Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy - Full Text View

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00509574

Purpose

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.

Condition	Phase
Statins, HMG-CoA Single Nucleotide Polymorphism	Phase IV

MedlinePlus related topics: Statins

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy

Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

blood samples are obtained for genomic DNA extraction.

Estimated Enrollment:	200
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2008

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.

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509574

Contacts

Contact: Tzung-Dau Wang, MD, PhD

886-2-2312-3456 ext 5632

tdwang@ntu.edu.tw

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Tzung-Dau Wang, MD, PhD

Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital

More Information

Responsible Party:	National Taiwan University Hospital ( Tzung-Dau Wang, MD, PhD )
Study ID Numbers:	200702006M
Study First Received:	July 29, 2007
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00509574
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Single Nucleotide Polymorphism
statins
hyperlipidemia

Study placed in the following topic categories:

Hyperlipidemias

ClinicalTrials.gov processed this record on January 16, 2009