Statins for those w/o high cholesterol

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The Food and Drug Administration approved the new criteria last month for Crestor, which is made by AstraZeneca and is the nation’s second best-selling statin, behind Lipitor by Pfizer. AstraZeneca plans soon to begin a new marketing and advertising campaign for Crestor, based on the new F.D.A.-approved criteria.

Under those criteria, an estimated 6.5 million people in this country who have no cholesterol problems and no sign of heart problems will be deemed candidates for statins. That is in addition to the 80 million who already meet the current cholesterol-based guidelines — about half of whom now take statins.

The new Crestor label says it may be prescribed for apparently healthy people if they are older — men 50 and over and women 60 and over — and have one risk factor like smoking or high blood pressure, in addition to elevated inflammation in the body.

The clinical trial on which the F.D.A. approved the new Crestor use was a global study of nearly 18,000 people. It looked only at patients who had low cholesterol and an elevated level of inflammation in the body as measured by a test called high-sensitivity C-reactive protein.

There is a debate over the blood test being used to identify the new statin candidates. Instead of looking for bad cholesterol, the test measures the degree of inflammation in the body, but there is no consensus in the medical community that inflammation is a direct cause of cardiovascular problems.

Some patients have long complained of muscle aches from taking statins. And doctors periodically check patients on the drugs to make sure liver enzymes are not abnormally high. Doctors, though, have generally seen those risks as being more than offset by the drugs’ benefits for people with high levels of “bad” cholesterol and a significant risk of cardiovascular disease.