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Buzzword: C-reactive protein

Consumer Reports News: December 22, 2009 11:08 AM

Crestor
What does it mean? 
C-reactive protein, or CRP, is a protein produced by the liver. High levels of CRP can indicate chronic infection or inflammation such as colitis, rheumatoid arthritis, hepatitis, or gingivitis. Elevated CRP levels can also be a rough indicator of your risk of heart disease, but there’s still a lot of uncertainty about this  
and there’s no consensus on whether an elevated CRP, alone is reason enough to start people on medications. Conventionally, physicians have instead focused on elevated levels of LDL cholesterol, or "bad" cholesterol, to determine if a person should be started on a medication, such as a statin, that has been shown to lower LDL-cholesterol levels and prevent heart attacks.

Why the buzz? In what has become a controversial move, a Food and Drug Administration advisory committee recently voted 12-4 with one abstention that the cholesterol-lowering statin drug, rosuvastatin (Crestor), be approved for use in people with normal LDL-cholesterol levels and no history of heart disease, but with elevated CRP levels. A study released last year found that Crestor reduced, heart attacks, stroke and death, in people fitting those criteria. If the advisory committee’s recommendation is approved by the FDA, this would mean millions of healthy Americans would meet the criteria and be likely candidates for Crestor use.

However, opponents to approval of this new indication point out that Crestor can also cause serious side effects, including diabetes and a sometimes life-threatening muscle problem called rhabdomyolysis. And its unclear whether elevated CRP levels are an accurate gauge of future heart troubles. For example, a report released in October by the U.S. Preventive Services Task Force concluded that there is not enough evidence to determine if CRP levels reliably predict whether people will go on to suffer heart attacks, strokes, or death.

Bottom line: Stay tuned. The FDA hasn’t made its final decision on Crestor and isn’t expected to do so until sometime during the first few months of next year. We are closely following this situation and will keep you apprised of any major updates or changes in our recommendations. For more on Crestor and other statins, check out our free Best Buy Drugs report on those medications.

Steve Mitchell, associate editor, Consumer Reports Best Buy Drugs

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