AstraZeneca reported that its statin Crestor™ was sanctioned in 19 EU countries for the prevention of major cardiovascular events in patients who are at high risk of having a first cardiovascular event. Crestor is already approved in various markets worldwide for the treatment of dyslipidemia and hypercholesterolemia and to slow the progression of atherosclerosis.
Crestor is AstraZeneca’s third best-selling pharmaceutical, achieving sales of $4.5 billion in 2009, up 29% on 2008 figures. Approval of the drug for the new indication was based on data from the long-term Jupiter trial, which evaluated whether the drug could decrease the risk of heart attack, stroke, and other cardiovascular events in patients with low to normal LDL-C but who were at increased cardiovascular risk determined by age and elevated high-sensitivity C-reactive protein (hsCRP).
The study, done in over 17,802 patients, was stopped early by the Data Safety Monitoring Board due to meeting predefined stopping rules for efficacy. Results showed that compared with placebo, treatment using Crestor resulted in a 44% reduction in major cardiovascular events in men over 50 years of age and women over 60 years of age with elevated high-sensitivity C-reactive protein but low/normal cholesterol levels.