The MHRA has issued a warning about the increased risk of myopathy with high-dose simvastatin (80mg). The advice follows a review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) which indicated that there was a greater risk of myopathy with simvastatin 80mg versus simvastatin 20mg without any significant benefits.
The advice states that:
- Simvastatin 80mg should be considered only in patients with severe hypercholesterolaemia and high risk of cardiovascular complications who have not achieved their treatment goals on lower doses, when the benefits outweigh the risks.
- Prescribers treating patients taking simvastatin 80mg or who are being considered for a dose increase should review this decision.
- Patients currently taking simvastatin 80mg should not stop taking their medicine but should be advised to inform their doctor if they experience any signs of myopathy.