AstraZeneca announced the launch of a new clinical trial, SATURN, designed to measure the impact of CRESTOR™ (rosuvastatin) 40 mg and atorvastatin (Lipitor®) 80 mg on the progression of atherosclerosis in high risk patients. SATURN will compare the effects of these two statins on the ability to decrease progression or induce regression of atherosclerosis, the main cause of cardiovascular disease, following two years of treatment in patients with coronary artery disease.
"The impact on atherosclerosis has been studied previously in separate clinical trials involving rosuvastatin and atorvastatin," said Elisabeth Bjork, Global Medical Science Director for CRESTOR, "This study, for the first time, will provide physicians with important information to better understand how these two statins compare when treating dyslipidaemic patients with advanced atherosclerosis."
SATURN, (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN), is a 104-week, parallel-group, multicentre, double-blind, Phase IIIb intravascular ultrasound (IVUS) imaging study of approximately 1,300 patients at 170 centres worldwide. The first patient will be enrolled later this month and the study is expected to complete in 2011. SATURN is part of AstraZenecaâs extensive GALAXY clinical trials programme, designed to address important unanswered questions in statin research and to investigate the impact of rosuvastatin on control of lipids, atherosclerosis and cardiovascular morbidity and mortality. Currently, more than 63,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.
"Two major studies in the GALAXY programme have already demonstrated the significant impact of rosuvastatin 40mg on atherosclerosis across the disease spectrum. The ASTEROID study was the first to show regression of coronary atherosclerosis in patients with established disease, and the METEOR study showed that rosuvastatin can also slow or delay the progression of carotid atherosclerosis in patients with early signs of the disease. The results of the SATURN study will provide additional information on how best to treat patients with the very serious condition of advanced atherosclerosis," said Elisabeth Bjork. "We believe the data from this study will underscore the benefits of intensively managing cholesterol levels with rosuvastatin, both LDL-C and HDL-C, to reduce the burden of atherosclerosis."
Data from other atherosclerosis trials in the GALAXY programme, METEOR and ASTEROID, have demonstrated that intensive treatment with Rosuvastatin 40mg results in effective lipid management and beneficial effects across the atherosclerotic disease spectrum:
- METEOR was the first study to show that rosuvastatin demonstrated a positive effect on atherosclerosis in people at low risk of coronary heart disease (CHD) and with early signs of carotid artery disease as measured by B-mode ultrasound.
- ASTEROID demonstrated that rosuvastatin regressed atherosclerosis as measured by intravascular ultrasound (IVUS) in high risk patients with evidence of coronary artery disease by coronary angiography.
In the U.S., based on the METEOR study, rosuvastatin has been approved as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. The rosuvastatin Prescribing Information in Europe has been updated to incorporate data from the METEOR study.
CRESTOR has now received regulatory approvals in over 90 countries. Over 11 million patients have been prescribed rosuvastatin worldwide. Global sales of CRESTOR for the first nine months of 2007 were $1,997 million - an increase of 30 per cent on the same period of 2006. Data from clinical trials and real world use shows that the safety profile for rosuvastatin is in line with other marketed statins.
The 40 mg dose is the highest registered dose of rosuvastatin. 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 10mg. The 40mg dose should only be used in patients who have not achieved their LDL-C goal utilising the 20mg dose of rosuvastatin.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.