Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Tzung-Dau Wang, MD, PhD; Phone Number: 5632 886-2-2312-3456; Email: tdwang@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hyperlipidemic patients meeting the criteria of NCEP ATPIII for drug treatment at internal medicine clinic of National Taiwan University Hospital.

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Tzung-Dau Wang, MD, PhD, Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Study Completion (Anticipated): February 1, 2010

Study Registration Dates

• First Submitted: July 29, 2007
• First Submitted That Met QC Criteria: July 30, 2007
• First Posted (Estimate): July 31, 2007

Study Record Updates

• Last Update Posted (Estimate): December 13, 2010
• Last Update Submitted That Met QC Criteria: December 10, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: statins; hyperlipidemia; Single Nucleotide Polymorphism
• Other Study ID Numbers: 200702006M