The Association of Genetic Polymorphisms With Statin-Induced Myopathy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00549029
Recruitment Status : Unknown
Verified October 2007 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 25, 2007
Last Update Posted : October 25, 2007
Information provided by:
National Taiwan University Hospital

October 24, 2007
October 25, 2007
October 25, 2007
August 2007
Not Provided
genotype of specific genes [ Time Frame: one day ]
Same as current
No Changes Posted
single nucleotide polymorphism [ Time Frame: one day ]
Same as current
Not Provided
Not Provided
The Association of Genetic Polymorphisms With Statin-Induced Myopathy.
Association Analysis Between Single Nucleotide Polymorphisms in Statin-Related Genes and The Incidence of Myopathy Among Statin-Treated Patients
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.

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.

Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
whole blood
Probability Sample
National Taiwan University Hospital
  • Rhabdomyolysis
  • Myopathy
Genetic: DNA
withdraw 5~10mL blood from vein only once during the whole design
Group 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy
Intervention: Genetic: DNA
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
January 2008
Not Provided

Inclusion Criteria:

  • Clinical diagnosis of Rhabdomyolysis because of prescription with statins

Exclusion Criteria:

  • Carnitine palmityl transferase ll deficiency
  • McArdle disease
  • Myoadenylate deaminase deficiency
Sexes Eligible for Study: All
21 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
National Taiwan University Hospital
Not Provided
Study Director: Yen-Hui Chen, PhD National Taiwan Univesity College of Medicine
National Taiwan University Hospital
October 2007