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

University of Oslo School of Pharmacy

Status and phase: Completed; Phase 4

Conditions: Myopathy

Treatments: Drug: Atorvastatin (Lipitor)

Study type: Interventional

Funder types: Other

Identifiers

NCT00120055

AVALIP04

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)