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Fenofibrate and fenofibric acid are used as adjuncts to dietary therapy in the management of primary hypercholesterolemia and mixed dyslipidemia. The drugs also are used as adjuncts to dietary therapy in the management of severe hypertriglyceridemia. Drug therapy is not a substitute for, but an adjunct to, these nondrug therapies and measures, which should be continued when drug therapy is initiated. The effects of fenofibrate and fenofibric acid on cardiovascular morbidity and mortality or noncardiovascular mortality have not been established. Fenofibrate and fenofibric acid are used as adjuncts to dietary therapy to decrease elevated serum total and low-density lipoprotein LDL -cholesterol, triglyceride, and apolipoprotein B apo B concentrations, and to increase high-density-lipoprotein HDL -cholesterol concentrations in the management of primary hypercholesterolemia and mixed dyslipidemia, including heterozygous familial hypercholesterolemia and other causes of hypercholesterolemia. Efficacy and safety of fenofibrate and fenofibric acid in the management of hypercholesterolemia were established in 4 randomized, double-blind, placebo-controlled studies of months' duration in patients with primary hypercholesterolemia or mixed dyslipidemia.
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