Clinical trial NCT01414803: Tolerability and Efficacy of Rosuvastatin - Fenofibrate Combine Therapy in Korean Patients With Combined Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperlipidemia
Keywords: rosuvastatin, fenofibrate, creatine kinase, alanine aminotransferase
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of elevation of CK>5x ULN or AST>3x ULN or ALT>3x ULN
timeFrame: 24 weeks after drug treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Paterson JM, Smith SM, Simpson J, Grace OC, Sosunov AA, Bell JE, Antoni FA. Characterisation of human adenylyl cyclase IX reveals inhibition by Ca(2+)/Calcineurin and differential mRNA plyadenylation. J Neurochem. 2000 Oct;75(4):1358-67. doi: 10.1046/j.1471-4159.2000.0751358.x.
citation: Lee SH, Cho KI, Kim JY, Ahn YK, Rha SW, Kim YJ, Choi YS, Choi SW, Jeon DW, Min PK, Choi DJ, Baek SH, Kim KS, Byun YS, Jang Y. Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia. Atherosclerosis. 2012 Mar;221(1):169-75. doi: 10.1016/j.atherosclerosis.2011.12.042. Epub 2012 Jan 5.