CRESTOR European Prescribing Information Changes

Main Category: Statins
Article Date: 10 Jun 2004 - 19:00 PDT

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CRESTOR 10-40 mg gets more patients to their LDL-C goal than any other currently marketed statin, is well tolerated and has a safety profile similar to that of other statins when used according to the prescribing information.

At the request of European regulatory authorities AstraZeneca has today written to healthcare professionals across Europe detailing changes in the prescribing information which relate to the use of CRESTOR 40mg (the highest dose) in the very small proportion of patients who require this dose* and, specifically, that smaller group who have predisposing factors for myopathy/rhabdomyolysis and are therefore at the highest risk of developing the adverse muscle events seen rarely with all statins.

This change was requested, following a review of the latest European post-marketing surveillance data on CRESTOR, which highlighted that the few cases of rhabdomyolysis, seen in Europe, have occurred in patients who received higher than the recommended starting dose of CRESTOR, many of whom also had predisposing factors for myopathy/rhabdomyolysis.** In the current cautious environment around statins, the re-wording of the European prescribing information will clarify the use of CRESTOR to ensure that preventative steps are taken to minimise the risk of patients developing myopathy/rhabdomyolysis.

AstraZeneca wants to ensure that CRESTOR is used both safely and effectively and believes that, whilst appropriate caution should be used when titrating CRESTOR to its highest approved dose (40mg), the proven clinical benefit of this treatment in patients with previously uncontrollable and potentially life threatening lipid disorders, make it an important, clinically useful and effective medicine for the prevention of cardiovascular disease.

Extensive clinical trials in more than 40,000 patients and post-marketing surveillance of more than 5 million prescriptions in almost 2 million patients demonstrate that CRESTOR is very effective (more than 80% of patients reach their cholesterol goals at the 10mg starting dose) and has a safety profile similar to that of other statins in real world use.

* Approximately 4% of current usage in Europe
** Across the stain class, muscle toxicity is a recognised, dose-related, adverse reaction, leading in rare cases to rhabdomyolysis.

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http://www.astrazeneca.com

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