Crestor Approved for Wider Use

Please read the details, the statistics are not very impressive and the cautions significant.

February 9, 2010

Crestor Wins Approval as a Drug to Prevent Heart Disease

AstraZeneca won approval Monday to promote its cholesterol fighting drug Crestor for preventing heart disease in a vast new market of people with healthy cholesterol but other heart risks.

Crestor won approval from the Food and Drug Administration for reducing the risk of heart attacks, strokes, bypass operations and artery-clearing procedures in people with high levels of C-reactive protein in addition to at least one other risk factor. That clears the way for the drug for millions of people who are not typically prescribed cholesterol drugs now.

C-reactive protein, or C.R.P., is a sign of inflammation associated with heart disease. Patients should be men at least 50 years old or women at least 60, the F.D.A. said.

The approval was based on data from a nearly 18,000-patient study, called Jupiter, financed by AstraZeneca.

The study tested Crestor versus a placebo in middle-age people with healthy cholesterol, but high levels of C.R.P. The rate of major cardiovascular problems was 1.6 percent for patients treated with Crestor compared with 2.8 percent with a placebo, the F.D.A. said.

An F.D.A. advisory panel that reviewed the Jupiter results in December backed wider use but voiced concern that doctors might use Crestor too broadly in patients with low risk. F.D.A. reviewers had told the panel up to 6.5 million Americans meet the criteria used in the Jupiter study.

On Monday, the F.D.A. said doctors “must interpret the results of the Jupiter trial with caution.”

For example, there was no evidence Crestor helped patients with high C.R.P. but no traditional risk factors like high blood pressure, lowHDL or “good” cholesterol, smoking or a family history of early heart disease, the F.D.A. said.

Wider approval for Crestor is likely to increase sales of the drug, but industry analysts say the size of the opportunity is uncertain because of the impending arrival of cheaper generic versions of the rival Lipitor from Pfizer in late 2011.

Copyright 2010 The New York Times Company


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