Rosuvastatin - starting and switching to

When starting treatment with rosuvastatin or switching a patient from another statin to rosuvastatin then (1,2):

• all patients (including those who are switching form another statin) must start on the initial dose of 5 mg (or 10mg) of rosuvastatin once daily and should only be titrated to a higher dose after a 4 week trial
  • the recommended start dose is 5 mg or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions (2)
  • 5mg starting dose is recommendedas the starting dose in Asians (who experience higher plasma levels of rosuvastatin than Caucasians) and patients with pre-disposing factors for myopathy, which include (4):
    • moderate renal impairment (creatinine clearance < 60 ml/min)
    • hypothyroidism
    • personal or family history of hereditary muscular disorders
    • previous history of muscle toxicity with another HMG-CoA reductase inhibitor or fibrate
    • alcohol abuse
    • patients > 70 years of age
    • concomitant use of fibrates
    • other patients may be started on either 5 mg or 10 mg depending on cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions
• the 40mg dose is contraindicated in patient swith predisposing risk factors for myopathy/rhabdomyolysis
• specialist supervision is recommended when the 40 mg dose is initiated (through local lipidology, diabetic or cardiac clinics). The 40 mg dose should only be necessary for the minority of patients with severe hypercholesterolaemia at high cardiovascular risk
• patients who are currently taking 40mg and who have not already been seen by a specialist should have their treatment reviewed at their next routine appointment and appropriate down-titration of dose or specialist referral should be considered

"A review of reports of rhabdomyolysis with rosovastatin has raised concern about the risk of rhabdomyolysis with doses above 20mg, particularly in patients with pre-disposing factors or with doses above 20mg rosuvastatin and with concomitant use of fibrates. Where cases of rhabdomyolysis have been reported in association with the use of rosuvastatin, the majority of cases have involved patients who had pre-disposing factors for myopathy or had started treatment on a dose of > 10mg. (1)"

Note also that 40mg dose is specifically contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis(2). Such factors include:

• moderate renal impairment (creatinine clearance < 60 ml/min)
• hypothyroidism
• personal or family history of hereditary muscular disorders
• previous of family history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
• alcohol abuse
• situations where an increase in plasma levels may occur
• Asian patients
• concomitant use of fibrates

Consult the summary of product characteristics before prescribing rosuvastatin.

Reference:

1. AstraZeneca UK Limited (June 2004). Rhabdomyolysis. Crestor (rosuvastatin) - important changes in prescribing information.
2. AstraZeneca UK Limited (October 2005). Crestor (rosuvastatin) - summary of product characteristics update.
3. AstraZeneca UK Limited (January 2005). Important information - summary of product characteristics update.
4. Current Problems in Pharmacovigilance (2006);31:1-12.