Fenofibrate in type IV and type V hyperlipoproteinemia.

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 fenofibrate-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 patients with type IV or V hyperlipoproteinemia, and caused no clinically significant adverse effects that would preclude its use in these patients.