April 27, 2010 – A popular statin gained a new indication today in the European Union for prevention of major cardiovascular events in patients who are at high risk of having a first cardiovascular event.
This new indication for Crestor (rosuvastatin) is based on subgroup data from the landmark JUPITER study, which evaluated the impact of rosuvastatin 20 mg on reducing major cardiovascular events in a previously unstudied population. A post-hoc analysis of this subgroup data showed a significant reduction in the combined endpoint of heart attacks, strokes and cardiovascular deaths amongst the high-risk patients within JUPITER.
This new indication allows rosuvastatin to be prescribed to patients to prevent cardiovascular events, including heart attacks and strokes. Clinical studies have previously shown rosuvastatin was effective at lowering low-density lipoprotein cholesterol (LDL-C), had a significant effect on raising high-density lipoprotein cholesterol (HDL-C) and slowed the progression of atherosclerosis.
In JUPITER, rosuvastatin 20 mg was well tolerated in nearly 9,000 patients. There was no difference between treatment groups for major adverse events. There was a small increase in physician reported diabetes, which is in line with data from other large placebo controlled statin trials.
High-risk patients were defined in the study as having a Framingham risk score more than 20 percent
The JUPITER Trial
JUPITER was a long-term, randomized, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20 mg decreased the risk of heart attack, stroke and other 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 was stopped early by the Data Safety Monitoring Board due to meeting predefined stopping rules for efficacy in patients treated with Crestor. There was a small increase in physician reported diabetes (2.8 percent in patients taking Crestor vs. 2.3 percent in patients taking placebo) observed in the JUPITER trial.
JUPITER is a part of AstraZeneca's extensive GALAXY clinical trials program, designed to address unanswered questions in statin research. Currently, more than 65,000 patients have been recruited from 55 countries worldwide to participate in GALAXY.
Crestor has received regulatory approval in more than 100 countries, and 19 million patients have been prescribed the drug 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.com