Statin Drugs: New Concerns and Alternative Therapies

New Concerns about Statin Drugs.
Should you consider non-drug alternative therapies?

The FDA recently raised additional safety concerns about statin drugs. They are going to require a warning that statin drugs can increase the risk of higher blood sugar levels and diabetes. In addition, the FDA said labels for statin drugs will now caution that some patients might experience memory loss and confusion.

We already knew that there were potential hazards associated with statin drugs. This is no surprise, as all drugs have side effects. We need to evaluate whether or not the benefits outweight those risks. Some of the side effects previously associated with statin drugs are the following:

- Liver damage
- Muscle and joint aches
- Nausea
- Diarrhea
- Constipation

At the same time the FDA announced the new concerns (blood sugar, memory loss and confusion), they announced that drug makers could remove a label warning that liver enzymes need to be monitored during statin therapy. They cited the fact that “serious liver injury with statins is rare and unpredictable” and that periodic monitoring “does not appear to be effective in detecting or preventing this rare side effect.”

That’s interesting. They are not saying the danger is any less. They are just saying there is no way to detect or prevent it. I don’t find that overly reassuring.

If you are taking a statin, such as Crestor, Lipitor (atorvastatin in its generic version) or Zocor (simvastatin), what should you do? According to most cardiologists, if you are in the “high-risk” category, i.e. someone who has already had a “cardiac event,” the benefit still outweighs the risk. “The vast majority of patients—especially those who are clearly at high risk of a heart attack—should keep taking the medicines, according to several cardiologists.”

Less clear is the advice for people who haven’t had a heart attack but have multiple risk factors, such as high blood pressure, high cholesterol, smoking history and perhaps a family history. Many doctors consider this as high risk as well. I think this is a group that has some serious thinking to do.

“For anyone with moderate or low risk, a decision to start or stay on a statin should be subject to individual belief and judgment and a discussion with a physician. If you’re on the fence and aren’t confident that a statin is called for, these new FDA warnings might give you cause to learn more about your risk before deciding what course to take.

If you are experiencing any of the known side effects, including these new ones, it is definitely time for a consultation with your doctor. “If someone isn’t thinking right, they definitely should stop taking their medicines and see if it gets better.” The effects on blood-sugar levels are also reversible in a vast majority of cases. (WSJ. Dow Jones & Company, Inc 2012)

If you are experiencing any of these side effects, or if you decide that in your case the risk to benefit analysis points in a non-drug solution, there are many effective options available to you. I will present those in a moment. First, let’s look as some additional comments about the statin drugs in general.

Michael Murray, N.D., in his recent book “What the Drug Companies Won’t Tell You and Your Doctor Doesn’t Know,” Atria Books, 2009, makes the following points about statin drugs in the chapter titled “Exploiting The Cholesterol Myth.”

“The cholesteerol-lowering statin drugs are anotheer example of ho the drug industry uses its muscle to peddle a products. There drugs are sold primarily on the premise that they will save lives by lowering cholesterol levels, but in reality they have not convincingly demonstrated an ability to extend life in women, and they produce very little effect in men who show no clinical evidence of heart disease. Also, statins involve a significant risk of serious side effects. It is a one-sided situation: the drugs provide no real benefit to the person taking them, but they are a very important source of revenue for the drug companies. Annual sales of these drugs now exceed $25 billion. They generate huge profits for the drug companies. The statin “empire” is perhaps the greatest accomplishment of the modern drug industry, and this is an achievement the drug companies and doctors should be ashamed of.

“The only reason we are so fixated on cholesterol is the influence of the pharmaceutical industry. It is very interesting to note that more than half the people who die of a heart attack or a stroke have low to normal cholesterol levels. How do the drug companies and the government respond to this fact? They simply recommend making the suggested target cholesterol levels even lower, thereby effectively casting an ever wider net for potential customers. Their goal is to turn all of us into patients hooked on statins. It i8s also very interesting that six of the nine expert members of the government panel that drafted the new cholesterol guidelines had either received grantsw from or were paid consulting or speakers’ fees by the companies that make some of the most popular statin drugs. There may be a conflict of interest here, but in any case these new guidelines should dramactically increase the number of patients on statin drugs. Keep in mind that statins are already the biggest moneymakers in the drug industry.

