CRESTOR is well tolerated and has a favourable benefit-risk profile to that of other marketed statins [38]

Additionally as CRESTOR is not metabolised by the CYP450 3A4 pathway it has a lower potential for drug interactions.

The tolerability profile of CRESTOR has been well-researched in a large number of patients representing ‘real population’:

• an extensive clinical trial program with >55,000 rosuvastatin treated patients38, 39
• post-marketing surveillance in >12 million patients40
• three large, independently conducted ‘real-life’ studies including >30,000 rosuvastatin treated patients in the USA, Netherlands and UK41-43

The Rosuvastatin Clinical Development Programme (n=12,400) included a wide range of patients treated with rosuvastatin 5-40 mg, including many at increased cardiovascular risk, reflecting those seen in general medical practice. The programme found that:

• Rosuvastatin is generally well tolerated with an adverse event profile similar to currently marketed statins
• Most common related adverse events - myalgia, asthenia, abdominal pain, nausea; these are generally mild and transient
• Well tolerated regardless of age, sex, ethnicity, presence of co-morbidities or concomitant medications
• Similar number of adverse events leading to withdrawal as other currently marketed statins

Patients not withdrawing from clinical studies due to an adverse event

Like all statins, CRESTOR is well tolerated.  Around 97% of patients in the clinical trials programme remained within the trials. This was similar for all the statins evaluated. 

The safety profile of CRESTOR has also been supported by a real-world pharmacoepidemiology programme in over 30,000 CRESTOR patients, and post-marketing surveillance of over 12 million patients taking CRESTOR.