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Do the New Guidelines for Statins Make Sense?

The American Heart Association (AHA) and American College of Cardiology (ACC) released four new guidelines dealing with the prevention of cardiovascular disease (CVD). The big news is that doctors are now being urged to move away from specific targets for cholesterol and instead focus on clinical assessment of risk.

Unfortunately, the misguided recommendation will be to increase the focus on prescribing statins rather than important dietary and lifestyle recommendations. Under the current guidelines that target blood lipids, statins are recommended for about 15 percent of adults. With the new guidelines, 44 percent of men and 22 percent of women would meet the criteria for taking a statin.

The answer to the question “Do the New Guidelines for Statins Make Sense?” is “yes,” if the measure is providing further big profits to the drug industry. I think the new guidelines are an acknowledgement of the failure of statins to produce an increase in life expectancy for 80 percent of the patients the drugs are being prescribed to. Further, in my opinion, increasing the number of Americans being prescribed statins will only increase the number of people these drugs will provide abso-lutely no benefit to and likely only increase the problem of statininduced side effects.

On the positive side, these new Guidelines give retailers a great opportunity to educate their customers on a more comprehensive approach to heart health, as well as safe and effective alternatives to statins.

What Retailers Need to Know

The new guidelines are not based on any new data, rather an interpretation of prior data by the ACC/AHA Task Force on Practice Guidelines. The conclusion of the review was to give recommendations that ultimately focused on four groups of individuals identified as being strong candidates for statin use:

• Individuals with clinical CVD.

• Individuals with primary elevations of LDL–C =190 mg/dl.

• Individuals 40 to 75 years of age with diabetes.

• Individuals without clinical CVD or diabetes who are 40 to 75 years of age with an estimated 10-year CVD mortality risk of 7.5 percent or higher.

Using a risk calculator developed by the task force can identify individuals in the last group, but the entire validity of the risk calculator has come under fire as it severely overstates the need for statins. The equation considers age, sex, total and HDL cholesterol, systolic blood pressure, blood pressure treatment, diabetes and smoking.

Do Statins Increase Life Expectancy?

While the medical literature does show That in people with a history of a heart attack, stroke or current signs and symptoms of existing CVD, statins do produce some benefits in reducing deaths due to a heart attack. However, the results of studies in people without a history of heart attack or stroke who took statin drugs have shown they do not live any longer than the people in the placebo group. For example, the largest and most thorough review of statins analyzed 11 clinical trials involving 65,229 participants and was published in the Archives of Internal Medicine in June 2010. The analysis provides the most reliable evidence available on the impact of statin therapy on all-cause mortality among high-risk individuals without prior CVD. The results showed that the use of statin therapy did not result in reduction in allcause mortality in these high-risk patients.

About 75 percent of the prescriptions for statins are written for people with no clinical evidence of CVD. And, since statins have not been shown to increase life expectancy in these patients, the easy conclusion is that the majority of people on statin drugs are achieving no real benefit from them. In fact, in my opinion, relying on these drugs and not focusing on effectively reducing heart disease risk through diet, lifestyle and proper nutritional supplementation is costing many people their lives.

Are Statins Safe?

While drug companies and many doctors state that statins are so safe and effective they should be added to drinking water, the reality is that they are very expensive medicines, provide very limited benefit and carry with them considerable risks for side effects. For example, a 2012 study by the Mayo Clinic found that the use of statins in postmenopausal women increased their risk for type 2 diabetes by 74 percent. Some of the other side effects noted with statins include the following:

• Liver problems and decreased liver function

• Interference with the manufacture of coenzyme Q10 (CoQ10), a key substance responsible for energy production within the body

• Rhabdomyolysis, or the breaking down of muscle tissue, which can be fatal

• Nerve damage—the chances of nerve damage are 26 times higher in sta-tin users than in the general population

• Impaired mental function with prolonged use

• Possible increased risk of cancer and heart failure with long-term use

• Increased muscle damage caused by exercise and reduced exercise capacity

• Worsening energy levels and fatigue after exertion in about 20 percent of cases

Statins & CoQ10

Despite research documenting the benefits of non-drug approaches to lowering cholesterol, it is unlikely that lowering LDL with statin drugs will be supplanted as the primary therapy in lipid management and prevention of CVD anytime in the near future. Therefore, the focus for many will be on the support of statin therapy. For example, it appears that individuals taking statin drugs need to supplement with CoQ10. The enzyme blocked by statins (HMGCoA reductase) is not only required for the synthesis of cholesterol in the body, but also CoQ10. Thus, taking a statin drug can severely compromise CoQ10 status by decreasing its synthesis.

Even modest dosages of various statins have been shown to lower blood CoQ10 levels considerably. Researchers Have concluded that inhibition of CoQ10 synthesis by statin drugs could explain the most commonly reported side effects, especially fatigue and muscle pain, as well as the more serious side effects such as severe muscle damage (rhabdomyolysis). CoQ10 supplementation in subjects on statin drugs has been shown to reduce markers of oxidative damage and improve tolerance to these drugs. The recommended dosage is 100 mg twice daily in patients taking a statin.

Natural Alternatives

It is important to point out that diet can be as effective as statins in lowering cholesterol levels in many people with high cholesterol levels. In particular, there have been 10 clinical studies on the “Portfolio Diet” comprised of plantbased cholesterol-lowering foods in lowering cholesterol with great results.

