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

Care for your Heart

CATIE has an excellent review of heart health, abstract below. It reviews the risk factors, methods for assessing heart health and means to help reduce risk of heart attack and stroke. There is a special emphasis on issues affecting people living with HIV.

Fact Sheets

HIV and cardiovascular disease: keeping your heart and blood vessels healthy
Summary

Cardiovascular disease affects the health of your heart and blood vessels and can lead to heart attacks or stroke. You may think that these are problems that affect only older people. However, emerging research suggests that HIV infection increases the risk for cardiovascular disease, including heart attacks and stroke, even in relatively young people. So, regular monitoring by your doctor of your overall and cardiovascular health should be part of your plan for living longer and living well. Getting on treatment for HIV is one of the best things you can do to stay healthy. This Fact Sheet has many additional steps you can take to reduce your risk for heart attacks, stroke and other complications.

This CATIE fact sheet addresses the potential of certain supplements to support cardiovascular health: Omega-3 fatty acids (fish oil); niacin; carnitine; CoQ10; and chromium (subject of an interesting small study in Canada).

Read more about supplements for cardiovascular health at NYBC’s pages on “Cholesterol/Triglycerides” at
http://nybcsecure.org/index.php?cPath=35 and on “CoQ10” at http://nybcsecure.org/index.php?cPath=47 (includes practical suggestions for optimizing your use of CoQ10).

Nelson Vergel: “Survivor Wisdom”

A Talk by Nelson Vergel: “Survivor Wisdom: Advances in Managing Side Effects, Living Well, and Aging with HIV” – New York City, November 9, 2010

How could you not be impressed by the schedule HIV treatment activist Nelson Vergel keeps? A few days before he arrived in New York to share his “Survivor Wisdom” with New York Buyers’ Club members and guests, he was an invited participant at the 12th International Workshop on Adverse Drug Reactions and Co-morbidities in HIV in London. The founder and moderator of the “pozhealth” group on Yahoo—the largest online discussion group for HIV issues–Nelson also finds time to answer questions on a forum hosted by thebody.com. In addition, he serves as a community member of the federal government’s Department of Health and Human Services HIV treatment guidelines advisory board. And did we mention that he’s the author of a new book, “Testosterone: A Man’s Guide,” especially useful for people with HIV who are considering testosterone therapy to address fatigue and other problems?

As you might expect, Nelson also covered a lot of territory in his NYBC talk, which was co-hosted by the City University of New York’s Graduate Center. He briefly updated the audience on new treatments and guidelines, then reviewed the exceptional case of the HIV+ “Berlin patient,” whose apparent cure following a bone marrow transplant has opened up, at least tentatively, some new lines of research about curing HIV.

Most of Nelson’s talk, however, dealt with familiar issues in managing HIV symptoms and medication side effects: cardiovascular health challenges, lipoatrophy (facial wasting especially) and body fat accumulation (lipohypertrophy), aging with strong bones, fighting off fatigue, minimizing the risk of anal cancer.

Amid this discussion of symptoms and side effects, Nelson spent time on the topic of supplements. His first point, which NYBC would certainly agree with, is that a lot of good evidence has accumulated about the benefit of multivitamin supplementation, and a multivitamin plus antioxidant combination, for people with HIV. These “micronutrients,” as they’re called in the scientific literature, can enhance survival, delay progression of disease in people not yet on HIV meds, and increase CD4 counts in people taking the meds. We have to admit we were pleased when Nelson also took a moment to praise NYBC (and especially our Treatment Director George Carter) for making available an inexpensive, “close equivalent” of the multivitamin/ antioxidant combination that was the subject of Dr. Jon Kaiser’s well-known research and that led to the development and marketing of K-PAX. New York State residents, as Nelson pointed out, have access to many such supplements through formularies. But for residents of other states, this half-price version of the multivitamin/antioxidant combination (MAC-Pack or Opti-MAC-Pack) can provide welcome relief in the budgetary department.

Our speaker then ran through a list of about a dozen supplements that have reasonably good evidence to support their use by people with HIV. He chose to focus more closely, however, on just a few:

Niacin. Despite “flushing” that makes it difficult for some to use, niacin can be very effective in bringing up levels of HDL (“good”) cholesterol in people with HIV. Since cholesterol control is a major long-term health issue for many people on HIV meds, and since recent research suggests that raising HDL cholesterol levels may be an extremely important factor in reducing cardiovascular risk, niacin may be a top choice for many. (Fish oils/omega-3 fatty acids, plant sterols, pantethine, carnitine, and CoQ10 are other supplements that NYBC and many others put in the category of “supports cardiovascular health.”)

Vitamin D. Seems that, even at the London conference Nelson had just attended, the “sunshine vitamin” was a hot topic. Partly that’s because people with HIV have recently been found to have a high prevalence of Vitamin D deficiency, and then because Vitamin D, calcium and other mineral supplementation is a logical approach to addressing long-term challenges to bone health in people taking HIV meds. (Look on the NYBC blog for a whole host of other recent studies about Vitamin D’s potential benefits, from reducing cardiovascular risk to cancer prevention—even as a way of warding off colds and flu.)

