The objective was to investigate the tolerance of ethophylline clofibrate (EPC) and its effectiveness on changes of dyslipidaemia and compensation of diabetes in type II diabetics during six-month administration of the preparation Duolip forte (Merckle). Twenty diabetics with dyslipoproteinaemia IIb and IV according to Frederickson's classification, compensated by diet alone or combined with oral antidiabetics (Glucobene, Merckle) were included in the study consecutively according to uniform basal criteria. The selected hypolipidaemic agent was administered to patients according to the following pattern: the first four weeks 1,000 mg (2 tablets in the evening) the next two weeks 1.5 tablets and then till the end of the investigation 1 tablet in the evening. In all patients treatment with EPC led to a significant reduction of the total cholesterol level (CH) at all time intervals. Changes of ApoB, ApoA1 and Lp(a) serum levels did not attain statistical significance but trends were revealed (e.g. a drop of the ApoB/ApoA1 index) which are consistent with the expected favourable action of EPC on the CH distribution in lipoproteins. The triacylglycerol (TG) serum concentration declined significantly already after one month of treatment and after identification of five patients whose TG were distributed in separate clusters the hypotriacylglycerolaemic effect of EPC persisted still three months after treatment. It may be summarized that treatment of dyslipoproteinaemia of the type II diabetics with ethophylline clofibrate (Duolip forte, Merckle) led a) to a marked reduction (13-15%) of serum cholesterol, which b) diminished (to 8-9%) but persisted still after 6 months of treatment, c) the greatest effect of EPC on the TG serum level was observed one month after treatment, d) all improvements of lipid parameters occurred without affecting the compensation of diabetes, or BMI and were not associated with any side-effects of EPC.

Keywords: Clofibrate /analogs & derivatives/; Diabetes Mellitus, Type 2 /complications/; Female; Humans; Hyperlipoproteinemia Type II /complications/; Hyperlipoproteinemia Type IV /complications/; Hypolipidemic Agents /therapeutic use/; Male; Middle Aged