Statin side effects: reason to consider the alternatives?

There’s been a lot of buzz about a new study published in the New England Journal of Medicine that found that statin use by people with low cholesterol but high levels of an inflammation marker (C-reactive protein, or CRP) very substantially decreased heart attack and stroke rates over a two-year period. The study participants were men 50 and older and women 60 and older with no history of cardiovascular disease or high cholesterol, but with high levels of CRP. Many also had other cardiovascular risk factors such as obesity, high blood pressure, or smoking.

Does this study suggest that millions of people with normal cholesterol levels but high levels of CRP should start taking statins on a regular basis? There is a caution here, which was raised by an editorial in the NEJM accompanying the study, and has been echoed in many other places, from the New York Times to the British Journal of Medicine: what about the long-term effects of taking statins? It was worrisome to note that in this study, participants taking the statin (Crestor) over the two-year period had an increase in diabetes. This finding brings to mind an unfortunate pattern marring the US drug approval process in recent decades: drugs win approval and are widely marketed, but several years later it turns out that there are side effects to long-term use, sometimes so prevalent and so severe that recommendations for use of the drug must be curtailed. So it’s best to give very careful thought to “who should take a statin?” (This was the title of the New York Times editorial regarding the study.)

Furthermore, when discussing how to manage chronic conditions over the long term, we shouldn’t neglect good options in nutrition and dietary supplements. Here’s how George Carter at our sister organization FIAR puts it, in his direct response to the NEJM study:

Are there cheaper and safer alternatives to lowering CRP? Yes! A low-fat diet, for example, can cut CRP in half in 4 weeks.

How about just adding some fiber? See http://www.medscape.com/viewarticle/553590.
They found an 18.1% reduction in CRP using supplemental fiber. While rosuvastatin appears to have done better with a 37% reduction, just using fiber can get one half way there. Also, it is unclear what degree of reduction might be clinically important, although a generally agreed upon level of greater than 1.0 mg/liter CRP is considered problematic.

Vitamin C has also shown some benefit. One study reported that participants who took about 500 milligrams of vitamin C supplements per day saw a 24 percent drop in plasma C-reactive protein (CRP) levels after two months. Another study among healthy non-smokers saw a 25.3% reduction in CRP levels among those with a level greater than 1.0 mg/L at the beginning of the study.

We’ll conclude by adding that of course dietary supplements like fish oil (with their omega-3 fatty acids), niacin, pantethine, CoQ10 and the B vitamins also have a role to play in controlling cardiovascular risk. Their effectiveness has been widely studied and documented, they have been in use for a long time, and they have very well-known safety profiles. It only makes sense that these supplements should be part of the arsenal of protective and preventive means available to those concerned about managing risk to the heart and circulatory system.

References:

Ridker, PM, et al. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. NEJM, 9 Nov 2008

Who Should Take A Statin? Editorial in the New York Times, Nov. 17, 2008. Accessed at http://www.nytimes.com/2008/11/17/opinion/17mon2.html?hp

FIAR press release on NEJM statin study accessed at
http://www.fiar.us/StatinResultsMediaLetter.pdf

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The Lowdown on Lipodystrophy – Nelson Vergel on “HIV Lipodystrophy: Where Are We After 10 Years?”

We’d like to recommend this article, by long-time AIDS treatment activist Nelson Vergel, which appears in the July-Dec. 2007 issue of GMHC’s Treatment News

It’s available online at

http://www.gmhc.org/health/treatment/ti/ti21_3_4.html#3

Lipodystrophy has been one of the most discussed side effects of HIV medications in the past ten years, and, as this article points out, its potentially devastating psychological effects have added urgency to the search for scientific understanding about the condition, and treatment options to address it.

This excellent summary divides the discussion into three parts:

–lipoatrophy (fat loss in the face, buttocks, arms and legs)

–lipohypertrophy (fat accumulation in specific areas of the body such as the neck, belly, upper torso, and breasts)

–lipid abnormalities (high LDL [“bad”] cholesterol and triglycerides, low HDL [“good”] cholesterol)

Nelson outlines how Zerit and AZT were especially implicated in lipoatrophy; he also sorts through the ongoing uncertainties about the origins of lipohypertrophy and lipid abnormalities in people with HIV on HAART.

This article is also very useful in reviewing the treatment options for these three conditions, including facial wasting reconstruction therapies like Sculptra (formerly Newfill) for lipoatrophy; prescription drugs for lipohypertrophy (testosterone or Metformin*); nutritional supplements like fish oil and Niacin for lipid abnormalities (these are often most successful when used along with diet and exercise programs, and can enhance the effectiveness of prescription statins).

