February 9, 2010 – The FDA approved CRESTOR (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction and arterial revascularization procedures in individuals without clinically evident coronary heart disease. The new indication is for patients with an increased risk of cardiovascular disease (CVD) based on age, high-sensitivity C-reactive, 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 landmark JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study, which evaluated the impact of CRESTOR 20 mg on reducing major cardiovascular (CV) events in a previously unstudied population. In JUPITER, CRESTOR significantly reduced the relative risk of heart attack by 54 percent, stroke by 48 percent and arterial revascularization by 46 percent vs. placebo.
JUPITER included 17,802 men (age 50 and older) and women (age 60 and older) who had no clinically evident cardiovascular disease. The study population had an estimated baseline coronary heart disease risk of 11.6 percent over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58 percent), low HDL-C levels (23 percent), cigarette smoking (16 percent), or a family history of premature CHD (12 percent).
Results from JUPITER were originally presented in November 2008 at the American Heart Association’s Annual Scientific Sessions, and published in the New England Journal of Medicine.
CRESTOR is already indicated in the United States 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: www.astrazeneca.com