Results from a new sub-analysis of the JUPITER study show that patients who attained a dual treatment target of LDL-C <70mg/dL and high-sensitivity C-reactive protein (hsCRP) <2mg/L with CRESTOR (rosuvastatin) 20mg achieved a greater reduction in cardiovascular events compared to placebo than those who did not (65% vs 36%, p=0.033) among men and women with low to normal cholesterol levels and elevated hsCRP.
These new data were presented at the 58th Annual American College of Cardiology Scientific Sessions (ACC) in Orlando, Florida, and published simultaneously in The Lancet.
This analysis was conducted in approximately 15,500 patients, or 87% of the entire JUPITER cohort, representing patients who had LDL-C and hsCRP values assessed at baseline and one year.
Additional results from this analysis showed: -- Patients who achieved an LDL-C <70 mg/dL experienced a 55% reduction in cardiovascular events compared to placebo. -- Patients who achieved a dual treatment target of LDL-C<70 mg/dL and hsCRP <1 mg/L achieved a 79% reduction in CV events compared to placebo.
"These data further support the benefit of achieving low LDL-C with rosuvastatin," said Michael Cressman, AstraZeneca's Medical Science Director for CRESTOR, "Raised LDL-C is one of the major causes of atherosclerosis, an underlying cause of cardiovascular disease. Elevated CRP is a recognized marker of inflammation, so this analysis also suggests that in addition to its lipid lowering properties, CRESTOR may impact another aspect of atherosclerosis, inflammation."
Rosuvastatin 20mg was well tolerated in nearly 9,000 patients during the course of the JUPITER study.
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.
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, showed rosuvastatin 20mg significantly reduced major cardiovascular (CV) events (combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by 44%, compared to placebo (p<0.00001). These results also showed that rosuvastatin 20 mg reduced the combined risk of heart attack, stroke or CV death by nearly half (47%, p<0.00001 vs placebo).
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 low to normal LDL-C 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.
AstraZeneca has previously announced that it 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.
ABOUT CRESTOR (ROSUVASTATIN CALCIUM):
Studies have previously shown that CRESTOR 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 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.