Tolerability and Efficacy of Rosuvastatin - Fenofibrate Combine Therapy in Korean Patients With Combined Hyperlipidemia

Study Overview
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Brief Summary
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Although the combination of statin and fenofibrate is one of the options for patients with combined hyperlipidemia, non-lipid effects of it has not been completely understood yet. In this study we compared the effects of rosuvastatin 10 mg/fenofibrate 160 mg combination and rosuvastatin 10 mg monotherapy on muscle and liver enzyme, homocysteine levels, kidney, blood glucose control, and blood cell counts.

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Drug: Lipid modification
* Drug: Lipid modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mixed hyperlipidemia: total cholesterol levels higher than 220 mg/dL, triglyceride (TG) levels between 200 and 500 mg/dL, and low-density lipoprotein (LDL)-cholesterol levels higher than 130 mg/dL after 6-week diet/life style change Men and women who were between 20 and 70 years of age Having at least one history of: coronary artery disease, cerebrovascular disease or transient ischemic attack, peripheral vascular disease, or diabetes mellitus. Having risk factors at least two of: age ≥45 years in male or ≥55 years in female, elevated blood pressure (systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or treatment of previously diagnosed hypertension), high-density lipoprotein (HDL)-cholesterol <40 mg/dL, family history of coronary artery disease at age <55 years in male or <65 years in female, central obesity (waist circumference ≥90 cm for male or ≥80 cm for female), fasting plasma glucose ≥110 mg/dL, or left ventricular hypertrophy on electrocardiogram Written informed consent. Exclusion Criteria: pregnant or breast-feeding uncontrolled hypertension uncontrolled diabetes mellitus thyroid dysfunction serum transaminase level >2 times the upper limit of normal history of gall bladder disease chronic alcoholic serum creatinine level >1.5 mg/dL history of myopathy history of acute myocardial infarction or acute stroke within 3 months before the study began acute or chronic infection or inflammation history of cancer history of adverse events associated with test drugs.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rosuvastatin/fenofibrate combination<br>rosuvastatin 10 mg/fenofibrate 160 mg per day | Drug: Lipid modification<br>* rosuvastatin 10 mg/fenofibrate 160 mg per day<br>|
| Active Comparator: rosuvastatin monotherapy<br>rosuvastatin 10 mg per day | Drug: Lipid modification<br>* rosuvastatin 10 mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of elevation of CK>5x ULN or AST>3x ULN or ALT>3x ULN |  | 24 weeks after drug treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosuvastatin, fenofibrate, creatine kinase, alanine aminotransferase