The Association of Genetic Polymorphisms With Statin-Induced Myopathy. - Full Text View

Purpose

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.

Condition	Intervention
Rhabdomyolysis Myopathy	Genetic: DNA

MedlinePlus related topics:

Muscle Disorders

ChemIDplus related topics:

Creatine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Retrospective

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

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

genotype of specific genes [ Time Frame: one day ]

Secondary Outcome Measures:

single nucleotide polymorphism [ Time Frame: one day ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

whole blood

Estimated Enrollment:	150
Study Start Date:	August 2007
Estimated Study Completion Date:	January 2008

Groups/Cohorts	Assigned Interventions
1,2 Group 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy	Genetic: DNA withdraw 5~10mL blood from vein only once during the whole design

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.

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

National Taiwan University Hospital

Criteria

Inclusion Criteria:

Clinical diagnosis of Rhabdomyolysis because of prescription with statins

Exclusion Criteria:

Carnitine palmityl transferase ll deficiency
McArdle disease
Myoadenylate deaminase deficiency

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549029

Contacts


Contact: Yen-Hui Chen, PhD	886-2-2312-3456 ext 8397	tcyhchen@ntu.edu.tw

Contact: Tzung-Dau Wang, PhD	886-2-2312-3456 ext 5632	tdwang@ntu.edu.tw

Locations


Taiwan
	National Taiwan University Hospital	Recruiting
	Taipei, Taiwan, 100
	Contact: Yen-Hui Chen, PhD 886-2-2312-3456 ext 8397 tcyhchen@ntu.edu.tw
	Contact: Tzung-Dau Wang, PhD 886-2-2312-3456 ext 5632 tdwang@ntu.edu.tw
	Principal Investigator: Yen-Hui Chen, PhD

Sponsors and Collaborators

National Taiwan University Hospital

Investigators


Study Director:	Yen-Hui Chen, PhD	National Taiwan Univesity College of Medicine

More Information

Study ID Numbers:	200708077R
First Received:	October 24, 2007
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00549029
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

muscle disorder

statins

creatine kinase

Study placed in the following topic categories:

Rhabdomyolysis

Muscular Diseases

Neuromuscular Diseases

Musculoskeletal Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00549029