Effect of Lipid Modifying Drugs on HDL Function in Patients With Hyperlipidemia

Yonsei University

Status: Completed

Conditions: Hyperlipidemia

Treatments: Drug: Omega-3 2g; Drug: Atorvastatin 20 mg; Behavioral: Lifestyle modification; Drug: Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg; Drug: Cholestyramine 8 g

Study type: Interventional

Funder types: Other

Identifiers

NCT02942602

4-2013-0281

Details and patient eligibility

About

1. to test HDL function comprehensively in healthy and diseased individuals; 2) to evaluate if this test correlates with cardiovascular risk, independent of traditional risk factors; 3) and to differentiate effects of lipid-modifying or antiatherosclerotic drugs on HDL function and composition

Enrollment: 58 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy
• Aged over 20
• Consent form signed

Exclusion criteria

• pregnant or lactating women
• subjects with familial hypercholesterolemia
• uncontrolled hypertension or DM
• Thyroid dysfunction
• Active liver disease (transaminase or bilirubin > 1.5 x NL)
• Serum creatinine > 2 mg/dL
• Included in other clinical trials within 3 months
• using of other medication: fish oil, fibric acid derivatives, niacin, systemic corticosteroid, thiazolidinedione

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 5 patient groups

Atorvastatin 20 mg

Experimental group

Description:

lipid lowering treatment

Treatment:

Drug: Atorvastatin 20 mg

Cholestyramine 8 g

Experimental group

Description:

lipid lowering treatment

Treatment:

Drug: Cholestyramine 8 g

Omega-3 (EPA+DHA) 2 g

Experimental group

Description:

lipid lowering treatment

Treatment:

Drug: Omega-3 2g

Atorvastatin 5 mg + Ezetimibe 10 mg

Experimental group

Description:

lipid lowering treatment

Treatment:

Drug: Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg

Life style modification for management of dyslipidemia

Active Comparator group

Treatment:

Behavioral: Lifestyle modification