“Although high cholesterol levels are associated with an increased risk of a heart attack or stroke, the relationship of cholesterol to these cardiovascular diseases (CVDs) is much more complex than the drug companies and many doctors portray it. According to conventional wisdom, lowering cholesterol with statin drugs should decrease the risk of CVD. But except for those taking statins because of a prior heart attack or another significant risk factor, the science simply does not support this assumption. . .”=-0.0
For those of you who are interested in learning more about statins, controlling cholesterol, and alternatives to drugs, I highly recommend the following two books:

What The Drug Companies Won’t Tell You, And Your Doctor Doesn’t Know (The Alternative Treatments That May Change Your Life–And the Prescriptions That Could Harm You). Michael Murray, N.D. Atria Books, 2009. Willner Code: 57314 (List: $25; Willner Price: $20)

What You Must Know About Statin Drugs & Their Natural Alternatives (A Consumers’s Guide to Safely Using Lipitor, Zocor, Mevacor, Crestor, Pravachol, or Natural Alternatives.) Jay S. Cohen, MD. Square One Pub, 2005. Willner Code: 50734 (List: $15.95; Willner Price: $12.76)

As Dr. Murray says, cardiovascular disease is a multifactorial issue, and any attempt to simplify it by addressing only one risk factor is doomed to fail. “Simply stated, there are more important things to consider than the level of LDL cholesterol. The whole premise of reducing LDL cholesterol levels with statins is the mistaken belief that this will reduce the buildup of arterial plaque,” but researchers at Beth Israel Medical Center in New York City demonstrated that the statin-induced reduction of cholesterol “didn’t appear to have any statistical effect on the buildup of plaque. In other words, the buildup of plaque (which is the reason why doctors try to lower cholesterol) didn’t appear to be related to cholesterol levels. Again, there are other factors involved in the process of atherosclerosis that are significantly more important than lowering cholesterol, but are largely ignored because they do not involve drug therapy.”

What are those other factors?

Dietary measures can make a difference. Reduce your saturated fat, trans fatty acid, cholesterol and total fat in your diet by eating less meat and dairy, and more plant foods. Increase your intake of omega-3 fats and monounsaturated fats (cold water fish, nuts, olive oil, etc). Increase your intake of fruits and vegetables. Increase your fiber intake, especially “water-soluble” fiber (psyllium, oat, gums, etc). And limit your intake of refined grains and sugar (simple carbs).

Other lifestyle changes are important. Stop smoking. Lose weight. Exercise.

And take nutritional supplements. Here is a list of supplements of specific interest to those with cardiovascular concerns.

- Multivitamin Multimineral Supplement. Taking some type of “eye” or “vision” formula without also taking a good, balanced, full spectrum multivitamin multimineral supplement is a big mistake. Always take a good multi, as the foundation of your regimen. Make sure you include adequate calcium and magnesium. If you take a one-per-day or two-per-day formula, you will need a separate calcium/magnesium product.

Willvite, by Willner Chemists
120 Tablets – Code: 30439

- Niacin. Niacin is one of the B-Vitamins (B3). It has many functions. It is necessary for the processing of carbohydrates into energy or fat, for example. Niacin also plays a role in the metabolism of cholesterol. At high dosages, niacin acts more like a drug than a vitamin. It reduces total cholesterol and LDL-cholesterol, while raising the good HDL-cholesterol. Niacin also has beneficial action on triglycerides and fibrinogen levels. Most important, perhaps, is that some studies have indicated that niacin reduces people’s risk of heart attacks, including the risk of recurrent heart attacks in cardiac patients, and overall mortality.

What is the down side? At the high dosage needed to lower cholesterol, niacin can cause an unpleasant, although transient, flushing of the skin. The dose in this case can be several grams a day. It is important to note, by the way, that niacinamide, another form of vitamin B3, does not cause this flushing. Unfortunately, it also does not lower cholesterol.

There are three options available to those who want to utilize niacin, perhaps the best anti-cholesterol agent available. First, some people can tolerate regular niacin. Various methods of minimizing the flushing discomfort have been suggested. Second, there is a “intermediate-acting” form of niacin, Niaspan, available on prescription, that is effective in lowering cholesterol and less likely to cause the skin flush. Third, there is a non-prescription alternative, often referred to as “No-Flush Niacin.” It is actually a form of niacin called Inositol Hexaniacinate or Hexanicotinate. It is very popular with alternative physicians, and effective in dosages as low as 600 mg twice daily. It is commonly used at dosages of 500 to 1000 mg, two to three times daily. It has been used at levels as high as four grams daily, with no adverse reactions.

