Rosuvastatin approved for patients without heart disease

Last week the FDA approved the cholesterol-lowering medication rosuvastatin (Crestor) for some patients who are at increased risk of heart disease but have not been diagnosed with it.

The drug's new approval now includes men 50 years of age and older and women 60 years of age and older who have an elevated level of high-sensitivity C-reactive protein (CRP) and at least one additional traditional cardiovascular risk factor such as smoking, high blood pressure, a family history of premature heart disease, or low amounts of HDL cholesterol.

The new indication is intended to reduce the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries in patients who have never been diagnosed with heart disease but are at increased risk of a cardiac event, according to an FDA press release. The approval, which was based on the results of JUPITER, does not support use in patients who have an elevated high-sensitivity CRP but no traditional cardiovascular risk factors.