New Safety Paper Confirms Crestor is Well Tolerated Across Dose Range

Main Category: Statins
Article Date: 08 Oct 2004 - 15:00 PDT

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Wilmington, DE - Further evidence that the safety and tolerability of CRESTOR® (rosuvastatin calcium), is in line with the other marketed statins was published on October 1st in the American Journal of Cardiology. Extensive data taken from over 12,000 patients who received CRESTOR 5-40mg in phase II and III studies, have once again confirmed that the efficacy benefits of CRESTOR relative to other statins, with an adverse event profile similar to other leading statins.

AstraZeneca also announced today that it has published company-sponsored clinical trial and post marketing safety data about CRESTOR on the Internet. The site is intended to provide a comprehensive, scientific summary of information about CRESTOR.

The rosuvastatin clinical trial registry provides an easily accessible source of data from AstraZeneca-sponsored clinical trials with CRESTOR. AstraZeneca is committed to the ethical conduct of clinical research, and to facilitating full and open access to the findings of this research. Therefore, access to this registry is unrestricted, following acceptance of terms and conditions.

The site is now live and available via the AstraZeneca corporate website: http://www.rosuvastatininformation.com

The full paper by Shepherd et al is available via the AstraZeneca clinical trials registry website, however, key findings were:

-- In fixed-dose trials with comparator statins CRESTOR 5 to 40 mg showed a similar adverse event profile to those for atorvastatin 10 to 80 mg, simvastatin 10 to 80 mg, and pravastatin 10 to 40 mg

-- Clinically significant elevations in alanine aminotransferase (>3 times the upper limit of normal [ULN]) and creatine kinase (>10 times ULN) were uncommon (0.2%) in the CRESTOR and comparator statin groups

-- Dipstick-positive proteinuria at rosuvastatin doses £40 mg was comparable to that seen with other statins, and the development of proteinuria was not predictive of acute or progressive renal disease

-- No deaths in the program were attributed to CRESTOR

-- No rhabdomyolysis occurred in patients receiving CRESTOR 5 to 40 mg

CRESTOR is now approved in 64 countries worldwide and is taken by more than three million patients to reduce their LDL-C. Over 10 million prescriptions have now been written for CRESTOR worldwide.

People with raised levels of LDL-C are predisposed to cardiovascular disease, which kills over 17 million people worldwide each year.

About CRESTOR®

CRESTOR (rosuvastatin calcium) is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.

In clinical studies, CRESTOR was generally well-tolerated. The most common side effects are muscle pain, constipation, weakness, stomach pain and nausea. These are usually mild and tend to go away. Doctors will perform blood tests before and during treatment with CRESTOR to monitor for liver function. Patients are encouraged to tell their doctor if they are taking any medications, including cyclosporine, warfarin, gemfibrozil or antacids. CRESTOR is not right for everyone, including women who are nursing, pregnant, or who may become pregnant, or anyone with liver problems. Unexplained muscle pain, tenderness or weakness could be a sign of a rare but serious side effect and should be reported to a doctor right away. CRESTOR has not been determined to prevent heart disease, heart attacks, or strokes.

Full prescribing and product information for CRESTOR is available by calling the AstraZeneca Information Center at 1-800-236-9933 or by visiting http://www.crestor.com.

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 over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 11,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com

Media contacts
Emily Denney
AstraZeneca
302-885-3451