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Published on 27 April 2010

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CRESTOR(TM) Gains New EU Indication

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CRESTOR(TM) (rosuvastatin) has been approved in nineteen countries within the EU for the prevention of major cardiovascular events in patients who are at high risk of having a first cardiovascular.

This new indication is based on subgroup data from the landmark JUPITER study, which evaluated the impact of rosuvastatin 20 mg on reducing major cardiovascular events in a previously unstudied population. A post-hoc analysis of this subgroup data showed a significant reduction in the combined endpoint of heart attacks, strokes and CV deaths amongst the high risk patients within JUPITER.

“This new indication is a significant milestone and means that rosuvastatin can now be prescribed to high risk patients to prevent CV events including heart attacks and strokes,” said Michael Cressman, Executive Director of Clinical Research for CRESTOR.  “Clinical studies have previously shown that rosuvastatin was the most effective statin at lowering LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, an underlying cause of cardiovascular disease.”

In JUPITER, rosuvastatin 20 mg was well tolerated in nearly 9,000 patients. There was no difference between treatment groups for major adverse events. There was a small increase in physician reported diabetes which is in line with data from other large placebo controlled statin trials. This finding has been reflected in the updated Summary of Product Characteristics (SmPC).

Crestor



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