Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy

Single Nucleotide Polymorphism Clinical Trial

Official title:

Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00509574
• Other study ID #: 200702006M
• Status: Recruiting
• Phase: Phase 4
• First received: July 29, 2007
• Last updated: December 10, 2010
• Start date: March 2007
• Est. completion date: February 2010

Study information

• Verified date: November 2010
• Source: National Taiwan University Hospital
• Contact: Tzung-Dau Wang, MD, PhD
• Phone: 886-2-2312-3456
• Email: tdwang[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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.

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Single Nucleotide Polymorphism
• Statins, HMG-CoA

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,