Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
516
Combination of fenofibrate and simvastatin 20 mg and 40 mg
Atorvastatin 10 mg and 20mg
Percent change from baseline to 12 weeks of treatment in Triglycerides
Time frame: 12 weeks
Percent change from baseline to 12 weeks of treatment in HDL-C
Time frame: 12 weeks
Percent change from baseline to 12 weeks of treatment in LDL-C
Time frame: 12 weeks
Percent change from baseline to 12 weeks of treatment in Triglycerides
Time frame: 24 weeks
Percent change from baseline to 12 weeks of treatment in HDL-C
Time frame: 24 weeks
Percent change from baseline to 12 weeks of treatment in LDL-C
Time frame: 24 weeks
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