MULTICENTER COMPARISON OF MICRONIZED FENOFIBRATE AND SIMVASTATIN IN PATIENTS WITH PRIMARY TYPE IIA OR IIB HYPERLIPOPROTEINEMIA

In 12 weeks of active treatment, we compared the efficacy and safety o f a new (micronized) formulation of fenofibrate (F) (200 mg/day) with that of simvastatin (S) (20 mg/day), an inhibitor of hydroxy-methyl-gl utaryl coenzyme A (HMG-CoA)-reductase. Men and women with primary hype rlipoproteinemia (HLP) with low-density lipoprotein (LDL) cholesterol level 180-300 mg/dl and triglyceride level <500 mg/dl had dietary trea tment for 8 weeks, and 133 (2 of 3 type IIa, 1 of 3 type IIb HLP) were randomized. The decrease in total cholesterol differed between type I Ia patients (F - 17.9 vs. S - 25.8%), the decrease in triglyceride lev els between the type II b groups (F - 52.8 vs. S - 14%), whereas the d egree of decrease in LDL cholesterol (F - 20.9 vs. S - 34.9%) differed among all patients. Despite the difference in LDL cholesterol decreas e, no difference was noted in total apolipoprotein (apo) B lowering (F - 20.8 and S - 26.5%). Increases in high-density lipoprotein (HDL) ch olesterol (F + 18.5 vs. S + 15%) differed specifically in type IIb pat ients (F + 33.6 vs. S + 11.4%), accompanied by a more pronounced incre ase in apo AI with fenofibrate (F + 10.5% vs. S no change). Improvemen t in the ratios of total cholesterol/HDL cholesterol and apo AI/apo B occurred similarly with both drugs. Only fenofibrate, not simvastatin, decreased both fibrinogen (-10.3 vs. + 3.6%) and uric acid (- 25% vs. no change) in type IIa and type IIb patients. Safety parameters refle cted drug-specific known side effects, underscoring the safety of both drugs in addition to their efficacy in lipid lowering. Besides its ad vantages in type IIb hyperlipidemia, micronized fenofibrate proved a p otent drug in decreasing total and LDL cholesterol and in very effecti vely decreasing apo B-containing lipoproteins, which is a recommendati on for its use in primary hypercholesterolemia.