[Reductions in lipid fraction plasma levels induced by simvastatin and bezafibrate. Brazilian multicenter study].

PURPOSE

To compare the effects of simvastatin and bezafibrate on the lipid profile to attain the objectives proposed by National Cholesterol Education Program (NCEP).

METHODS

One hundred twenty six hypercholesterolemic patients (69 females and 57 men, 56.0 +/- 10.0 years old), after selection and placebo period (4 weeks) were maintained on lipid-lowering diet and were randomly assigned in a double-blind fashion to receive for 12 weeks, bezafibrate (B, 200mg t.i.d. - BG(n = 66)) or simvastatin (S, 10-40mg q.p.m. - SG(n = 60)). During the study, 28 patients (SG0) received S 10mg; in 14 patients (SG1) dosage was titrated to 20mg and in 18 cases (SG2) to 40mg. Clinical examination, lipid profile and safety determinations, and adverse effects were assessed in different periods of the study.

RESULTS

Mean profile analysis showed different behaviour of BG, SG0, SG1 and SG2 through time for TC, TG, LDL-C and VLDL-C. Mean reductions of TC and LDL-C were more marked in SG (30.3 and 40.9%) than in BG (18.8 and 24.8%). BG showed greater increase of TG (33.7%) and HDL-C (25.9%) than did SG (16.3 and 7.7% respectively). Reduction greater than 30% (optimal responses) and between 20 and 29% (good responses) were more frequent in SG and LDL-C. BG showed greater frequency of good and optimal responses for TG reduction and HDL-C increase. NCEP goals were achieved in 75.4% of SG and 46.9% of BG (p = 0.001). No clinical or laboratorial adverse experiences were reported in any treatment groups.

CONCLUSION

Simvastatin was more effective in the reduction of plasma levels of atherogenic lipid fractions (TC and LDL-C) and this treatment allowed earlier achievement of the goals proposed by NCEP in a greater number of patients.