AstraZeneca's CRESTOR: Health Canada approves new indication

Approval based on JUPITER trial which demonstrated reduction of cardiovascular events by nearly half

AstraZeneca announced today that Health Canada has approved CRESTOR (rosuvastatin calcium) to reduce the risk of nonfatal myocardial infarction (heart attack), nonfatal stroke, and coronary artery revascularization in adult patients without documented history of cardiovascular or cerebrovascular events, but with at least two conventional risk factors for cardiovascular disease.

The new CRESTOR indication for prevention of major cardiovascular events is based on data from the landmark JUPITER trial (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) which demonstrated that CRESTOR 20mg significantly reduced the relative risk of nonfatal heart attack by 65% (p(less than)0.00001), non fatal stroke by 48%>

"The JUPITER trial was significant because it challenged previous thinking about cardiovascular disease. The trial demonstrated that even people with low to normal LDL may still be at risk of a cardiovascular event," said Dr. Jacques Genest, Director, Cardiology Division, McGill University Health Centre. "In addition to the benefits we witnessed, when significant LDL lowering was achieved, the JUPITER trial also suggests that people with high hsCRP and two or more risk factors may be able to reduce their risk of cardiovascular events with effective treatments."

Cardiovascular disease is the leading cause of death in Canada, yet nearly one half of all cardiovascular events occur in patients who have low or normal levels of LDL-C, a traditional indicator of cardiovascular risk.

"This indication is important because it provides physicians with greater clarity when determining treatment options for their patients at risk of cardiovascular disease," says Catriona McMahon, Vice President Medical Affairs, AstraZeneca Canada. "AstraZeneca is proud to conduct research such as the JUPITER study because it offers new insights into cardiovascular disease that can ultimately play a role in improving the lives of Canadians."