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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