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Stabroek News

Study on statins begins
published: Wednesday | March 26, 2008

PORT OF SPAIN, Trinidad and Tobago:

Astrazeneca has announced the launch of a new clinical trial, SATURN, designed to assist physicians in the treatment of coronary artery disease. The study will measure the impact of Crestor (rosuvastatin) 40mg and atorvastatin (Lipitor) 80mg on the progression of atherosclerosis or hardening of the arteries, 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. Statins are a class of drugs used to lower cholesterol levels in people with or at risk of cardiovascular disease.

"The impact of atherosclerosis has been studied previously in separate clinical trials involving rosuvastatin and atorvastatin," said Elizabeth Bjork, Global Medical Director for Crestor. "This study, for the first time, will provide physicians with important information to better understand how these two statins compare with treating patients with advanced atherosclerosis."

SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin), is a 104 week study of approximately 1,300 patients at 170 centres worldwide. The study is expected to be completed in 2011.

SATURN is part of AstraZeneca's extensive GALAXY clinical trials programme, designed to address important unanswered questions in statin research. It will also investigate the impact of Crestor 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.

Significant impact

"Two major studies in the GALAXY programme have already demonstrated the significant impact of Crestor40mg 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 Crestor 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. In the US, Crestor has been approved to be administered together with diet to slow the progression of atherosclerosis in patients with elevated cholesterol. The Crestor 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 Crestor worldwide. Data from clinical trials and real world use show that the safety profile for Crestor is in line with other marketed statins.

Source: Astrazeneca

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