Nelson Vergel continues to do a great service in making this kind of treatment information available to PWHIV. For more info, you can also visit the website http://www.facialwasting.org, or subscribe to the pozhealth internet HIV health discussion group by sending a blank email to pozhealth-subscribe@yahoogroups.com.

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*See additional posts on this Blog for a recommendation about supplementing with B vitamins when taking Metformin.

FAQ on nutritional supplements

This post runs a little long, but we think it’s worthwhile to put up the FAQ about nutritional supplements recently posted by the New York Buyers’ Club. It answers a lot of (sometimes anxious) queries about supplements, and also gives a quick rundown on some of the top uses of supplements among the NYBC membership.

What are supplements?
A nutritional or dietary supplement (or just plain supplement), as defined by the Dietary Supplement Health and Education Act (DSHEA) of 1994, is “a product (other than tobacco) that is intended to supplement the diet and that contains one or more of the following: vitamins, minerals, herbs or other botanicals, amino acids, or any combination of the above ingredients,” and can be taken in tablet, capsule, powder, or liquid form.
NYBC specializes in supplements for those with HIV, hepatitis C, and other chronic conditions. Our Supplement Fact Sheets contain information on more than 100 supplements commonly used by our Members. Our nonprofit purchasing co-op stocks these supplements on a regular basis, and can also special-order many other supplements on request.
Why take supplements?
There is a great deal of research showing that supplements can help people manage serious chronic conditions such as HIV and hepatitis. Supplements can also be useful in addressing many common health issues, such as high cholesterol, diabetes, depression, arthritis pain, gastrointestinal disorders, etc. (see our short list of specifics below). Some supplements are derived from ancient traditions of use (for example, the botanicals of India’s Ayurvedic tradition), while other items (such as vitamins or amino acids) have been isolated and used as supplements much more recently. The scientific study of supplements has blossomed in recent decades, so we now have better evidence about many of them—even traditional botanicals—than we ever did in the past.
Are supplements considered “medicine”?
While supplements may have medicinal properties, they are not regulated in the same way that prescription drugs are, and are therefore accompanied by the disclaimer: “These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
The fact that supplements are not regulated in the same way that prescription drugs are naturally gives rise to concerns about purity, efficacy, and safety – so it’s good to have a knowledgeable ally like NYBC on your side! Collectively, we have many years of experience in using supplements, in researching information on them, and in evaluating suppliers to obtain the best quality product.
Are supplements “safe”?
Under current US regulations, supplements are assumed to be safe on the basis of their history of use, or because they are found in the food supply (like the microorganisms in yogurt or the vitamins and minerals in foods). The US Food and Drug Administration is responsible for removing supplements from the market if it finds evidence that they are unsafe, but it’s worth noting that this happens quite rarely. (The removal from the market of ephedra [aka the Chinese herb Ma huang], used at high dosage as a diet pill, is practically the only significant example since 1994). However, while supplements may be “assumed to be safe,” everyone who takes them needs to pay attention to the recommended dosage and any cautions or warnings. If you exceed the recommended dosage of certain supplements, there may be side effects, sometimes serious. Furthermore, a supplement may have negative interactions with other medications you are taking, or a particular supplement may not be a wise choice for you due to other health concerns. That’s why it’s always important to discuss your supplement use with your doctor.

Here are just a few examples of potentially dangerous supplement-medication interactions (from the National Center for Complementary and Alternative Medicine’s website) – further proof that consulting your physician about supplement use is crucial:

• St. John’s Wort can increase the effects of prescription drugs used to treat depression. It also dangerously interferes with drugs used for HIV, cancer, birth control, and rejection of organ transplants

• Ginseng can increase the stimulant effects of caffeine (as in coffee, tea, and cola). It can also lower blood sugar levels, creating the possibility of problems when used with diabetes drugs

• Ginkgo, taken with anticoagulant or antiplatelet drugs, may increase the risk of bleeding. Ginkgo may also interact with certain psychiatric drugs and with certain drugs that affect blood sugar levels

