CRESTOR Reduced Risk of Cardiovascular Events in Elderly in New Analysis of JUPITER Study
September 2, 2009 – A new analysis from the JUPITER study showed CRESTOR (rosuvastatin calcium) 20 mg reduced the composite primary end point of major cardiovascular (CV) events (myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by 39 percent, compared to placebo, in elderly patients with LDL-C less than 130 mg/dL and elevated high-sensitivity C-reactive protein (hsCRP).
This analysis was conducted in 5,695 patients age 70 or older. The results from this analysis are consistent with the CV risk reduction seen across all patients taking rosuvastatin in the primary JUPITER analysis. These data were presented Monday at the European Society of Cardiology (ESC) meeting in Barcelona, Spain.
Additional results from this analysis showed that treatment with CRESTOR vs. placebo found:
• Reduced the combined risk of cardiovascular death, heart attack and stroke by nearly 40 percent.
• Reduced the risk of heart attack by 45 percent and of stroke by 45 percent.
• Reduced the need for hospitalization for arterial revascularization or unstable angina by 49 percent.
• Treatment effects, relative to placebo, were generally comparable in both the elderly (aged 70 or older) and younger patient groups.
AstraZeneca filed a regulatory submission with the FDA, including the JUPITER data, in the first half of 2009.
Results from the primary analysis of JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin), originally presented in November 2008 at the American Heart Association's Annual Scientific Sessions, and published by the New England Journal of Medicine. JUPITER 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 LDL-C < 130 mg/dL but at increased cardiovascular risk as identified by age and elevated high-sensitivity C-reactive protein (hsCRP). 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 program, 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 Program.
Studies have previously shown that CRESTOR, as an adjunct to diet in adult patients, significantly lowered 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 17 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.
For more information: www.astrazeneca-us.com
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