Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity

Phase 4CompletedNCT00199745

Oslo University Hospital53 enrolled

Overview

The primary objective of the study is to investigate whether differences in atorvastatin metabolite ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.

The primary objective of the study is to investigate whether differences in atorvastatin metabolites ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Muscular Diseases

Interventions

atorvastatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Suspected atorvastatin induced muscle adverse events * Signed informed consent * 18 years of age or older * Able to donate blood samples * Ongoing treatment with atorvastatin (not necessary if patients only donate a muscle biopsy)

Locations (1)

Lipidklinikken, Rikshospitalet-Radiumhospitalet HF

Oslo, Oslo County, Norway

Outcomes

Primary Outcomes

To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers

Secondary Outcomes

Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group

Data from ClinicalTrials.gov

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