[Multicenter study of the efficacy and tolerance of gemfibrozil and fenofibrate in the treatment of primary hyperlipoproteinemia]. / Multicentricna studija efikasnosti i podnosljivosti gemfibrozila i fenofibrata u lecenju primarne hiperlipoproteinemije.

ABSTRACT

In the primary prevention of atherosclerosis and risk of lipoproteinemia, is of primordial importance. Therefore, adequate food and physical activities are necessary. If no good result is evident thereafter medicinal treatment should be prescribed. In our open random study performed in two different centres, we evaluated the efficiency and tolerance of Gemfibrozile and Phenofibrate in 77 patients with IIa, IIb, and IV stage of hyperlipoproteinaemia. The study included the patients in whom the 8-week diet gave no expected results. The evaluation of Gemfibrosile (900 mg daily) and Phenofibrate (300 m daily) efficiency lasted 12 weeks. During that time 11 patients were excluded from the study because of administration of other relevant drugs or for lack of control examinations. The efficiency was evaluated in 66 patients 33 to Gemfibrozile and 31 to Phenofibrate. At the end of treatment the following results were obtained decreased cholesterol level by 17% in Gemfibrozile patients and by 6% in Phenofibrate subjects; LDL-cholesterol by 15% i.e. 3% and triglycerides by 48% in Gemfibrozile cases and by 27% in Phenofibrate individuals. At the end of treatment HDL-cholesterol was increased by 29% in patients treated with Gemfibrozile and by 9% in those treated with Phenofibrate. Apoprotein A-1 was increased after Phenofibrate treatment and decreased after Gemfibrozile administration. Apoprotein B was increased in both groups. No harmful clinical or laboratory effects were observed. On the basis of these results it can be concluded that the effect of Gemfibrozile was more favourable on lipod composition in the plasma then that of Phenofibrate. No significant differences in drug tolerance were observed.