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Questions Raised Over Expanded Use of Crestor

Mar 31, 2010 | Parker Waichman LLP

Astrazeneca, the maker of Crestor, is about to launch a marketing blitz touting the statin as a preventive medicine.  But some critics think the benefits of using the drug this way don't outweigh its risks. 

The new criteria for Crestor was approved by the Food  & Drug Administration (FDA)  last month, after the agency reviewed a clinical study which showed a small reduction of strokes, heart attacks and other “cardiovascular events” among people taking the statin, compared with patients taking a placebo. The international study involved nearly 18,000 people who had low cholesterol readings and an elevated level of inflammation in the body as measured by a test called high-sensitivity C-reactive protein , or CRP.

According to The New York Times, that study was led by Paul M. Ridker, a Harvard medical professor and cardiologist at Brigham and Women’s Hospital. When Ridker convinced AstraZeneca to pay for his study, it had already been rejected by the National Institutes of Health and at least two other companies.

Ridker is also the inventor of the CRP test. According to the Times, he receives undisclosed amounts of royalties from the CRP test.

Ridker told the Times his study found a 55 percent reduction in heart attacks, a 48 percent reduction in stroke, and a 45 percent reduction in angioplasty bypass surgery in healthy people treated with Crestor. But critics of the study point out that these claims may be misleading because the patients were so healthy that they had little risk to begin with.

As the Times points out, the 55 percent relative difference in heart attacks between the two groups translates to only 0.2 percentage points in absolute terms — or 2 people out of 1,000. In real numbers, 500 people would need to be treated with Crestor for a year to avoid one usually survivable heart attack. One cardiologist told the Times that while the difference seen id Ridker’s study was statistically significant, it wasn’t clinically significant.

Some critics question whether that small difference outweighs Crestor's possible side effects.  For example. one recent study in The Lancet found that treating healthy people with statins like Crestor could raise a person’s risk of developing Type 2 diabetes by nine percent. According to The Times, that study was based on an analysis of most of the major clinical studies of statins. It including unpublished data and the results of the clinical study that the FDA reviewed before approving expanded use of Crestor. Because of the findings, the FDA did require AstraZeneca to add the diabetes risk to the Crestor label.

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