Hyperlipidemia
Conditions
Keywords
rosuvastatin, fenofibrate, creatine kinase, alanine aminotransferase
Brief summary
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.
Interventions
rosuvastatin 10 mg/fenofibrate 160 mg per day
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of elevation of CK>5x ULN or AST>3x ULN or ALT>3x ULN | 24 weeks after drug treatment |
Countries
South Korea
Outcome results
None listed