Volume 9, Number 6, June 2002

Efficacy of micronised fenofibrate in patients with primary hyperlipidaemia: a comparison with pravastatin
Jean Ducobu, Luc Van Haelst, Herva Salomon

This randomised, double-blind, six-month trial assessed the efficacy and tolerability of micronised fenofibrate and pravastatin in 265 patients (18–75 years of age) with primary hyperlipidaemia (pure hypercholesterolaemia, type IIa; and mixed dyslipidaemia, type IIb) recruited from 28 European centres. After a first three-month phase in which patients received once daily either micronised fenofibrate 200 mg or pravastatin 20 mg, type IIa patients attaining low density lipoprotein cholesterol (LDL) < 4.14 mmol/L and type IIb patients attaining LDL < 4.14 mmol/L and triglycerides < 2.26 mmol/L continued with the same dose in a three-month extension phase. Patients not meeting these criteria received a double dose of drug in this extension phase. Micronised fenofibrate and pravastatin were similarly effective in reducing levels of LDL and total cholesterol in patients with pure hypercholesterolaemia and mixed dyslipidaemia in the initial three-month phase, although high density lipoprotein cholesterol (HDL) levels were increased, and triglycerides were reduced, by a significantly greater degree by micronised fenofibrate (p=0.0001 and p=0.0011, respectively).
In the extension phase, in the constant-dosage groups, both treatments maintained their effect in reducing LDL, while micronised fenofibrate maintained the triglyceride reduction more effectively than pravastatin. In the increased dosage group, continued LDL reductions were attained with both treatments, while the patients receiving micronised fenofibrate showed a significantly greater triglyceride reduction than the pravastatin patients.
Treating patients with a new generation fibrate for primary hyperlipidaemia produces LDL and cholesterol-lowering benefits comparable to statin therapy, and has the added advantages of significant triglyceride reduction and a possibly more effective HDL-raising ability.

Br J Cardiol 2002;9:343-350.

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