Used in this way, any of the above forms of niacin require monitoring by your physician, checking liver enzymes, uric acid, and glucose levels.

No Flush Niacin, 500 mg, by Solgar
Code: 13148 – 100 Capsules
Code 24663 – 250 Capsules

No Flush Niacin, 800 mg, by Twinlab
Code: 21105 – 50 Capsules

Niacitol No Flush Niacin, 725 mg, by Pure Encapsulations
Code 51737 – 90 VeggiCaps

- Fish Oil. According to Dr. Michael Murray, “Of all the nutritional products that can help prevent Cardiovascular Disease, the most important, without question, is pharmaceutical-grade fish oil.” In his book, Dr. Jay Cohen says “Omega-3 fatty acids (EPA and DHA may be as important as any of the pharmaceuticals and nutriceuticals discussed in this book.”

Dr. Cohen goes on to point out that, “today, it is widely accepted that omega-3 fatty acids reduce heart attacks, strokes, and deaths from heart disease, as well as the overall incidence of death from all causes. . . we also know that omega-3 oils are a critical factor in keeping blood vessels functioning properly and in preventing cardiac arrhythmias when heart attacks occur. For many people, the first symptom of heart disease is a heart attack. Each year, 250,000 people die from sudden cardiac death, usuall from heart attacks that are not in themselves lethal, but which trigger arrythmias that are. Multiple studies have now proven that omega-3 oils reduce the risk of sudden cardiac death by an astonding 40 percent to 80 percent.” According to Dr. Christine M. Albert, the chief of cardiology at Massachuysets General Hospital and the lead author of a major study on this issue, “The higher your blood level of omega-3, the lower your risk” of sudden cardiac death.

I invited Dr. Michael Murray to elaborate on his comments about the importance of omega-3 fish oil supplements, and he responded with the following:

“When your cardiovascular system works well, every other part of your body – including your brain – functions better. Consider that in an average lifetime, the heart will beat 2.5 billion times and pump one hundred trillion gallons of blood and you will start to recognize why it is so important to do everything you can to support your heart.

“One of the key effects of fish oils is supporting healthy vascular tissues. Maintaining the health of our arteries requires that platelets continue functioning properly. These blood cells can become very sticky and form blood clots. A high intake of saturated fat is one factor that contributes to platelet stickiness, and so leading to hardening of the arteries. The good news is that fish oil has been shown by many medical studies to reduce platelet stickiness. This action is thought to be a major factor in maintaining healthy cardiovascular functions. Regular consumption of fish oil supplements has also been shown to support healthy blood triglyceride levels, blood pressure and improve blood flow. These effects are all significant goals for supporting a healthy heart.

One of the most important steps to ensure heart health is to take a fish oil supplement. However, not all fish oil is alike. One of the best fish oil supplements available is Rx Omega-3 Factors™. It is referred to as a “pharmaceutical grade” fish oil because it possesses the following characteristics:

- It is manufactured in a certified GMP facility approved for pharmaceutical products.
- It is manufactured according to pharmaceutical standards that include quality control steps to insure the product is free from lipid peroxides, heavy metals, environmental contaminants and other harmful compounds.

For general health, the suggested usage is 1,000-1,200 mg of the long-chain omega-3 fatty acids EPA and DHA (combined amount) daily.

(Dr. Murray, in conjunction with Natural Factors, has developed the following two omega-3 fish oil supplements:)

RxOmega-3 Factors: Ultra Strength, by Natural Factors
(900 mg Omega-3 Fatty Acids per Softgel)
Code: 59107 – 150 Enteric Coated Softgels

RxOmega-3 Factors, by Natural Factors
(630 mg Omega-3 Fatty Acids per Softgel)
Code: 41830 – 120 Softgels

- Red Yeast Rice. This herbal supplement remains popular, even though the original product, Cholestin, as been taken off the market. The problem is that it’s effectiveness may be due to the fact that it naturally contains, to some extent, a substance similar to that found in the statin drug, lovastatin. If this is the case, it might be expected to exhibit the same side effects, etc, as the drug. The red yeast rice products that remain on the market are said to contain lower amounts (naturally occuring) than was present in Cholestin. Reputable brands assure us that there products are citrinin-free. Citrinin is a potentially toxic fermentation product. Those physicians and nutritionists who recommend red yeast rice claim that it works, and is remarkable side-effect free. They feel that there are other naturally occuring cholesterol-lowering compounds in the product that synergistically combine to explain its efficacy. This may indeed be true.

