New FDA warnings on statins; NYBC reviews supplements to support cardiovascular health

In February 2012 the FDA added new safety warnings about statins, the cholesterol-lowering medications that are among the most widely prescribed drugs in the world. The side effects cited by the FDA include memory loss, muscle pain (myopathy), and now a significant diabetes risk as well. Reports of memory loss, confusion, and forgetfulness were found in all types of patients taking statins, according to the new warnings.

In addition, a 2011 review in the Cleveland Clinic Journal of Medicine concluded that statin-related muscle pain was much more common than previously reported. (The main reason: clinical trials of statins often eliminated patients more likely to develop muscle pain as a side effect of the medication.) The same article estimated that muscle pain as a side effect may help explain why up to 25% of adults stop taking statins within six months, and up to 60% stop taking them within two years.

There is good evidence that statins can be valuable in preventing heart disease, and there is widespread consensus that they remain a crucial option for many dealing with cardiovascular disease and risk. However, it’s also more evident than ever that statin side effects are significant. And given the side effects, there is some disagreement among doctors about what cholesterol levels should call for treatment with statins, and what levels can better be dealt with through changes in diet or exercise habits.

It’s a complex subject and of course involves many individual factors including age, family history and blood pressure, so, as you’d expect, NYBC advocates that everyone make decisions about how best to manage cardiovascular risk and disease in consultation with their healthcare provider.

Given the new FDA warnings about statins, NYBC also believes that it’s more important than ever for people to be aware of the potential of dietary supplements in supporting cardiovascular health. Here are some of the supplements we often recommend for consideration:

–Plant products called sterols have been shown to inhibit cholesterol. See, for example, Douglas Labs’ Cardio-Edge.

Fish oil (omega-3 fatty acids). Research has found a strong effect on lowering triglycerides, one measure associated with cardiovascular risk. Recommended to support cardiovascular health by the American Heart Association.

Flaxseed: 40-50 grams per day can have a substantial impact on cholesterol.

Pomegranate concentrate. Needs more study, though recent research found that diabetic patients taking pomegranate concentrate were able to lower their cholesterol significantly.

Finally, if you are taking statins, consider supplementing to lessen the risk of certain side effects. A 2011 research report suggested that Vitamin D deficiency might contribute to muscle pain caused as a side effect of statins, and that supplementing with the sunshine vitamin could reverse that side effect. (Reference: Glueck, C J et al. Curr Med Res Opin. (2011 Sep). “Vitamin D deficiency, myositis-myalgia, and reversible statin intolerance”) Also, a 2007 pilot study suggested that the supplement CoQ10, used to support cardiovascular health in a variety of contexts, could diminish statin-related myopathy and improve a person’s ability to continue normal daily activities. (Reference: Caso, Giuseppe. Am J Cardiol. 2007 May 15. “Effect of coenzyme q10 on myopathic symptoms in patients treated with statins”)

For more on Vitamin D and CoQ10 see the NYBC entries:


Vitamin D3


Omega-3 fatty acids for diabetes

The American Diabetes Association magazine Diabetes Forecast has a good discussion on the value of omega-3 fatty acids (including fish oil supplements) and their significance for people with diabetes, or at risk for developing diabetes. The September 2010 issue of this ADA magazine, for example, reports on a study showing that omega-3 fatty acid supplements boosted heart health in people with Type 2 diabetes. After a year of monitoring, it was found that a group of people with Type 2 diabetes who took the supplements had significantly less development of atherosclerosis (plaque buildup in the arteries that can lead to heart attack or stroke) than the control group that didn’t take the omega-3s.

The next question is how to get these beneficial omega-3 fatty acids effectively. Here’s an excerpt from the Diabetes Forecast magazine recommendations. This covers the dietary sources of omega-3s, and also gives good advice about how to use supplements:

All omega-3s aren’t created equal, so knowing the type you’re getting is important. The most potent omega-3s are EPA and DHA; that’s why your best bet is to eat plenty of oily fish like salmon, herring, and halibut. […]

If you are allergic to fish, are a vegetarian, or just can’t stomach the taste, you can still add omega-3 to your diet by eating plant-based ALA-rich foods–you’ll just have to eat more to get the same amount of EPA and DHA you’d get from fish because some omega-3s are lost as the body converts ALA to EPA and DHA. Good sources of ALA include flax seed oil and flax meal, walnuts and walnut oil, pecans, olive oil, and canola oil. “The flax meal is one of the easiest things to use. It has a very nice, nutty flavor,” says Susan Mitchell, PhD, RD, a registered dietitian, nutrition consultant, and coauthor of Fat Is Not Your Fate. She recommends adding flax to smoothies, yogurt, and oatmeal, or drizzling walnut oil over salads.

