AstraZeneca gets OK for expanded Crestor use

WASHINGTON, D.C.; February 09, 2010

The drug would aimed at preventing heart attacks and strokes for people who have an inflammation indicator known as C-Reactive Protein.

Federal regulators have granted AstraZeneca approval to market its cholesterol pill Crestor as a preventive measure against heart attack and stroke in patients with healthy cholesterol levels.

The Food and Drug Administration decision will allow the company to promote Crestor to millions of U.S. patients who traditionally have not been candidates for cholesterol-lowering drugs.

A much-heralded study in 2008 showed Crestor reduced heart attack, stroke and other problems by 44 percent in patients with normal cholesterol and slight heart disease risks.

All the patients had elevated levels of the so-called C-reactive protein, a key indicator of inflammation that can lead to clogged arteries, causing heart attack or stroke.

Scientists are still unsure whether the positive results were due to lower cholesterol or C-reactive protein, since Crestor reduces both.

Under the new language, Crestor is approved for men 50 and older, and women 60 and older who have elevated C-reactive protein.

Patients must also have at least one risk factor for heart trouble, such as high blood pressure or a smoking habit.

There are some estimates that this will open the door to potentially 6 million more patients being candidates for this cholesterol lowering drug.

One cardiologist believes it could prevent 28,000 heart attacks, strokes, and deaths due to cardiac arrests.

However, Crestor's retail cost is $141 a month. On that basis, it would cost $287,000 a year to prevent each of those events.

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