Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-induced Myotoxicity

The aim of this study is to investigate whether the pharmacokinetics of atorvastatin and/or its metabolites is altered in patients with confirmed atorvastatin-induced myopathy compared to healthy controls.

A 24 hour pharmacokinetic investigation of atorvastatin and metabolites will be performed in 15 patients with a history of atorvastatin -induced myotoxicity. The possible link to relevant mutations in SLCO1B1, CYP3A5 and MDR1 will be also be investigated

Inclusion Criteria:

• above 18 years
• previous history of atorvastatin-associated myotoxicity

Exclusion Criteria:

• current treatment with drugs or herbal remedies with known pharmacokinetic interaction potential with atorvastatin
• previous CK levels above ten times the upper limit of normal range
• pregnancy and persistent muscular complaints after a four week wash-out period of statin treatment