The trial was based on age (men= 50 and women= 60), high-sensitivity C-reactive protein (hsCRP) = 2mg/l, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease.
The FDA approval was based on data from the JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study, which evaluated the impact of Crestor 20mg on reducing major cardiovascular (CV) events in a previously unstudied population. In JUPITER, Crestor reduced the relative risk of heart attack by 54% (p<0.001), stroke by 48% (p=0.002), and arterial revascularization by 46% (p<0.001) vs placebo.
Howard Hutchinson, chief medical officer of AstraZeneca, said: “Not only is this approval a significant milestone for AstraZeneca, but it is also important for the patients who could now benefit from Crestor therapy under this approved indication. This new indication adds to the significant body of evidence physicians use to evaluate Crestor as a treatment option.”