119 49
% Change from baseline - 23% - 25% - 21% + 23%

 

QUALITY  MATTERS

 The findings from the Choledrene® data demonstrate significant and clinically relevant cholesterol reduction using a defined Chinese red yeast rice preparation containing nine different HMG-CoA reductase inhibitors. This outcome cannot be generalized to preparations that do not contain the same levels and profile of these components. Standardized manufacturing practices should be established for Chinese red yeast rice sold as a dietary supplement, in order to ensure equivalence of content of active ingredients in preparations being sold to the public, and to limit the production of unwanted byproducts of fermentation, such as citrinin. Hi-Tech is the leader in standardization of red yeast rice. Whether you choose Hi-Tech’s Red Yeast Rice Extract™ (600mg) single ingredient product or Choledrene®, the revolutionary breakthrough in cardiovascular health, you have nothing to lose… and only your health to gain.


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