CRESTOR (rosuvastatin) shown to significantly reduce risk of venous thromboembolism

Mar 29 2009

A new analysis from the JUPITER study shows that CRESTOR (rosuvastatin) 20mg significantly cut the risk of venous thromboembolism (VTE) by 43% (p=0.007) compared to placebo among men and women with low to normal cholesterol levels and elevated high-sensitivity C-reactive protein (hsCRP).

This analysis was presented today at the 58th Annual American College of Cardiology Scientific Sessions (ACC), in Orlando Florida, and published simultaneously in the New England Journal of Medicine.

Venous thromboembolism, a serious and sometimes fatal condition, occurs when a blood clot forms in a vein. The most common form of VTE is deep vein thrombosis (DVT), which usually occurs in the 'deep veins' in the legs or pelvis. An embolism is created if the clot travels through the venous system. Blood clots lodging in the lungs are known as a pulmonary embolism (PE). Estimates suggest that at least 350,000 and as many as 600,000 Americans annually contract DVT/PE, and at least 100,000 deaths are thought to be related to these diseases each year.

Additional results of this secondary endpoint analysis of JUPITER showed rosuvastatin 20mg produced a significant 55% (p=0.004) reduction in the risk of DVT and a non-significant 23% reduction in PE (p=0.42).

"This is the first time a statin has been shown to reduce the risk of VTE in a large, randomized, prospective study," said Michael Cressman, AstraZeneca's Medical Science Director for CRESTOR, "This observed benefit appears to be additional to the reduction in CV events already demonstrated by rosuvastatin in the primary analysis of JUPITER."

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 or venous thromboembolism. 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.

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.