[The comparative treatment with lovastatin and bezafibrate of primary hypercholesterolemia. A randomized and double-blind trial]

Abstract

The efficacy and tolerability of lovostatin (L) and bezafibrate (B) were compared in a total of 39 patients, 24 males and 15 females, 59 +/- 9 years old. Showing a total serum cholesterol superior to 250 mg/dl and total serum triglycerides inferior to 350 mg/dl, after 1 month on a low cholesterol diet and another on placebo, were eligible for participation. After randomization 19 treated with L started with 20 or 40 mg at night according to baseline cholesterol under or above 300 respectively and 20 with B received 200 mg tid. If after 6 weeks of therapy cholesterol remained above 200, the doses of L or matching placebo in those with B was double while dose of B or matching placebo remained constant. Cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol were determined using an enzymatic analytical method. Apolipoproteins were obtained by radial immunodiffusion. Routine hematological analysis and blood chemistry safety tests were performed at baseline and every 6 weeks during active treatment. The average most important results, after 12 weeks of treatment, comparing L vs B were: 1) cholesterol was reduced 26 vs 10% (p less than 0.001); 2) LDL-cholesterol decreased 35 vs 15% (p less than 0.001); 3) HDL-cholesterol increased 5 vs 19% (p = NS); 4) triglycerides diminished 15 vs 18% (p = NS). Three patients in L and 1 in B showed adverse events and two of them, one each group, were drop-out. In summary: a) L was more effective lowering total cholesterol and LDL-cholesterol; b) B was more potent decreasing triglycerides and increasing HDL-cholesterol; c) both drugs showed good tolerability.