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

Phase 4CompletedNCT00120055

University of Oslo School of Pharmacy

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Myopathy

Interventions

Atorvastatin (Lipitor)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Statin toxicity

Rechallenge test of statin induce toxicity

Time frame: 1 year

Data from ClinicalTrials.gov

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