The STELLAR study (Statin Therapies for Elevated Lipid Levels compared Across doses to Rosuvastatin) is a six-week, randomized, open-label study comparing the efficacy, as an adjunct to diet, of specific doses and the dose range of CRESTOR with specific doses and the dose ranges of atorvastatin, pravastatin and simvastatin in patients with primary hypercholesterolemia. "STELLAR reinforces what we have learned from previous clinical trials of CRESTOR," said Peter Jones, MD, associate professor of medicine at Baylor College of Medicine and lead investigator of the STELLAR trial.
In STELLAR, 2431 patients with hypercholesterolemia (LDL-C ≥ 160 mg/dL and < 250 mg/dL; triglycerides < 400 mg/dL) were randomized to one of 15 open-label treatment arms for six weeks. CRESTOR 10-40 mg reduced LDL-C by 46 to 55 percent compared with 37 to 51 percent for atorvastatin 10-80 mg, 28 to 46 percent for simvastatin 10-80 mg, and 20 to 30 percent for pravastatin 10-40 mg. The study also showed that CRESTOR 10-40 mg raised HDL-C by 7.6 to 9.6 percent compared with 5.7 to 2.0 percent for atorvastatin 10-80 mg, 5.3 to 6.8 percent for simvastatin 10-80 mg, and 3.2 to 5.5 percent for pravastatin 10-40 mg. In STELLAR, CRESTOR was generally well tolerated. The most common adverse events in the study were pain, pharyngitis, myalgia and headache.
The GALAXY Program
The STELLAR study is one of the many trials included in AstraZeneca’s GALAXY Program. The GALAXY Program is designed to address important unanswered questions in statin research and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes. Currently, 2 studies have completed and 9 are ongoing and more than 19,000 patients have been recruited from 23 countries worldwide.
About CRESTOR®
CRESTOR belongs to the class of lipid-lowering medications called HMG- CoA reductase inhibitors, or "statins." AstraZeneca licensed worldwide rights to CRESTOR
from the Japanese pharmaceutical company Shionogi & Co., Ltd.. CRESTOR was first approved in the Netherlands in 2002 and approval has recently been granted in 13 other European countries - Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Portugal, Sweden and United Kingdom. CRESTOR is also approved in Canada and Singapore, and is awaiting approval in the USA, Japan and in other markets.
About AstraZeneca
AstraZeneca (AZN: NYSE) 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 top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of cardiovascular, gastrointestinal, oncology, anesthesia (including pain management), central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is a $9.3 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
Contact: Gary Bruell
AstraZeneca LP
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gary.bruell@astrazeneca.com
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