The Association of Genetic Polymorphisms With Statin-Induced Myopathy.

Overview

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.

Full Title of Study: “Association Analysis Between Single Nucleotide Polymorphisms in Statin-Related Genes and The Incidence of Myopathy Among Statin-Treated Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective

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.

Interventions

  • Genetic: DNA
    • withdraw 5~10mL blood from vein only once during the whole design

Arms, Groups and Cohorts

  • 1,2
    • Group 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy

Clinical Trial Outcome Measures

Primary Measures

  • genotype of specific genes
    • Time Frame: one day

Secondary Measures

  • single nucleotide polymorphism
    • Time Frame: one day

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of Rhabdomyolysis because of prescription with statins Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Overall Official(s)
    • Yen-Hui Chen, PhD, Study Director, National Taiwan Univesity College of Medicine
  • Overall Contact(s)
    • Yen-Hui Chen, PhD, 886-2-2312-3456, tcyhchen@ntu.edu.tw

References

Jisun Oh, et al. Genetic determinants of statin intolerance. Lipid in Health and Disease 2007;6(7). Wei Zhang, et al. Role of BCRP 421C>A polymorphism on rosuvastatin pharmacokinetics in healthy Chinese males. Clinica Chimica Acta 2006;373:99-103. Mikko Niemi, et al. Association of genetic polymorphism in ABCC2 with hepatic multidrug resistance-associated protein 2 expression and pravastatin pharmacokinetics. Pharmacogenetics and Genomics 2006;16:801-808. Andre' BM, et al. Association of polymorphism in the cytochrome CYP2D6 and the efficacy and tolerability of simvastatin. Clin Pharmacol Ther 2001;70:546-551. K. Morimoto, et al. OATP-C(OATPO1B1)15 IS ASSOCIATED WITH LESTEROLEMIC PATIENTS. CLINICAL PHARMACOLOGY THERAPEUTICS 2005;77(2). K. Morimoto, et al. CANDIDATE OF GENETIC MARKERS FOR STATIN-INDUCED MYOPATHY IN JAPANESE PATIENTS WITH HYPERCHOLESTEROLEMIA. Drug Metabolism Reviews 2005;37(4):345.

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