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Should I take a statin even if I don't have high cholesterol?

Consumer Reports News: June 29, 2010 04:08 AM

Earlier this year the Food and Drug Administration approved rosuvastatin (Crestor), a drug usually used to lower LDL (bad) cholesterol, for use even in some people who have normal LDL levels. Why? Because it turns out that the drug (and probably other statins), also appear to lower levels of C-reactive protein, which can help indicate inflamed coronary arteries. And inflammation can contribute to heart disease by damaging the arteries and encouraging the growth of clot-forming plaque deposits.

So is it time to get your CRP measured and possibly take a statin if that level is high, even if your LDL isn’t? Probably not. Here’s why.

Modest benefits, real risks

The FDA approved Crestor for men 50 and older and women 60 and older who have a high CRP level (greater than or equal to 2 milligrams per liter) plus at least one other traditional cardiovascular risk factor. That could include having a high LDL level. But it could also be any other coronary risk factor, such as low HDL (good) cholesterol, high blood pressure, smoking, or a family history of premature heart disease.

The FDA made that approval based on a trial published in the New England Journal of Medicine in November 2008. It looked at approximately 18,000 people with LDL levels below 130 mg/dl but a high CRP. Half got Crestor every day and half got a placebo. After about two years there were 44 percent fewer cardiovascular events (such as non-fatal heart attack and stroke) in the treatment group.

Sound impressive? Well, maybe not, since cardiovascular disease is relatively uncommon in the group of people enrolled in the study. So the absolute reduction in the rate of heart attack, stroke, and cardiovascular death went from about 2 per 100 patients in the placebo group to 1 per 100 in the treatment group. At that rate, 120 people would have to be treated for nearly two years to prevent one event. A benefit, yes, but is it one that’s worth the treatment’s costs?

At the same time, taking statins does have risks. Research suggests that between 5 and 10 percent of people who take a statin drug of any kind experience muscle aches, soreness, tenderness, or weakness.

Even more worrisome, in this study, Crestor drug appeared to increase the risk of type 2 diabetes. Physician-reported diabetes was more frequent in the Crestor group (270 reports or 3 percent) versus the placebo group (216 reports, or 2.4 percent). In other words, one additional case of type 2 diabetes would be seen in about every 165 people taking Crestor.

And there is one more thing you should know: The JUPITER study was supported by AstraZeneca, the makers of Crestor, and its lead author, Paul M. Ridker, MD, is a co-inventor of patents related to the use of inflammatory markers in cardiovascular disease, including the use of CRP in the evaluation of patients’ risk of the disease. The patents are held by Brigham and Women’s Hospital.

Bottom line: Our consultants say that in people with a normal LDL and an elevated CRP, the benefits of taking Crestor don’t clearly outweigh the risks. Most people with a normal LDL and just one other risk factor probably don’t need to get their CRP level measured. The same is also true of people at substantial risk of heart attack. That’s because those individuals usually need to take a statin regardless of their CRP level.

However, there may be one group of people who could benefit from learning about their CRP. That’s people at moderate coronary risk, with a borderline high LDL, for example, and one or more additional risk factors. In those individuals, a high CRP might tip the scales toward taking a statin. And in that case, our Best Buy Drug recommendations are generic lovastatin, generic pravastatin, generic simvastatin, or atorvastatin (Lipitor).

Want to read more about who should reconsider taking a statin to lower their cholesterol? See our Consumer Reports Best Buy Drugs Special Report on Statins.

The editors of ConsumerReportsHealth.org

These materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multi-state settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

If you think you have experienced an adverse event with this drug or any drug, especially if it is of a serious nature, it is important to 1) tell your doctor immediately and 2) report the event to the Food and Drug Administration via the FDA's MedWatch website or by calling 1-800-FDA-1088.

Aaron Bailey


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