Of course, doing your own “homework” is also encouraged. Be sure to bring any notes or printouts from your research to share with your healthcare provider. That way, you’ll both be literally on the same page.
Identity, Purity and Potency
Safety is also a matter of product quality. Is the product what it claims to be on the label (that is, is it really fish oil)? This is the product Identity. Does the product contain any unwanted contaminants like heavy metals, insect parts, rodent droppings? All foods and medicinal products face these issues of Purity. And finally, does it have as much of the claimed amount of a substance? For example, if it says 100 mg of niacin, does it have that amount? This is the product’s Potency. These issues are of ongoing concern. NYBC has done everything possible to assure that products meet these standards. Websites such as http://www.consumerlab.com can help. Also indications of quality such as USP or other labels further add assurance. The good news is that the vast majority of products tested by consumerlab, for example, pass their tests. Still, NYBC believes an appropriately funded agency of the FDA could do more rigorous, routine and comprehensive testing.
What is CAM?
CAM is an acronym for complementary and alternative medicine. The use of supplements is considered CAM. Some prefer the term integrative medicine.
The National Center for Complementary and Alternative Medicine (NCCAM), a division of the US National Institutes of Health, defines CAM as “a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine.” NCCAM, like the US Office of Dietary Supplements, came into being after passage of DSHEA, and marks the federal government’s decision to commit funding to research and education about CAM. Over a billion dollars in your tax dollars have been spent by these agencies since their start.

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Using Supplements
What supplements can I use to improve my immune system?
Agents such as a potent multivitamin, NAC (N-acetyl cysteine), alpha lipoic acid and whey can all help offset oxidative stress and nutrient losses caused by HIV as well as the free radical generation and inflammation-related damage that some antiretroviral drugs cause.
For those with HIV, supplementation can be a valuable assist in restoring the body’s immune system, as evidenced by many studies, such as Dr. Jon Kaiser’s HIV Micronutrient Study, which showed a significant increase (26%) in the CD4 counts of the subjects who maintained a supplement regimen in addition to their regular medications. FYI: NYBC offers a “MAC Pack” (Micronutrient – Antioxidant Combination Pack), a product very similar to the one used in the study.
What supplements can be used to improve gut function?
Acidophilus or bifidus, glutamine, whey proteins, Saccharomyces boulardii (Florastor) and a good multi can all be important to offset gastrointestinal problems, whether HIV-related or of other origin.
What supplements can I use to manage my blood fats (cholesterol and triglyceride levels)?
“Bad cholesterol” (LDL) and triglycerides can be reduced with agents such as carnitine, pantethine, and fish oils. Niacin may be an excellent option which can also help increase HDL (“good cholesterol”). For heart health in general, aside from diet and exercise, CoEnzyme Q10 may also be of help (may also be useful in countering statin-related side effects).
What supplements are used to improve mental function and/or mood?
Acetylcarnitine, 5-HTP, tyrosine, ginkgo biloba, fish oils, SAM-e, DHEA, theanine, or St. John’s Wort may help mental function and alleviate depression, though each of these must be taken with some care (and not all together!)
See also: a full dossier on Memory Loss and Other Brain Problems from our Health+HIV section of Recommended Reading on the website http://www.newyorkbuyersclub.org; also recommended is the NYBC info sheet on Depression and supplements on this blog, under “Depression.”
What supplements can I use to combat fatigue?
Various conditions can cause fatigue, but in general, B12 (methylcobalamin) and Eleuthero (used to be “Siberian ginseng” – don’t use with high blood pressure!) may all help to improve energy. A good start may also be as simple as a good multivitamin!
For more information about the causes and treatments for fatigue, see our Fatigue Fact Sheet on the NYBC website.
What supplements can I use to stabilize my weight?
For those experiencing weight loss, whey proteins, carnitine and creatine plus CLA may all help – but of course especially in conjunction with a good diet and routine exercise! And we agree with Dr. Jon Kaiser and many others: resistance exercise remains an important component of a successful HIV management plan.
What supplements are used to treat nausea?
NYBC recommends ginger; marijuana, while effective, is not carried by the NYBC, as it is not yet approved for medical use in New York. For detailed information about the causes and treatments for nausea, see Health+HIV section of Recommended Reading on the NYBC website.
What supplements are used to improve liver function?

Liver function can be impaired due to several reasons, including disease, alcohol abuse, and the effects of some cholesterol-lowering drugs (statins).
While making sure there aren’t any interactions with your meds, supplements like milk thistle (Silymarin), NAC, alpha lipoic acid, Hepato-C or Hepato-Detox, Hepatoplex I or II, Ecliptex, SAM-e and Clear Heat are options to consider (again, not all at once!)
What supplements can be used to treat diarrhea?
NYBC suggests supplementing your diet with glutamine and calcium. For more information about the causes and other possible treatments, see our Fact Sheet about diarrhea in Recommended Reading, at http://www.newyorkbuyersclub.org.
What supplements can combat neuropathy?
Much scientific evidence now points to acetylcarnitine as an effective approach to countering neuropathy (numbness, tingling, or pain, usually in the extremities, which can be caused by HIV, diabetes or by some medications).