Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy
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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.
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy |
blood samples are obtained for genomic DNA extraction.
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | February 2010 |
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 |
Hyperlipidemic patients meeting the criteria of NCEP ATPIII for drug treatment at internal medicine clinic of National Taiwan University Hospital.
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| Contact: Tzung-Dau Wang, MD, PhD | 886-2-2312-3456 ext 5632 | tdwang@ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan | |
| Principal Investigator: | Tzung-Dau Wang, MD, PhD | Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | Tzung-Dau Wang, MD, PhD, National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00509574 History of Changes |
| Other Study ID Numbers: | 200702006M |
| Study First Received: | July 29, 2007 |
| Last Updated: | December 10, 2010 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Single Nucleotide Polymorphism statins hyperlipidemia |
ClinicalTrials.gov processed this record on May 19, 2013