February 09, 2010
Crestor approved for cardiovascular risk reductionThe FDA has approved Crestor (rosuvastatin calcium tablets, from AstraZeneca) to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD). An increased risk of CVD is based on age (≥50 years for men, ≥60 years for women), a high-sensitivity C-reactive protein ≥2mg/L, and the presence of at least one additional CVD risk factor (eg, hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease).
This 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 CVD events. In the study, Crestor significantly 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) versus placebo.
Crestor is already indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. Crestor is also indicated as an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.
For more information call (800) 237-8898 or visit www.crestor.com.