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:

CoQ10

Vitamin D3

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Changing diet reduces risk of dyslipidemia (abnormal blood fats) in people with HIV starting antiretroviral treatment

Switching to a diet that concentrates on fruits, vegetables, nuts and whole grains was found in a recent study to very significantly reduce the risk of people with HIV developing dyslipidemia when they started antiretroviral treatment. Dyslipidemia is an abnormal amount of fats (such as cholesterol) in the blood. It is generally associated with an increase in risk of cardiovascular disease. Dyslipidemia is one of the side effects frequently found with HIV drugs (protease-inhibitors and nonnucleoside-reverse-transcriptase inhibitors).

The study followed two groups of HIV+ people who were beginning antiretroviral therapy: one group switched to the high-fiber, low-fat diet, and the other group did not. After one year, 68% of the group that did not change its diet had developed dyslipidemia, while only 21% of the group that changed its diet had.

The study was reported in the Journal of the American College of Cardiology, and was accompanied by an editorial that commented:

“it is likely that patients living with HIV infection who do not eat too much (ie, calorie restriction) and who eat fruits, vegetables, nuts, and whole grains (ie, high-fiber, low-cholesterol, and low-fat foods that keep the ‘bowels soft’) will benefit by avoiding illness and improving quality of life […]For patients living with HIV infection, avoiding dyslipidemia also avoids, or at least delays, use of lipid-lowering medications [such as statins], which are expensive and are complicated to use in patients on HAART.”

Quite a lot of advantages!

References:

1. Lazzarretti RK, Kuhmmer R, Sprinz E, et al. Dietary intervention prevents dyslipidemia associated with highly active antiretroviral therapy in human immunodeficiency virus type 1-infected individuals. J Am Coll Cardiol 2012; 59:979-988.
2. Stein JH. Nutritional intervention to prevent dyslipidemia in patients starting antiretroviral therapy for human immunodeficiency virus. J Am Coll Cardiol 2012; 59:989-990.

CoQ10 with statins

Researchers studying the effects of the cholesterol-lowering statin drugs over the last decade found that patients taking statins were likely to also have lowered levels of coenzyme Q10 (CoQ10), a coenzyme naturally produced in the body and important to the function of organs such as the heart. Further study has also indicated that supplementing with CoQ10 while taking statins can reverse the deficiency and limit the side effects.

A few facts and recommendations about CoQ10:

CoQ10 functions inside cells to make energy; the highest amounts of the coenzyme are found in the heart, liver, kidneys and pancreas. The muscles of the heart are especially sensitive to CoQ10 deficiency.

Statins act by inhibiting an enzyme, HMG-CoA reductase, that is responsible for synthesizing both cholesterol and CoQ10. So statins seem to simultaneously decrease cholesterol and CoQ10 levels.

A 2004 report in the American Journal of Cardiology found that 70% of people in a study group taking the statin Lipitor showed heart muscle weakness after six months. This weakness was reversed by taking CoQ10.

CoQ10 has also been studied for these statin side effects: muscle pain and weakness, fatigue, memory loss, shortness of breath and peripheral neuropathy.

A common recommendation for those taking a statin: supplement with 100 mg CoQ10 softgel twice daily, in the morning and at noon. Avoid insomnia by taking it early in the day. Be sure to consult your doctor about the possibility of CoQ10 interacting with any blood thinner you may be taking.

Reference: Marc Silver et al. Effect of atorvastatin on left ventricular diastolic function and ability of coenzyme Q10 to reverse that dysfunction. American Journal of Cardiology. Volume 94, Issue 10 , Pages 1306-1310, 15 November 2004.

