Circulation Study on Crestor 'Misleading,' AstraZeneca Says

AstraZeneca doesn't intend to alter its marketing strategy for Crestor in light of a newly published postmarket analysis that indicates the drug might cause more adverse side effects than other statins.

"We're not going to be doing anything differently," according to a company spokeswoman, who said that the study is misleading and that AstraZeneca believes Crestor (rosuvastatin calcium) is safe and effective when used according to prescribing information.

The postmarket study in question -- to be published in the June 14 issue of Circulation: Journal of the American Heart Association -- found that patients taking Crestor are more likely to develop serious side effects, such as renal failure or the muscle-wasting disease rhabdomyolysis, than patients taking Pravachol (pravastatin sodium), Lipitor (atorvastatin calcium) or Zocor (simvastatin).

Based on adverse-event reports submitted to the FDA through September 2004, the analysis showed Crestor patients are eight times more likely to develop serious complications than patients taking Pravachol, and 6.5 times more likely than patients taking Lipitor. The adverse-event risk was 2.2 times higher in Crestor compared to Zocor.

The study's findings are at odds with the most recent safety evaluation from the FDA, which in March declared that Crestor poses no greater safety risks than other approved statins. The agency based its conclusion on a detailed review of all available safety information, including the same adverse-event reporting data analyzed by the Circulation study.

To view the Circulation study, go to ()a href="http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.105.555482v1" target="_blank">http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.105.555482v1