The Association of Genetic Polymorphisms With Statin-Induced Myopathy.
NCT ID: NCT00549029
Last Updated: 2007-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2007-08-31
2008-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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1,2
Group 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy
DNA
withdraw 5\~10mL blood from vein only once during the whole design
Interventions
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DNA
withdraw 5\~10mL blood from vein only once during the whole design
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* McArdle disease
* Myoadenylate deaminase deficiency
21 Years
80 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Principal Investigators
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Yen-Hui Chen, PhD
Role: STUDY_DIRECTOR
National Taiwan Univesity College of Medicine
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Yen-Hui Chen, PhD
Role: primary
Tzung-Dau Wang, PhD
Role: backup
References
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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.
Other Identifiers
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200708077R
Identifier Type: -
Identifier Source: org_study_id