Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy

• Conditions: Statins, HMG-CoA; Single Nucleotide Polymorphism

• Registration Number: NCT00509574
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, also known as statins, played an important role in lipid-lowering therapy and reduction of cardiovascular risks. However, it has been observed that the response to statin therapy varies from patient to patient, and gene polymorphism could have contributed to the variation.

Detailed Description

Hyperlipidemic patients are retrospectively screened from 2006/1/1 to 2006/12/31. The patient is included if he or she had been receiving atorvastatin or rosuvastatin for at least 3 months and did not receive other lipid-lowering medications 4 weeks before starting atorvastatin or rosuvastatin. Genomic DNA was collected from the blood sample of each patient using genomic DNA purification kit. The single nucleotide polymorphisms (SNPs) were determined afterward.

The correlation between response of statin therapy, defined as changes in lipid profiles including triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol, and SNPs examined.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-07-29
• Study First Submitted QC: 2007-07-30
• Study First Posted: 2007-07-31
• Study Completion: 2010-02
• Status Verified: 2010-11
• Last Update Submitted: 2010-12-10
• Last Update Posted: 2010-12-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• aged 21-80.
• conforms with the criteria of National Cholesterol Education Program Adult Treatment Panel III for medication therapy.
• have received atorvastatin or rosuvastatin regularly for 12 weeks or longer.
• available lipid profiles such triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol 12-24 weeks after staring statin therapy.

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Exclusion Criteria

• had been using lipid-lowering medications including statins 4 weeks before starting atorvastatin or rosuvastatin.
• received other lipid-lowering medications, erythromycin, immunosuppressant or azole antifungals concomitantly.
• pregnant, breast-feeding, or able to become pregnant.
• have a history of alcohol or substance abuse.
• liver cirrhosis or ALT exceeds the upper limit of normal range.
• untreated hypothyroidism.
• patients with malignant tumor who have received chemotherapy or radiotherapy.
• known allergy to atorvastatin, rosuvastatin or other statins.
• unwilling to provide written informed consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan