Low incidence of paradoxical reductions in HDL-C levels in dyslipidemic patients treated with fenofibrate alone or in combination with ezetimibe or ezetimibe/simvastatin

Michel Farnier, Qian Dong, Arvind Shah, Amy O Johnson-Levonas, Philippe Brudi, Michel Farnier, Qian Dong, Arvind Shah, Amy O Johnson-Levonas, Philippe Brudi

Abstract

Background: Fibrates have been reported to cause paradoxical decreases in HDL-C in certain patients.

Design and methods: This post-hoc analysis explored the frequency/magnitude of HDL-C reductions in a pooled database of mixed dyslipidemic patients (LDL-C:3.4-5.7 mmol/L;TG:1.7-5.7 mmol/L) receiving placebo (PBO), fenofibrate (FENO), ezetimibe plus FENO (EZE+FENO), or EZE/simvastatin plus FENO (EZE/SIMVA+FENO) for 12 weeks.

Results: PBO-treated patients had the highest incidence of HDL-C reductions from baseline (45%) compared with patients taking FENO (14%), EZE+FENO (9%), or EZE/SIMVA+FENO (9%). Reductions <30% reflected natural variability since the largest reduction in HDL-C approached 30% in the PBO group. Only 3 patients exhibited HDL-C reductions ≥30% (i.e., 2 patients in the FENO group and 1 in the EZE+FENO group). There were no differences in demographic/biochemical characteristics between patients with and without HDL-C reductions.

Conclusions: The incidence of paradoxical HDL-C reductions was low in mixed dyslipidemic patients receiving FENO alone or combined with EZE or EZE/SIMVA.

Trial registration: ClinicalTrials.gov NCT00092560 NCT00092573.

Figures

Figure 1
Figure 1
Distribution in mean percent. Distribution in mean percent changes from baseline in HDL-C for patients in the placebo group (n = 123) (A); fenofibrate 160 mg group (n = 368) (B); ezetimibe 10 mg plus fenofibrate 160 mg group (n = 183) (C); and ezetimibe/simvastatin 10/20 mg plus fenofibrate 160 mg group (n = 180) (D)
Figure 2
Figure 2
Distribution of HDL-C values. Distribution of HDL-C values (mmol/L) at baseline and study endpoint for patients in the placebo group (n = 123) (A); fenofibrate 160 mg group (n = 368) (B); ezetimibe 10 mg plus fenofibrate 160 mg group (n = 183) (C); and ezetimibe/simvastatin 10/20 mg plus fenofibrate 160 mg group (n = 180) (D)

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