A US multicenter, double-blind, placebo-controlled study was performed to evaluate the efficacy and safety of fenofibrate in patients with type IV or V hyperlipoproteinemia. One hundred forty-seven patients entered the study and all were stabilized on a low-fat diet. Following a placebo baseline period, patients were stratified according to plasma triglyceride (TG) levels (group A, 350–499 mg/dl; group B, 500–1,500 mg/dl) and randomly assigned to treatment with either 100 mg fenofibrate or one placebo capsule three times a day with meals. Demographically, the treatment groups were similar. A dramatic reduction in total TG levels occurred in the fenofïbrate-treated patients but not in the placebo-treated patients. This effect was seen in both group A (46%) and group B (55 %) patients and reached near-maximum reduction in only 2 weeks of treatment. In both groups, fenofibrate treatment also decreased very low-density lipoprotein (VLDL) TG, total cholesterol and VLDL cholesterol, and increased high-density lipoprotein levels. Adverse effects of fenofibrate were minimal compared with placebo and resolved when the drug was discontinued. Overall, fenofibrate was found to be effective in
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