Another way to get the essential fatty acids is by eating omega-3-enriched foods. “You have to do just a little more homework,” says Mitchell, who recommends checking a product’s packaging for sources of omega-3 (some may list DHA-rich algae oil in the ingredients). Simopoulos says omega-3-enriched eggs also provide a good amount of EPA and ALA. Or try hemp-fortified foods (such as certain cereals); according to Evelyn Tribole, MS, RD, a registered dietitian with a private practice in Newport Beach, Calif., and author of the Ultimate Omega-3 Diet, they contain stearidonic acid, which helps increase the concentration of EPA in the body.

If you can’t get enough omega-3 from your diet, consider taking a supplement. […] One option for those who do not eat fish is a DHA-enriched algae supplement, but otherwise fish oil is the ideal choice. Even those who are allergic to fish can take a fish oil supplement, says Simopoulos. That’s because fish oil supplements don’t contain the proteins that cause an allergic reaction. Fish oil supplements don’t have any side effects–though some people complain about an aftertaste or fishy-tasting burps. (You can try taking your supplement before a meal to prevent this.)

Note–NYBC stocks Max DHA – Omega-3 Fish Oil(Jarrow) and Pro Omega – Nordic Naturals Fish Oil. See product entries for more infomration on suggested usage.

Flaxseed as a dietary supplement: A review from the Wake Forest Center for Botanical Lipids

We recently took a look at The Wake Forest University Center for Botanical Lipids website. This Center is one of five such dietary supplement research centers funded through the federal government’s National Institutes of Health–so this website represents our tax dollars at work!

The main goal of this new research center is to “determine the role of fatty acid based dietary supplements in the prevention and treatment of chronic human diseases associated with inflammation.” The center’s website also makes the point that “nearly 20% of Americans use dietary supplements, many of them botanicals, but scientific evidence for their safe and effective use in the prevention or treatment of human diseases has lagged behind the use of the products.”

Actually, we think the 20% estimate may be on the low side, especially if you include use of basic multivitamins; and certainly among groups with chronic conditions (such as osteoarthritis) the rate of supplement use is often higher than 20%. But we certainly agree that we need more scientific evidence about the effectiveness and safety of supplements, and we’re glad to know that the NIH has continued to fund such research, especially through its National Center for Complementary and Alternative Medicine (NCCAM) and its Office of Dietary Supplements (ODS).

OK, enough of the federal governmental acronyms, and back to the Wake Forest website. We’re pleased to see that it includes a user-friendly section with some publications easily understood by the general public (“Articles for Everyday People”). Here’s a sample from the piece entitled “The Use of Dietary Flaxseed for the Prevention of Human Disease”:

Flaxseed (also called linseed) has been a part of the human and animal diet for thousands of years. It is the richest known plant source of omega-3 fatty acids – 58% of the total fat in flax is composed of alpha-linolenic acid (LNA); however, this fatty acid is a short chain omega-3 as opposed to the long chain omega 3s found in fish oil. A number of studies have shown that flaxseed does not replace fish oil in the diet because the conversion of LNA to the omega-3 fatty acids found in fish oil is very inefficient.

Flaxseed is also a minor source of the omega-6 fatty acid linoleic acid (LA), which makes up about 14% of the total fat content. LNA and LA are essential fatty acids, meaning they cannot be made in the body and instead must be present in the diet. LNA is thought to be necessary for the proper function of cell membranes and nerve cells. In addition to LNA, flaxseed also contains soluble and insoluble fiber and lignans, which are antioxidants and estrogen precursors called phytoestrogens.

Flaxseed provides a healthy balance of omega-3 and omega-6 fatty acids, which is thought to have beneficial effects on many diseases, especially those with a strong inflammatory component, such as inflammatory bowel disease, arthritis, asthma, gout, and lupus. Flaxseed oil has been used to treat burns, acne, eczema, rosacea, and other skin disorders, and it promotes healthy hair and nails. Flaxseed has been suggested to minimize nerve damage in degenerative diseases such as Parkinson’s disease and may guard against the effects of aging.

The lignans in flaxseed may also play a role in cancer treatment and prevention, especially in women with breast cancer. The phytoestrogens found in flaxseed are thought to act as “designer estrogens” and are a good supplement to regular therapy (1). In a study of women with breast cancer, those who consumed 25 grams of flaxseed oil per day saw a reduction in tumor growth compared to placebo controls (2). The LNA in flaxseed may decrease the risk of sudden cardiac death by stabilizing the electrical system of the heart and preventing potentially fatal irregularities in heart rhythm. In a study of more than 75,000 women, those who consumed more than 1.5 grams of flaxseed per day had a 46% lower risk of cardiac death than women who consumed less than 0.5 grams per day (3).

While most studies show a benefit of flaxseed oil, there have been studies which have not been positive. In 5 out of 6 epidemiological studies on prostate cancer, flaxseed was shown to increase cancer risk, and LNA is a strong growth stimulus in isolated prostate cancer cells (4). Neither of these effects has been seen with fish oil. In addition, recent studies suggest that flaxseed may increase the risk of macular degeneration or speed up the progression of the disease.

In a nutshell: flaxseed looks to be very interesting for breast cancer and cardiovascular disease, but not recommended when prostate cancer or prostate cancer risk is present.