Rosuvastatin's expanded indication draws criticism

April 15, 2010

Following FDA?s expanded indication for rosuvastatin (Crestor, AstraZeneca) in February, the drug?s producer now plans to extend the market for the drug by offering it as a preventive measure to people who do not have cholesterol issues.

Following FDA’s expanded indication for rosuvastatin (Crestor, AstraZeneca) in February, the drug’s producer now plans to extend the market for the drug by offering it as a preventive measure to people who do not have cholesterol issues.

FDA’s recent approval was based on findings from the Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) study. The trial included men aged >50 and women aged >60 with normal cholesterol and a C-reactive protein of 2 or more.

Results indicated that rosuvastatin lowered heart attack risk by 54%, stroke by 48%, and arterial revascularization by 46% among healthy individuals.

Medical experts call into question the propriety of allowing people without cholesterol or heart issues greater use of the drug. Experts contend that a regimen of drugs only will not necessarily prevent disease. However, a balanced diet, weight loss, smoking cessation, and other lifestyle changes can be preventive and carry no risks. Experts also argue that use of the drug will lead only to modest reduction in the number of strokes, heart attacks, or deaths in the United States.

Potential side effects of rosuvastatin include muscle aches, liver problems, and greater risk of type 2 diabetes.