See the NYBC entries for more details:

http://nybcsecure.org/product_info.php?cPath=47&products_id=317
(Jarrow 100mg CoQ10 Qsorb)

or

http://nybcsecure.org/product_info.php?cPath=47&products_id=357(Douglas Labs 200mg chewable tablet formula)

Cholesterol-lowering dietary supplements: views from the Mayo Clinic

NOTE: The Mayo Clinic has updated some of its recommendations on cholesterol-lowering supplements. See our Blog post at

http://wp.me/p7pqN-sb

The Mayo Clinic has posted on its website an interesting podcast entitled “Cholesterol-lowering supplements: which work and which don’t.” This broadcast interview features the views of Dr. Brent Bauer, director of the Complementary and Integrated Medicine Program at Mayo Clinic.

Here are some of the highlights from the podcast:

–Plant sterols, particularly beta-sitosterol and sitostanol. These plant products act much like cholesterol and can reduce the absorption of cholesterol. Can be found in margarine or spreads. (Also included in some supplements, such as Douglas Labs’ Cardio-Edge.)

–Fish oil (omega-3 fatty acids). Strong effect on lowering triglycerides, one measure associated with cardiovascular risk.

–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.

–Policosanol, a waxy residue from sugar cane. Much positive data from Cuban researchers a few years ago, but no one outside Cuba has been able to replicate these studies, so there is now a great deal of skepticism about its effectiveness.

— Garlic. Once regarded as interesting for reducing cholesterol, but subsequent studies have shown its value to be very limited.

–Dr. Bauer has some good advice concerning mixing supplements and prescription drugs: “whenever you mix a dietary supplement and a medication, there’s always potential for interactions, what we call drug-herb interactions, so we’re very cautious about doing that. The one exception in this realm would be using one of those plant sterols that we talked about earlier — beta-sitosterol or sitostanol. Those have been studied in conjunction with statin medications, and what those studies show is that you can achieve further reduction, beyond what you’ve got just with the statin medication, by adding one of those plant sterols to your regimen.” We would also add that, among the dietary supplements, niacin has also been studied in conjunction with statins as a means to manage cholesterol. (Niacin is especially noteworthy in that it can help to raise levels of HDL (“good cholesterol”), which, in more recent years, has come to be seen as an important part of reducing cardiovascular risk.)

Listen to the Mayo Clinic podcast at

http://www.mayoclinic.com/health/cholesterol-lowering/CL00038

CoQ10 – 200mg

NYBC has recently decided to stock CoQ10 in a 200mg/capsule format (Jarrow)</, since many research studies involve supplementation at that daily level or even higher. As a not-for-profit purchasing co-op, NYBC seeks low-cost options for people choosing to use supplements, so this format from the well-regarded Jarrow line seemed a good value as well.

An extract from the NYBC write-up on this supplement–

Clinical studies have shown repeatedly that coenzyme Q10 has potent abilities to assist the heart muscle, and as an adjunct treatment for angina, congestive heart failure, arrhythmia, hypertension (high blood pressure), and drug toxicity.

Research has also shown that as cellular levels of coenzyme Q10 decrease, HIV disease progresses. Other studies have documented its immune restorative qualities, including restoration of T cell function. Absorption of dietary fat soluble coenzyme Q10, due to the high inflammatory cytokine levels, is disrupted, so supplementation may help. Many PWHIV believe CoQ10 is an important nutrient to aid in detoxification if one uses nucleoside analogues (AZT ddI, ddC, d4T, etc.) or any toxic drug. Due to this impaired absorption, it’s best to take a form of CoQ10 that is mixed with lecithin or some other fat to improve its uptake. However, it may be that only very high doses will help (like 200-400 mg a day!) This will not be cheap.

CoQ10 is very helpful in conjunction with certain drugs. Studies have shown clear benefit when used with a heart toxic chemotherapy drug called adriamycin. In addition, some have suggested that it is very important to use CoQ10 when taking one of the statin drugs, used to manage high LDL cholesterol since the level of CoQ10 in the blood is depleted when using this class of drugs.

Nutritional supplements to reduce cardiovascular risk

Here’s an excerpt from the Fall 2008 issue of the New York Buyers’ Club SUPPLEMENT . (You can read the full issue online at http://www.newyorkbuyersclub.org/supplement/, where you’ll also find an archive of past numbers.)

