Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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Treatment using statin has been decreased the risk of cardiovascular events in pre-dialysis CKD population. Supplementation with omega-3 fatty acid (FA) lowers the risk of cardiovascular death in patients with myocardial infarction. This cardioprotective effect of omega-3 FA can be explained by anti-inflammatory, anti-oxidative, or anti-thrombotic effects. Statin such as pravastatin is also known to have anti-inflammatory and antioxidant properties, suggesting that statin may replace the cardioprotective effect of omega-3 fatty acids. Erythrocyte membrane oleic acid is significantly higher in patients with acute coronary syndrome than control subjects. The cardioprotective effect of omega-3 FA may also be related to decreased oleic acid content of erythrocyte membrane. There is no report about the effect of statin on FA including erythrocyte membrane oleic acid. As omega-3 FAs are recognized as therapeutic agents for reducing triglycerides, statin may affect on the erythrocyte membrane FA. Therefore, pravastatin supplementation can modify erythrocyte membrane FA contents including oleic acid in CKD patients.

Detailed Description
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Patients with chronic kidney disease (CKD) have higher risk of death and cardiovascular disease than general population. Treatment using statin has been decreased the risk of cardiovascular events in pre-dialysis CKD population. Supplementation with omega-3 fatty acid (FA) lowers the risk of cardiovascular death in patients with myocardial infarction. This cardioprotective effect of omega-3 FA can be explained by anti-inflammatory, anti-oxidative, or anti-thrombotic effects. Statin such as pravastatin is also known to have anti-inflammatory and antioxidant properties, suggesting that statin may replace the cardioprotective effect of omega-3 fatty acids. Omega-3 FA such as EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid), and EPA/arachidonic acid ratio are well known as key indicators of cardiovascular disease. In addition, erythrocyte membrane oleic acid is significantly higher in patients with acute coronary syndrome than control subjects. The cardioprotective effect of omega-3 FA may also be related to decreased oleic acid content of erythrocyte membrane. There is no report about the effect of statin on FA including erythrocyte membrane oleic acid. As omega-3 FAs are recognized as therapeutic agents for reducing triglycerides, statin may affect on the erythrocyte membrane FA. Therefore, pravastatin supplementation can modify erythrocyte membrane FA contents including oleic acid in CKD patients.

Official Title
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Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: Pravastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CKD patients who agreed with written informed consent CKD patients who do not take statin Who have LDL cholesterol over 100mg/dL and coronary vascular disease(CVD) or equivalent risk; Who have LDL cholesterol over 130mg/dL and two or more coronary vascular risk; Whose LDL cholesterol over 160mg/dL in patient with CKD stage 1 to 5 without dialysis. Exclusion Criteria: Patients with acute illness, a history of active infection, CVD, acute kidney injury during the past 3 months, or a history of malignancy or liver disease Patients using statin, omega-3 fatty acid or sevelamer hydrochloride within 3 months Patients who experienced side effects by statin treatment Pregnant or pregnancy expected CKD patients Patient with dyslipidemia due to nephrotic syndrome Patient taken imaging study using contrast media during the past 14 days Patient with albumin level < 3.0 g/dL

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pravastatin group<br>Use of pravastatin 20mg to 40mg | Drug: Pravastatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change of erythrocyte membrane fatty acid including oleic acid |  | 24 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change of total cholesterol |  | 24 weeks after intervention | 
| mean change of triglyceride |  | 24 weeks after intervention | 
| mean change of LDL-cholesterol |  | 24 weeks after intervention | 
| mean change of HDL-cholesterol |  | 24 weeks after intervention | 
| mean change of adiponectin |  | 24 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, pravastatin, erythrocyte membrane fatty acid