A randomized placebo-controlled double-blind trial of lipid lowering strategies in patients with renal insufficiency: diet modification with or without fenofibrate

Background: Renal insufficiency is characterized by lipoprotein abnormaliti es including elevated triglyceride levels. Patients and methods: The safety and efficacy of micronized fenofibrate as a treatment for dyslipidemia in patients with progressive renal insufficiency was evaluated in a randomized , placebo-controlled double-blind study comparing fenofibrate and dietary m odification to dietary modification alone. Patients were evaluated followin g a 3-month pre-randomization period of dietary counseling Twenty-eight pat ients with moderate renal insufficiency and triglyceride levels 2.3 mmol/l or LDL/HDL ratio 5 were randomized to placebo (n = 12) or fenofibrate (n = 16) therapy. Treatment and dietary counseling continued for 6 months. Resul ts: Ten of 16 patients (63%) treated with fenofibrate achieved a 30% reduct ion in triglyceride levels or LDL/HDL ratio reduction < 5 compared to 2 of 17% in the placebo group (p = 0.015). Triglyceride levers were significantl y reduced in the fenofibrate group (-31%) versus placebo (+1.3%, p = 0.003) . In compliant patients (n = 25) there was also a significantly greater inc rease in HDL cholesterol levels in the fenofibrate group (+19.9%) compared to placebo (-4.7%, p = 0.001). Changes in measured creatinine clearance wer e not significantly different between the groups and there were no serious adverse effects of treatment. Conclusion. Fenofibrate therapy combined with dietary modification effectively reduced triglyceride levels in renal insu fficiency patients without serious adverse effects.