New Indication Approved for Rosuvastatin
Crestor (rosuvastatin calcium) has received FDA approval to market the drug as a treatment for reducing the risk of stroke, myocardial infarction (MI), and arterial revascularization procedures in patient without clinical evidence of coronary heart disease but who have an elevated risk of cardiovascular disease (CVD).
Approval of the new indication for the lipid-lowering agent, which is made by AstraZeneca, of Wilmington, DE, was based on data from the JUPITER (Justification for the Use of statins in Primary Prevention: an Intervention trial Evaluating Rosuvastatin) study.
The trial evaluated the effect of rosuvastatin 20 mg on decreasing the risk of major CVD events in a previously unstudied population. The drug was shown to reduced the risk of MI by 54%, stroke by 48%, and arterial revascularization by 46% compared with placebo.