First Head to Head Study Comparing CRESTOR and LIPITOR®

AstraZenecaAstraZeneca 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 AstraZeneca’s 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.

Most Popular Now

COVID-19 can trigger self-attacking antibodies

Infection with the virus that causes COVID-19 can trigger an immune response that lasts well beyond the initial infection and recovery - even among people who had mild sy...

Stopping dementia at the nose with combination of …

Dementia is thought to occur when proteins called amyloid-β, tau, and α-synuclein accumulate in the brain and form oligomers. A research group from the Department of Tran...

Treatments in weeks, not months: Scientists develo…

An international team of scientists has created a plan for an accelerated pipeline for developing drug cocktails to battle the COVID-19 pandemic. The pipeline could speed...

COVID-19 - Omicron: resistant to most monoclonal a…

The Omicron variant was detected for the first time in South Africa in November 2021 and has since spread to many countries. It is expected to become the dominant variant...

Scientists identify antibodies that can neutralize…

An international team of scientists have identified antibodies that neutralize omicron and other SARS-CoV-2 variants. These antibodies target areas of the virus spike pro...

Pfizer and BioNTech sign new global collaboration …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a new research, development and commercialization collaboration to develop a potential first mRNA-based v...

Novartis and Molecular Partners report positive to…

Novartis and Molecular Partners announced that Part A of the EMPATHY clinical trial(1) that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic...

Bayer and Mammoth Biosciences to collaborate on no…

Bayer AG and Mammoth Biosciences, Inc., which is harnessing the diversity of nature to power the next-generation CRISPR products, today announced a strategic collaboratio...

Amgen and Arrakis Therapeutics announce multi-targ…

Amgen (NASDAQ:AMGN) and Arrakis Therapeutics today announced a research collaboration focused on the discovery and development of RNA degrader therapeutics against a rang...

Leiden University Medical Center and Intravacc to …

Intravacc, a global leader in translational research and development of therapeutic vaccines and vaccines against infectious diseases, today announced a partnership with ...

New Vaxzevria data further support its use as thir…

Positive results from a preliminary analysis of an ongoing safety and immunogenicity trial (D7220C00001) showed that Vaxzevria (ChAdOx1-S [Recombinant]), when given as a ...

AstraZeneca and Ionis close agreement to develop a…

AstraZeneca has closed a global development and commercialisation agreement with Ionis Pharmaceuticals, Inc. (Ionis) for eplontersen, formerly known as IONIS-TTR-LRX. ...