Carnitine. This is a supplement, Nelson told the audience, that he’s taken for many years. Reported/perceived benefits: to improve fatigue, lipids, brain function and neuropathy. (NYBC Treatment Director George Carter put in that “acetyl-carnitine”—a form of the supplement that crosses the blood/brain barrier–has shown the most promise for dealing with neuropathy.)

Probiotics. The vulnerability of the gut in HIV infection, and the well-documented problems people with HIV experience in absorbing nutrients, make probiotics a very helpful class of supplements for long-term health maintenance. (Probiotics, good or “friendly” bacteria residing in the gut, are available in a variety of products, from yogurt to supplements. There’s quite a bit of research about the effectiveness of different varieties, and note as well that there are some newer formats that don’t require refrigeration.)

Above and beyond the treatment issues involving supplements, meds, and other strategies, Nelson referred several times to areas where there’s a need for advocacy. He mentioned the cure project, for one, but also a national watch list to help people follow and respond to the devastation created by recent funding cuts and the resultant waiting lists in the ADAP programs of many states, such as Florida.

All in all, NYBC members and guests would doubtless agree: a very thought-provoking presentation, with much helpful information to take away. For more on these and other issues, be sure to check out the NYBC website at:

http://www.newyorkbuyersclub.org/

[A version of this article also appears in NYBC’s free e-newsletter, THE SUPPLEMENT, along with additional reporting on a new Mayo Clinic guide to supplements, and a look at the current state of regulation and research on supplements in the US.]

NEW! Managing and Preventing HIV Med Side-Effects

To mark its fifth anniversary, the New York Buyers’ Club has prepared a special edition of SUPPLEMENT. In it you will find a concise Guide to managing and preventing HIV medication side effects with supplements and other complementary and alternative therapies.

This is an invaluable introduction to how nutritional supplements can be used to counter those side effects that can make life miserable–or even disrupt treatment adherence–in people taking antiretroviral medications for HIV.

Read about approaches to dealing with diarrhea, nausea, heart health issues, diabetes, insomnia, fatigue, liver stress, lipodystrophy, anxiety and depression.

This FREE Guide is available online at:

http://newyorkbuyersclub.org/

On the NYBC website you can also SUBSCRIBE to the nonprofit co-op’s quarterly FREE newsletter, THE SUPPLEMENT, which continues to offer a unique perspective on current evidence-based use of supplements for chronic conditions including cardiovascular disease, diabetes/insulin resistance, hepatitis and other liver conditions, anxiety/depression, osteoarthritis, cognitive and neurorological issues, and gastrointestinal dysfunction.

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

Fish oil lowers triglycerides in people with HIV, according to a 2007 study

Several antiretroviral drugs for people with HIV can cause elevated blood fats, which may increase the risk for cardiovascular disease. One of the therapies that has been tested for managing high cholesterol and triglycerides is fish oil, which has a long history of use to counter cardiovascular disease.

From the March 1, 2007 Journal of Acquired Immune Deficiency Syndromes: French researchers conducted a prospective, double-blind trial to assess the effect of N-3 polyunsaturated fatty acids — better known as omega-3 fatty acids — found in fish oil.The study included 122 HIV positive patients on HAART who still had elevated triglyceride levels (between 2 and 10 g/L) after a 4-week diet. Participants were randomly assigned to receive 2 capsules containing 1 g of fish oil (Maxepa) or else placebo capsules 3 times daily for 8 weeks, followed by an open-label phase during which all participants received fish oil. Ten individuals with baseline triglyceride levels above 10 g/L were not randomized and received open-label fish oil from the outset.

Results

The median triglyceride level decreased by 25.5% in the fish oil group, while rising by 1% in the placebo group.
At week 8, the mean triglyceride levels were 3.4 and 4.8 g/L, respectively.

Triglyceride levels normalized in 22.4% of subjects in the fish oil arm compared with 6.5% in the placebo arm (P = 0.013).

58.6% and 33.9%, respectively, experienced at least a 20% reduction in triglycerides (P = 0.007).

Patients in the fish oil group experienced a slight decline in total cholesterol level, compared with a small increase in the placebo arm. During the open-label phase, the decrease in triglycerides was sustained at week 16 for patients in the fish oil group, while those initially in the placebo group experienced a 21.2% decrease after switching to fish oil.

The patients with baseline triglyceride levels above 10 g/L experienced a 43.6% decrease by week 8.

No significant differences in adverse events were observed between the fish oil and placebo arms.


Conclusion “This study demonstrated the efficacy of [polyunsaturated fatty acids] to lower elevated triglyceride levels in treated HIV-infected hypertriglyceridemic patients. [N-3 polyunsaturated fatty acids] have a good safety profile.”“The place of polyunsaturated fatty acids in the armamentarium of treatment of metabolic disorders in HIV-infected patients needs to be further investigated with future prospective studies…” 

CITATION: P De Truchis, M Kirstetter, A Perier, and others. Reduction in triglyceride level with N-3 polyunsaturated fatty acids in HIV-infected patients taking potent antiretroviral therapy: a randomized prospective study. JAIDS 44(3): 278-285. March 1, 2007.