Effectiveness of a fenofibrate 145-mg nanoparticle tablet formulation compared with the standard 160-mg tablet in patients with coronary heart disease and dyslipidemia

Abstract

Study objective: To compare the effectiveness of a fenofibrate 145-mg nanoparticle tablet formulation with the standard 160-mg tablet in patients with dyslipidemia and coronary heart disease.

Design: Retrospective medical record review.

Setting: Outpatient university-affiliated cardiology clinic.

Patients: One hundred thirty patients with dyslipidemia and coronary heart disease treated for a minimum of 6 months with fenofibrate 160 mg/day (with or without 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor [statin] therapy) who were then switched to a minimum of 3 months of treatment with fenofibrate 145 mg/day.

Measurements and main results: Low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), and triglyceride levels were compared during treatment with each formulation. In patients not taking statins, statistically significant reductions of 4.6% and 2.3%, respectively, were noted in mean triglyceride and LDL levels after the switch to fenofibrate 145 mg/day. In patients taking statins, statistically significant reductions of 5.1% and 2.8%, respectively, were observed in mean triglyceride and LDL levels. In total, a larger proportion of patients had 10% or greater improvement in LDL (14/130 [11%]) and triglyceride (32/130 [25%]) levels compared with the proportion of patients who had 10% or greater worsening in LDL (3/130 [2%]) and triglyceride (9/130 [7%]) levels, and a net additional 14 patients (11%) achieved National Cholesterol Education Program (NCEP) lipid panel targets after the switch to fenofibrate 145 mg/day. Mean HDL level was not significantly different after the switch to fenofibrate 145 mg/day. Safety parameters of fenofibrate 145-mg/day therapy were not examined, although fenofibrate 160 mg/day is generally well tolerated.

Conclusion: Eleven percent of the patients in our study had improvements in their lipid profiles that resulted in achievement of NCEP lipid panel targets after treatment with the 145-mg nanoparticle formulation of fenofibrate. This improvement in lipid levels may have been related to increased bioavailability of the 145-mg formulation. However, the exact mechanism of the improvement in lipid levels is unknown.