It’s all about managing risk.

People try to control risk all the time, whether it’s kids learning to cross the street on green, people buckling their seat belts when getting into the car, or a smoker looking at the statistics relating tobacco use to cancer and heart disease and deciding that now is the time to quit.

Earlier this year, a group of experts on HIV and heart disease recommended that people with HIV pay special attention to monitoring and controlling cardiovascular risk factors like high cholesterol and diabetes. Overall, according to currently available evidence, the risk of heart attack is approximately 70% to 80% higher for HIV-positive people than for HIV-negative people. This increased level of risk is likely due in part to HIV itself, and in part to HIV medications. Some typical cardiovascular warning signs for people with HIV include reduced levels of HDL (“good cholesterol”) and high triglycerides, or a tendency toward pre-diabetes. The panel of experts, which was convened by the American Heart Association and the American Academy of HIV Medicine, found indications that even HIV+ children on meds have early development of these kinds of cardiovascular risk factors.

You may also have heard recent news stories about the HIV medication abacavir and elevated risk of heart attack. A commonly used HIV med in the family of drugs called nucleoside analogs (“nukes”), abacavir is part of the combination drugs Ziagen and Trizivir. Two studies based on large databases have detected an association between abacavir and increased risk of heart attack. Although there isn’t an exact understanding of how abacavir (or another nuke, ddI) could cause higher risk of heart attack, the research does suggest that people with other cardiovascular risk factors, such as smoking or high cholesterol, are at the greatest risk.

Which brings us back to our original point: it’s all about managing risk—knowing the risk factors, then lowering them as much as you can. And that’s where nutritional supplements can be helpful.
At the top of the list of supplements to support cardiovascular health is fish oil, with its key component being the omega-3 fatty acids. Since 2005, the American Heart Association, following a hefty accumulation of scientific evidence, has recommended daily intake of fish oil for people with cardiovascular disease. And there has been research specifically looking at fish oil for people with HIV who have elevated cardiovascular risk. For example, a 2007 study of HIV+ people who had high triglyceride levels found that fish oil supplementation reduced these levels by 25% or more. Also of note: fish oil supplementation for people with HIV is being studied in federally funded research that examines how this supplement might counter the effects of lipodystrophy, a syndrome that includes blood lipid abnormalities.

People with HIV are often prescribed statin drugs like Lipitor to lower cholesterol and reduce cardiovascular risk, and while these drugs can be effective, they may also produce side effects, including joint and muscle pain and changes in mood and thinking ability. Many integrative health specialists endorse the idea of taking the supplement CoQ10 along with statins, since depletion of this nutrient by statins may be linked to some of the drug’s major side effects. Moreover, research suggests that, due to its antioxidant and blood-thinning properties, CoQ10 when combined with a statin decreases heart disease risk more than just the statin alone. Similarly, there is important research indicating that statins together with niacin can be more effective at reducing cardiovascular risk over the long term than just the statins. Though niacin dosage may have to be slowly increased in order to avoid “flushing” (redness, itchiness), strong scientific evidence for this supplement’s effectiveness and safety dates back to the 1970s, and indicates that it may be especially helpful in bringing up levels of HDL (“good cholesterol”), which is now regarded as a very significant marker for assessing cardiovascular risk.

A few months ago we were impressed by a talk given by Dr Jon Kaiser, an HIV physician with extensive experience in integrating nutrition and nutritional supplementation into his health care practice. While Dr. Kaiser ranged over several topics, including his well-known interest in the benefits of general micronutrient support for people with HIV, he also had much to say about controlling cholesterol levels with nutritional supplements. His approach consists of low-dose niacin (low dose to minimize flushing), fish oil, plant sterols and pantethine. As he’s started to follow case histories over the past few years, he’s become quite encouraged by the results, and believes that many people with HIV could achieve good results (comparable to those offered by statins, but without the side effects) by adopting this kind of combination therapy.

