New Safety Paper Confirms Crestor is Well Tolerated Across Dose Range
February 17, 2017
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: rosuvastatininformation
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 crestor.
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: astrazeneca-us
Media contacts
Emily Denney
AstraZeneca
302-885-3451
View drug information on Crestor; Warfarin Sodium tablets.