Pharmaceutical Business review

AstraZeneca’s Crestor reduces cardiovascular risk in statin outcomes study

Results also showed that for patients in the trial taking rosuvastatin: the combined risk of heart attack, stroke or cardiovascular (CV) death was reduced by nearly half (47%, p<0.001), risk of heart attack was cut by more than half (54%, p<0.001), risk of stroke was cut by nearly half (48%, p=0.002) and total mortality was significantly reduced by 20% (p=0.02). These results were accompanied by a median LDL-C reduction of 50% (p<0.001) resulting in an on-treatment median LDL-C of 55 mg/dL, the company said. According to the company, Rosuvastatin 20mg was well tolerated in nearly 9,000 patients during the course of the study. There was no difference between treatment groups for major adverse events, including cancer or myopathy. There was a small increase in physician reported diabetes consistent with data from other large placebo controlled statin trials. AstraZeneca expects to file a regulatory submission including the Jupiter data in the first half of 2009 and if approved, will begin promotional activities within the approved labeling. Howard Hutchinson, chief medical officer of AstraZeneca, said: "These results provide new information about Crestor's effects on CV risk. The Jupiter trial confirmed that Crestor reduces LDL-C cholesterol levels and has now demonstrated a nearly 50% reduction in the risk of heart attack and stroke in a population of patients who had elevated high sensitivity C-reactive protein but low to normal cholesterol levels. "As is appropriate, the medical community, regulators, and guideline committees will now carefully consider these data and any implications for treating patients."