In the past year, NYBC has begun stocking a Douglas Labs product called CardioEdge, which, like Dr Kaiser’s approach, involves a combination of supplements (including plant sterols) to manage cholesterol. We’ve also recently added a Jarrow product, Pressure Optimizer, which combines several supplements (including theanine from green tea) that are useful in maintaining normal blood pressure. (High blood pressure is a major risk factor for cardiovascular disease, and it’s one of the first issues anyone should address in bringing down heart attack risk.)

We find that physicians who are knowledgeable about nutrition and nutritional supplements have a lot of useful advice to offer when it comes to controlling cardiovascular risk. For example, Dr Hyla Cass, author of the book Supplement Your Prescription: What Your Doctor Doesn’t Know About Nutrition (recently reviewed on the NYBC blog), calls attention to the fact that metformin, the most frequently prescribed diabetes drug in the US, depletes the B vitamins and thus can cause a spike in the body’s levels of homocysteine, a substance linked in recent research to high cardiovascular risk. To counter this danger, she emphasizes the need to supplement with B vitamins when taking metformin.

In line with much current scientific thinking, Dr Cass also believes that cholesterol level by itself is not an adequate measure for assessing cardiovascular risk. In addition, it’s necessary to look at underlying inflammatory processes in order to comprehend the threats to heart and circulatory system health. That’s why Dr. Cass recommends that people who want to reduce their risk of cardiovascular disease should develop a diet plan centering on anti-inflammatory nutrients. She suggests a diet high in antioxidant-rich foods—colorful fruits and vegetables, curry, rosemary, ginger, green tea, dark chocolate, and low-toxin fish like salmon or sardines. (Actually could make for quite a tasty menu, don’t you think?)

To conclude: yes, it’s sobering when researchers warn about increased cardiovascular risk for people with HIV. But there’s also general agreement that cardiovascular risk is very susceptible to management by choices in diet and nutrition. (Exercise and quitting smoking are also important!) So, while you can’t control everything in life, remember that there are many choices you can make to significantly reduce your cardiovascular risk.

Nutritional supplements discussed in this article: fish oil, CoQ10, niacin, plant sterols, pantethine, B vitamins; and the proprietary formulas CardioEdge and Pressure Optimizer.

Recommendations for Cardiovascular Health: from “Supplement Your Prescription,” by Hyla Cass, M.D.

We return to this excellent guide published in 2007 by Hyla Cass, a practicing physician and expert on integrative medicine.

In Chapter 4 of the book, Dr. Cass reviews recent findings that call into question the idea that dietary cholesterol causes cardiovascular disease. In line with the current scientific thinking on this subject, she suggests looking at underlying inflammation as essential to any understanding of risks to heart and circulatory system health. As a consequence, she says, people who want to reduce risk of cardiovascular disease should consider dietary changes that are anti-inflammatory (that is, a diet high in antioxidants, anti-inflammatory herbs, and antioxidant-rich foods–that’s colorful fruits and vegetables, curry, turmeric, rosemary, ginger, green tea, dark chocolate, low-toxin fish like salmon or sardines).

Statin drugs, though they come with some side effects, have proven of benefit to certain groups of people with cardiovascular complications, including diabetics, those who have had a heart attack, and those diagnosed with cardiovascular disease. Like many others, Dr. Cass recommends supplementing with CoQ 10 if you’re taking statins. She also supports use of omega-3 fatty acids (from fish oil), niacin (though not recommended for diabetics), plant sterols, tocotrienols (a form of the antioxidant vitamin E), and D-ribose for controlling cholesterol and otherwise countering cardiovascular disease. In addition, the B vitamins are recommended to help lower homocysteine, high levels of which are associated with artery damage and increased risk of heart disease.

Citation: Hyla Cass, M.D., Supplement Your Prescription: What Your Doctor Doesn’t Know About Nutrition (Basic Health Publications, 2007).