Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-induced Myotoxicity
Phase 4
Completed
- Conditions
- Myopathy
- Registration Number
- NCT00120055
- Lead Sponsor
- University of Oslo School of Pharmacy
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Statin toxicity 1 year Rechallenge test of statin induce toxicity
- Secondary Outcome Measures
Name Time Method