BEIJING, Feb. 9 -- The Food and Drug Administration of the United States has approved wider use of Crestor, the AstraZeneca PLC's cholesterol-lowering drug, allowing the company to market the drug to patients who don't have signs of heart disease.
FDA's approval broadens the indication for Crestor as a preventative measure for cardiovascular disease.
The approval was based on a AstraZeneca-sponsored study of almost 18,000 patients known as "Jupiter," which looked at patients whose cholesterol levels were normal or slightly elevated but who had an elevated C-reactive protein (CRP) level.
CRP is a key indicator of inflammation that can lead to clogged arteries, causing heart attack or stroke.
The Jupiter study, which compared patients on Crestor with patients receiving a placebo, looked at events such as death, stroke, heart attacks, hospitalization for heart problems and surgery to treat clogged arteries; patients on Crestor showed a 44 percent reduction in the number of events after an average of 1.9 years.
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.
(Agencies)
