Retrospective comparison of the effectiveness of a fenofibrate 145 mg formulation compared with the standard 160 mg tablet

Abstract

Objective: To compare changes in lipid levels (total cholesterol [total-C], low-density lipoprotein cholesterol [LDL-C], triglycerides [TG], and high-density lipoprotein cholesterol [HDL-C]) for patients who switched from standard fenofibrate 160 mg (requiring dosing with food) to fenofibrate 145 mg with no food effect (NFE).

Methods: The analyses were performed using an electronic medical records dataset from 1 January 2003 to 31 July 2005. Patients were eligible for the analysis if they had a diagnosis of hypertension, dyslipidaemia or diabetes mellitus, were written a prescription for standard fenofibrate 160 mg during the period 1 May 2004 to 30 April 2005, and were written a subsequent prescription for fenofibrate 145 mg NFE at least 60 days after first receiving the 160 mg dose. The outcomes measured were lipid levels: total-C, LDL-C, HDL-C and TG.

Results: 491 patients who switched from standard fenofibrate 160 mg to fenofibrate 145 mg NFE met all of the inclusion criteria. Patients who changed therapy to fenofibrate 145 mg NFE from standard fenofibrate 160 mg showed a beneficial response in lipid levels. Statistically significant patient-specific changes in lipid levels were observed for the change from baseline to standard fenofibrate 160 mg for three lipid levels (total-C, HDL-C and TG). Statistically significant changes were observed for the switch to fenofibrate 145 mg NFE for three lipid levels (total-C, LDL-C and TG).

Conclusions: More patients treated in an outpatient clinical practice had better lipid results when prescribed fenofibrate 145 mg NFE than those prescribed standard fenofibrate 160 mg, suggesting that a less restrictive dosing regimen improves lipid outcomes.