Red Yeast Rice, Heartsure, 600 mg, by Nature’s Way
Code: 56501 – 120 VeggieCaps

Red Yeast Rice, 600 mg, with CoQ10, by Nature’s Way
Code: 56505 – 60 VeggieCaps

Red Yeast Rice, 600 mg, with Phytosterols, by Nature’s Way
Code: 56504 – 60 Tablets

Red Yeast Rice, 600 mg, by Doctor’s Best
Code: 42861 – 120 Veggie Caps

Red Yeast Rice 600 mg Plus CoQ10 50 mg, by Jarrow Formulas
Code: 58831 – 120 Capsules

Red Yeast Rice – Rice that has been fermented by the yeast Monascus purpureus has been used in Asia for centuries as a food preservative, food colorant and flavoring as well as in traditional herbal formulas. It is part of the diet in China, Japan, and Asian communities in the United States. Jarrow FORMULAS® uses Red Yeast Rice that is carefully fermented to avoid the presence of the natural byproduct citrinin. Coenzyme Q10 complements Red Yeast Rice in supporting healthy cardiovascular function.

- Beta-Glucan. Beta-glucan is a soluble fiber derived from the cell walls of algae, bacteria, fungi, yeast, and plants. The beta-glucan found in yeast and mushrooms contain 1,3-glucan linkages and occasionally 1,6 linkages, whereas the beta-glucans from grains (i.e., oats and barley) contain 1,3 and 1,4 linkages.

If you look for “Beta Glucan” supplements, you will find products that are designed for immune system support, not cholesterol reduction. To get the benefits of beta glucan’s cholesterol lowering action, you want to look for fiber products, such as oat bran.

Oat Bran 750 mg, by Solgar
Code: 13483 – 100 Tablets
Code 13484 – 250 Tablets

- Fiber Supplements. Other fibers, beside oat bran, have been shown to lower cholesterol and LDL cholesterol. Psyllium, and other “water-soluble” fibers, gums, pectins, etc have this effect.

Soluble Fiber Formula, by Yerba Prima
Code: 12121 – 12 Ounces (Powder)
Code: 12120 – 180 Capsules

Fiber Formula: Oat Bran and Psyllium, by Integrative Therapeutics
Code: 54278 – 120 Capsules

Gentle Fibers, by Jarrow Formulas
Code: 24810 – One Pound (Powder)

- Plant Sterols, Beta-sitosterol. Sterols are essential components of the cell membrane in both animals and plants. Cholesterol is a sterol found in humans. In plants, the sterols are different. Beta-sitosterol is a plant sterol. When humans eat plant sterols and stanols, these substances block the absorption of cholesterol from the intestine. According to National Standard, “Many studies in humans and animals have demonstrated that supplementation of beta-sitosterol into the diet decreases total serum cholesterol as well as low-density lipoprotein (LDL) cholesterol and may be of benefit for patients with hypercholesterolemia (high levels of blood cholesterol).”

Cholesterol Formula with Sytrinol, by Natural Factors
Code: 51368 – 120 Capsules
“Combining plant sterols with Sytrinol provides a comprehensive formula that addresses all facets of dyslipidemia including high cholesterol, high LDL and high triglycerides.”

Beta Sitosterol Mega Strength, by Source Naturals
Code: 51407 – 120 Tablets

Phytosterols are natural components of many vegetables and grains. Preliminary scientific evidence suggests that plant phytosterols may help to support cholesterol wellness when consumed as part of a low cholesterol dietary program. The three main phytosterols in phytosterol complex are beta-sitosterol, campesterol, and stigmasterol. They are natural, safe, and derived entirely from plant sources.

