[Comparative double-blind investigation of bezafibrate and clofibrate in patients with primary hyperlipoproteinaemia]

The lipid-reducing effects of bezafibrate and clofibrate were investigated in a double-blind crossover trial. 3 x 200 mg/d bezafibrate and 3 x 500 mg/d clofibrate were administered for periods of 8 weeks each to 22 patients with primary hyperlipoproteinaemia (9 Type IIb, 13 Type IV). Placebo periods preceded and followed the periods of medication. Compliance was checked by determination of the serum concentrations of bezafibrate and clofibrate. As compared with the pre-therapy value under placebo, cholesterol was reduced by 14% with bezafibrate and 7% with clofibrate in the group as a whole. In Type IIb patients cholesterol was reduced by 16% with bezafibrate as against 10% with clofibrate, and in Type IV patients by 12% with bezafibrate and 6% with clofibrate. A similar response was found in triglyceride reduction: 36% vs. 18% for the group as a whole; 47% vs. 31% for Type IIb; and 29% vs. 9% for Type IV. The difference in triglyceride reduction for the group as a whole was significant at the p less than 0.05 level. Body weight, pulse rate, and blood pressure showed no changes during the entire period of investigation. Fasting blood glucose was somewhat lower under both substances than under the subsequent placebo period while urea-N and creatinine was increased for both as compared with both pre- and post-therapy placebo periods. Under bezafibrate there was an increase in CPK as compared with the second placebo phase. There were no changes in GOT and GPT. Reductions in gamma-GT, alkaline phosphatase, and bilirubin were observed under both bezafibrate and clofibrate, as were slight decreases in haemoglobin, erythrocytes, and leucocytes, and a small increase in thrombocytes. No changes in urinary excretion of protein or glucose were observed. No subjective side effects were reported, either for bezafibrate or for clofibrate.