Effects of micronized fenofibrate versus atorvastatin in the treatment of dyslipidaemic patients with low plasma HDL-cholesterol levels:: a 12-week randomized trial

Background. Studies have suggested that raising low levels of high-density lipoprotein cholesterol (HDL-C) may be an important target for the prevention of coronary heart disease. Objective. To compare the ability of micronized fenofibrate and atorvastatin to increase plasma HDL-C levels. Design. Multicentre, randomized open-label study. Settings. The study was conducted in 19 centres across the UK and Canada. Subjects. One hundred and eighty-one patients were randomized and the full analysis set included 165 nondiabetic patients with low HDL-C (women <46 mg dL(-1) , i.e. 1.2 mmol L-1 and men <43 mg dL(-1) , i.e. 1.1 mmol L-1): 86 patients in the atorvastatin group and 79 patients in the micronized fenofibrate group. Interventions. Micronized fenofibrate (200 mg day(-1) , 87 patients) or atorvastatin (10 mg day(-1) , 94 patients) for a period of 12 weeks. Main outcome measures. Percent change in HDL-C levels. Results. After 12 weeks of treatment, the mean percent change from baseline in HDL-C was significantly higher in the micronized fenofibrate group (13.3%) compared with the atorvastatin group (5.3%, P =0.0003). The magnitude of such relative change was inversely related to the baseline HDL-C levels only in the micronized fenofibrate group. Furthermore, in the fenofibrate treatment group, 50.9% of the patients (29 of 57 patients) with a baseline HDL-C <40 mg dL(-1) achieved a plasma HDL-C level above 40 mg dL(-1) after 12 weeks of treatment versus 27.9% of the patients (19 of 68 patients) in the atorvastatin group (P =0.01). Conclusions. On the basis of (1) the greater impact of fenofibrate than atorvastatin on HDL-C levels and (2) the greater proportion of dyslipidemic patients achieving HDL-C levels above 40 mg dL(-1) with fenofibrate than atorvastatin, it is suggested that micronized fenofibrate should be considered as a good therapeutic option to treat dyslipidemic patients with low HDL-C and moderately elevated LDL-C concentrations.