For example, in one study participants were randomly assigned to undergo one of three interventions on an outpatient basis for one month: a diet low in saturated fat; the same diet plus lovastatin (20 mg/day); or a diet high in plant sterols (1 g/1,000 kcal), soy protein (21.4 g/1,000 kcal), viscous fibers (9.8 g/1,000 kcal) and almonds (14 g/1,000 kcal). The control, statin and dietary portfolio groups had average decreases in LDL of 8, 30.9 and 28.6 percent, respectively. Respective reductions in the inflammatory marker CRP were 10, 33.3 and 28.2 percent, respectively. This study and others show that a diet rich in cholesterol-lowering components produces results comparable to a statin drug, but without the side effects.

As far as natural cholesterol-lowering products, three are worthy of special mention:

• Red Yeast Rice: Statin drugs owe their origin to red yeast (Monascus purpureus) fermented on rice. This traditional Chinese medicine has been used for its health-promoting effects in China for more than 2,000 years. Red yeast rice is the source of a group of compounds known as monacolins (e.g., lovastatin, also known as monacolin K, one of the key monacolins in red yeast rice extract). The marketing of extracts of red yeast fermented on rice standardized for monacolin content as a dietary supplement in the United States Caused controversy in 1997 because it contained a natural source of a prescription drug. The FDA eventually ruled that red yeast rice products could only be sold if they were free of monacolin content.

Studies have shown that red yeast rice-containing monacolins can significantly lower levels of total cholesterol and LDL cholesterol. One showed that taking 2.4 g per day of red yeast rice reduced LDL levels by 22 percent and total cholesterol by 16 percent in 12 weeks. Another study showed that taking 1. 2 g per day lowered LDL levels by 26 percent in just eight weeks.

However, it must be pointed out that since the FDA only allows red yeast rice products to be sold if they do not contain monacolins, it is not known what effects that these sorts of products have on cholesterol levels.

• Niacin: Since the 1950s niacin (vitamin B3) has been known to be effective in lowering blood cholesterol and triglyceride levels. In fact, in numerous clinical studies niacin has demonstrated better overall results in reducing risk factors for coronary heart disease than other cholesterol-lowering agents including statin drugs. Nonetheless, many people are reluctant to use niacin, primarily because it causes a hot, itchy skin reaction known as the “niacin flush” at the levels recommended to lower cholesterol.

In an attempt to combat the acute reaction of skin flushing, manufacturers developed sustained-release—also called timed-release or slow-release— niacin products. These formulations allow the niacin to be absorbed gradually, thereby reducing the flushing reaction. Unfortunately, these earlier timedrelease preparations were shown to be more toxic to the liver than regular niacin.

This problem has been overcome with the development of newer timedreleased preparations, referred to as “intermediate release” because the niacin is released steadily over a 6-8 hour period versus the slower release of previous preparations (12 hours or more). As a result, it was shown that lower dosages of the intermediate form (e.g. 1,000 to 2,000 mg given once at night) were as effective in improving blood lipids (fats) as larger dosages of The older forms (3,000 mg). Very large clinical trials have shown intermediaterelease niacin preparations to be extremely well tolerated with no liver toxicity or serious side effects noted.

Niacin’s impact on lipid metabolism and cholesterol is well researched, and there is abundant clinical evidence for both niacin’s safety and its effectiveness. Niacin typically lowers LDL cholesterol levels by 16 to 23 percent while raising HDL cholesterol levels by 20 to 33 percent. These effects, especially on HDL, compare quite favorably with conventional cholesterol-lowering drugs, including statins—the most widely prescribed drug treatment for high cholesterol. In addition, some studies have shown that niacin used in conjunction with statins significantly improves patient outcomes, as opposed to using statins alone.

• Polymethoxylated Flavones: Sytrinol is a special extract of citrus peel standardized to contain greater than 30 percent polymethoxylated flavones. This mixture provides a comprehensive formula that addresses high cholesterol, high LDL cholesterol and high triglyceride levels.

Sytrinol works by blocking the enzymes in the liver responsible for manufacturing cholesterol and triglyceride production. For example, the polymethoxylated flavones in the extract have been shown to decrease the production of apolipoprotein B, a structural protein needed for endogenous synthesis of LDL cholesterol.

Clinical results have shown that Sytrinol exerts effects very similar to statin drugs, but without side effects. Specifically, it has been shown to lower total cholesterol levels up to 30 percent, LDL cholesterol levels up to 27 percent and triglyceride levels up to 34 percent within four to 12 weeks of use. The recommended dosage is 150 mg twice daily.

Final Comments

The benefits of the longer chain omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA) to cardiovascular health has been demonstrated in more than 300 clinical trials. Supplementation with EPA + DHA has little effect on cholesterol levels, but does lower triglyceride levels significantly, as well as produce a myriad of additional beneficial effects in protecting against CVD. In general, for preventive effects against CVD, the dosage recommendation is 1,000 mg EPA+DHA per day, but for lowering triglycerides the dosage is 3,000 mg EPA + DHA.

Michael T. Murray, ND, is widely regarded as one of the world’s leading authorities on natural medicine. He is a graduate, former faculty member and serves on the Board of Regents of Bastyr University in Seattle, WA. The author of more than 30 books on health nutrition, Murray is also director of product science and innovation for Natural Factors Nutritional Products. For more information, visit www.doctormurray.com.

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