Crestor Approval Expanded For People Without High Cholesterol
TUESDAY, Feb. 9 -- U.S. Food and Drug Administration approval for Crestor (rosuvastatin) has been widened to include people who have no obvious symptoms of heart disease, Dow Jones reported.
Maker AstraZeneca can now market the drug to people with normal or slightly above-normal levels of cholesterol, a group formerly considered at low risk for cardiovascular disease, the news service said.
Crestor was deemed effective in the company-sponsored "Jupiter" trial involving nearly 18,000 people with normal or near-normal cholesterol but elevated levels of C-reactive protein (CRP), a marker of bodily inflammation.
Elevated CRP may predict development of cardiovascular disease, the news service said.
Crestor and other statin drugs were designed to lower LDL, often referred to as "bad" cholesterol, which can lead to the buildup of fatty deposits in the arteries and pose an increased risk of heart attack and stroke.
Among participants in the Jupiter trial, people with normal or near-normal cholesterol who took Crestor for an average of 1.9 years showed a 44 percent reduction in heart attack, stroke and other cardiovascular problems, compared with those who took a placebo, the Dow Jones report said. The results were so overwhelming that the trial was halted early.
In December, an FDA-sanctioned panel of experts voted 12 to 4 to recommend approval of Crestor for people without cardiovascular disease.
The U.S. National Library of Medicine has more about this drug.
Posted: February 2010