Beta Sitosterol Phytosterol Complex, by Source Naturals
Code: 37519 – 180 Tablets

- Garlic. Listen to the recent interview with James LaValle, R.Ph., N.D. on The Willner Window, airing February 26, 2012, for the latest research demonstrating the role that garlic (aged garlic, in this case) can play on cholesterol and cardiovascular health. Go to http://www.willner.com and click on the radio tab.

Kyolic Aged Garlic Extract, Formula 107, by Wakunaga
Aged Garlic and Phytosterols Combination
Code: 44845 – 80 Capsules

Kyolic Reserve 600 mg Cardiovascular, by Wakunaga
Code: 22121 – 60 Capsules
Code: 25640 – 120 Capsules

Kyolic One Per Day 1000 mg, by Wakunaga
Code: 44680 – 30 Caplets

This is not a complete list of supplements that can be an effective part of a cholesterol lowering, heart healthy supplement program. Some of the other supplements that should be considered are the following:

- Pantethine (vitamin B5)
- Vitamin C
- Chromium
- Soy
- Calcium, Magnesium
- Gum Guggle
- L-carnitine
- tocotrienols
- policosanol, octacosanol
- CoQ10, Ubiquinol

In summary, if you are unsure if you should rely on statin drugs, or if you should continue doing so, you do have other options. Effective options. In some cases, availing yourself of these options may allow you to lower your dose of statin drug, if not eliminate it altogether. It is important, however, to work with your physician if you intend to make these changes. A conscientious physician should be happy to work with a patient who wants to substitute dietary changes, lifestyle modification and a therapeutic supplement regimen for prescription drugs.

Don Goldberg, R.Ph.

Note: If you want to order or inquire about the various products mentioned, use the “code number” to easily identify the product. This is true whether your are on the Willner website, or calling the store directly.

About Don Goldberg

Hello. I am what you might call a Nutritional Pharmacist. After college, I worked in the Pharmaceutical and Nutritional Industry, first in Quality Control, and then in Manufacturing and Product Development. Increasingly, as the years passed, I became more involved with nutritional supplements. I spent many years detailing physicians, herbalists, and homeopaths about nutritional and herbal therapies and products. In 1992, along with my friend Arnie Gitomer, I bought Willner Chemists, a well-established nutritionally oriented pharmacy. For the first time, I had an opportunity to communicate directly with the consumer, the patient, and the customer. I love it. This blog is an additional way for me to extend my personal views and opinions directly to you. You can also hear me on the radio, every Sunday, from 2 to 4 pm on WOR radio in NY (710 AM), or WGKA in Atlanta (920 AM). Or check our website, www.willner.com.
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5 Responses to Statin Drugs: New Concerns and Alternative Therapies

  1. Steve says:

    where will i buy this

    • Don Goldberg says:

      Steve, if you are asking about the various supplements mentioned in the latter part of the article, they are all available at Willner Chemists, in New York. The toll free number is 800-633-1106 and the website is http://www.willner.com. Most of the items are also available in health food stores, but Willner’s prices are as good as you will find. In most cases, the item numbers are those used by Willner Chemists.
      After the article was written, for your information, there has been one study published questioning the value of niacin.
      Don Goldberg

  2. What’s Taking place i am new to this, I stumbled upon this I have discovered It positively helpful and it has aided me out loads. I’m hoping to give a
    contribution & help different users like its aided me.
    Great job.

  3. Zelda says:

    I think what you posted made a great deal of sense. However,
    what about this? suppose you wrote a catchier post title?
    I mean, I don’t wish to tell you how to run your website, however suppose you added something to maybe grab folk’s attention?
    I mean Statin Drugs: New Concerns and Alternative Therapies |
    Don Goldberg’s Blog is kinda plain. You could glance at Yahoo’s home page and note how they write post titles to grab people to click.
    You might add a related video or a related picture or two to grab
    readers excited about everything’ve written. Just my opinion, it would make your posts a little livelier.

    • Don Goldberg says:

      Thanks for your comment. Actually, it is very appropriate. Now that we are no longer doing the radio show, I am trying to focus on enhancing our email newsletter, and setting up a presence on Facebook, Twitter, etc. This is new to me, so I welcome any advice. Also, I urge everyone to sign up for our email newsletter. Go to http://www.willner.com/subscribe.aspx
      Don Goldberg

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