Comparative study of bezafibrate and probucol in hyperlipidaemia.

Sixty out-patients diagnosed as having hyperlipidaemia, with a cholesterol level of greater than 200 mg/dl and/or a triglycerides level of greater than 200 mg/dl, took part in the trial. Patients were divided at random into two groups to receive pharmacological treatment plus diet; one group was given 500 mg probucol twice a day and the other group 200 mg bezafibrate twice or 3-times a day for an average treatment period of 60 days. The percentage changes in serum lipids, i.e. total cholesterol, triglycerides, HDL-cholesterol, and LDL-cholesterol, were evaluated by comparing the values before and at the end of treatment, and tolerability of the drug in use was evaluated from the appearance of adverse reactions and the ECG and blood pressure parameters. Whereas total cholesterol and LDL-cholesterol levels were reduced to a similar extent in both groups (cholesterol - 42% bezafibrate, 38.3% probucol; LDL-cholesterol - 30.8% bezafibrate, 26.5% probucol), triglycerides were reduced to a significantly greater extent (p less than 0.05) in the benzafibrate group (55.5%) than in the probucol group (24.0%). The most significant percentage change (p less than 0.005) was found with HDL-cholesterol; in the bezafibrate group, levels increased by 19.0% compared with a 11.8% reduction in the probucol group. Four (13.3%) patients on bezafibrate and 5 (16.7%) on probucol reported mild to moderately severe side-effects, mainly gastro-intestinal, but in no case was treatment interrupted, although benzafibrate dosage was temporarily reduced. ECG changes (prolongation of QTc) were recorded in 3 patients on probucol and these reverted to normal after the end of the trial.