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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Hyperlipidemia

Treatments: Drug: Lipid modification

Study type: Interventional

Funder types: Other

Identifiers

NCT01414803

4-2008-0390

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

rosuvastatin/fenofibrate combination

Experimental group

Description:

rosuvastatin 10 mg/fenofibrate 160 mg per day

Treatment:

Drug: Lipid modification

Drug: Lipid modification

rosuvastatin monotherapy

Active Comparator group

Description:

rosuvastatin 10 mg per day

Treatment:

Drug: Lipid modification

Drug: Lipid modification