Clinical trial NCT00509574: Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy
Official title: Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Statins, HMG-CoA
Single Nucleotide Polymorphism
Keywords: Single Nucleotide Polymorphism
statins
hyperlipidemia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2007-07-31
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital
name: Tzung-Dau Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: