Crestor Shows Dramatic Cardiovascular Risk Reduction
New data from the JUPITER study demonstrated that Crestor (rosuvastatin calcium) 20 mg significantly reduced major cardiovascular (CV) events (defined in this study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by a dramatic 44% compared to placebo (p<0.001) among men and women with elevated hsCRP but low to normal cholesterol levels.
Results of the Crestor study also showed that for patients in the trial taking rosuvastatin:
the combined risk of heart attack, stroke or 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).
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.
On the basis of the data, if the results are projected over a period of 5 years, 25 patients would need to be treated to prevent one major cardiovascular event (NNT=25).
The JUPITER results will be presented today at the American Heart Association Scientific Sessions and were simultaneously published online by the New England Journal of Medicine.
"These results provide new information about Crestor’s effects on cardiovascular risk. The JUPITER trial confirmed that CRESTOR dramatically 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 hsCRP but low to normal cholesterol levels,” said Howard Hutchinson, Chief Medical Officer for AstraZeneca. "As is appropriate, the medical community, regulators, and guideline committees will now carefully consider these data and any implications for treating patients."
As previously guided, 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.
Rosuvastatin is not indicated for the prevention of cardiovascular events. Rosuvastatin should be used according to the prescribing information, which contains recommendations for initiating and titrating therapy according to the individual patient profile. In most countries, the usual recommended starting dose of rosuvastatin is 10 mg.
Rosuvastatin 20 mg 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.
JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was a long-term, randomized, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20 mg decreases the risk of heart attack, stroke and other major cardiovascular events in patients with low to normal LDL-C but at increased cardiovascular risk as identified by elevated high-sensitivity C-reactive protein (hsCRP) and age. The majority of patients had at least one other risk factor including hypertension, low HDL-C, family history of premature coronary heart disease (CHD) or smoking. hsCRP is a recognized marker of inflammation which is associated with an increased risk of atherosclerotic cardiovascular events.
JUPITER is a part of AstraZeneca’s extensive GALAXY clinical trials programme, designed to address important unanswered questions in statin research. Currently, more than 69,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.
ABOUT CRESTOR (ROSUVASTATIN):
Studies have previously shown that CRESTOR 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.
CRESTOR has now received regulatory approval in over 95 countries. Nearly 15 million patients have been prescribed CRESTOR worldwide. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with other marketed statins.