A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PROSPECTIVE STUDY COMPARING THE SAFE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Subjects are asked to participate in this study because they have been diagnosed with mixed dyslipidemia (characterized by elevated triglycerides and low HDL-C, and moderately elevated LDL-C levels). The study involves an experimental (investigational) drug treatment with fenofibric acid choline salt (fenofibric acid) and atorvastatin calcium to treat abnormal cholesterol levels in the blood. Fenofibric acid is an experimental drug that has not been approved by the US Food and Drug Administration (FDA) and / or by regulatory authorities in other countries outside the United States. It is a derivative of a FDA approved lipid-lowering agent, fenofibrate (TriCor [TM]). Numerous clinical studies have demonstrated that fenofibrate produces reductions in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) "bad cholesterol," and total triglycerides. In addition, treatment with fenofibrate results in increases in high-density lipoprotein cholesterol (HDL-C) "good cholesterol." Clinical studies and epidemiological investigations have established that cardiovascular morbidity and mortality vary directly with the levels of TC, LDL-C and triglycerides, and inversely with the level of HDL-C. The prevalence of mixed dyslipidemia has been increasingly associated with the presence of other coronary heart disease risk factors such as abdominal obesity and hypertension. Since fenofibrate is rapidly converted to fenofibric acid during or immediately following absorption and fenofibric acid, not fenofibrate, is found in circulating plasma, it is actually the effects of fenofibric acid that have been extensively evaluated. Due to the potential of fenofibric acid to provide improved absorption, distribution, metabolism, and elimination in patients, along with it's proven efficacy and safety demonstrated through administration of fenofibrate, a formulation of fenofibric acid is being developed as a lipid-lowering agent. Atorvastatin calcium (Lipitor [TM]) is a cholesterol-lowering medication, known as a statin, that is already approved by the FDA. The primary purpose of this study is to compare the side effects and activity (whether the drugs correct the level of cholesterol in your blood system) between fenofibric acid when taken alone or in combination with atorvastatin calcium, and at different doses of the statin. The use of combination therapy has become more prevalent in clinical practice as physicians seek to achieve desirable levels of blood lipids while minimizing exposure to higher doses of each component in a drug combination. In some patients, therapy with a single lipid lowering agent will be insufficient to achieve National Cholesterol Education Program (NCEP) established lipid targets. There is currently no single therapeutic agent that can simultaneously normalize elevated levels of LDL=C and TG and raise low levels of HDL-C to desired levels.