The Association of Genetic Polymorphisms With Statin-Induced Myopathy.

• Conditions: Rhabdomyolysis; Myopathy
• Interventions: Genetic: DNA

• Registration Number: NCT00549029
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

To observe not only the distribution of single nucleotide polymorphism in genes related with pharmacodynamic and pharmacokinetics alteration of statins but also to analyze the correlation between these SNPs and the incidence of statins-induced myopathy.

Detailed Description

Statins are widely prescribed for the patients with hypercholesterolemia.

Though their efficacy in preventing cardiovascular events has been shown by a large number of clinical trials, myotoxic side effects including myopathy or even more severe,rhabdomyolysis are associated with the use of statins.

Because the incidence of myopathy is various among individuals,polymorphism in genes is supposed to be the main factor.

Due to single nucleotide polymorphism in related genes,level of uptake, clearance and metabolism of statins can be seriously different among individuals resulting in various occurrence of myopathy.

Therefore, analytical study in association between SNP of statins-related genes and the incidence of myopathy is such a critical research which can be applied into clinical fields.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-08
• Status Verified: 2007-10
• Study First Submitted: 2007-10-24
• Study First Submitted QC: 2007-10-24
• Last Update Submitted: 2007-10-24
• Study First Posted: 2007-10-25
• Last Update Posted: 2007-10-25
• Study Completion: 2008-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Clinical diagnosis of Rhabdomyolysis because of prescription with statins

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Exclusion Criteria

• Carnitine palmityl transferase ll deficiency
• McArdle disease
• Myoadenylate deaminase deficiency

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1,2	DNA	Group 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy

Primary Outcome Measures

Name	Time	Method
genotype of specific genes	one day

Secondary Outcome Measures

Name	Time	Method
single nucleotide polymorphism	one day

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan