Arzneimittel-Forschung · 1980
[Effect of etofylline clofibrate on the composition of lipoproteins in hyperlipidaemia type IIb and IV (author's transl)].
Клиническое исследованиеКонтролируемое клиническое исследованиеАннотация на английскомСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Ditschuneit H H, Hutt V, Klör H U, Ditschuneit H
Аннотация
Efficacy of 1-(theophyllin-7-yl)-ethyl-2[2-(p-chlorophenoxy)-2-methylpropionate] (etofylline clofibrate, Duolip) (3 x 250 mg) was evaluated in a double-blind cross-over study in 20 patients of type 11b (10 and type IV (10) in comparison to a commercial drug combination (= standard preparation) of clofibrate (3 x 500 mg) and beta-pyridylcarbinol hydrogentartrate (3 x 25 mg). This standard preparation was known from clinical results to be superior over clofibrate in antilipaemic potency. All patients had been already on a diet for several months and in majority were additionally treated with antihyperlipaemic drugs. The treatment periods lasted over 8 weeks each. They were introduced by placebo phases of 4 weeks duration. Between the treatment periods with etofylline clofibrate and with the standard preparation, placebo phases of 4 weeks were inserted, too. The results indicate, that between etofylline clofibrate and the standard preparation there are no remarkable differences and thus 750 mg etofylline clofibrate correspond to 1500 mg clofibrate combined with 75 mg beta-pyridylcarbinol hydrogentartrate in their efficiencies. Since the clofibric acid proportion of etofylline clofibrate clinically is known as ineffective we postulate a potentiation of its effect by its metabolits to cause this surprising effect. In type IIb the cholesterol was distinctly decreased in the VLDL-fraction by 22% and significantly increased in the HDL-fraction by 22%. In type IV triglycerides and cholesterol dropped in the VLDL by 11% and 16%, resp., unless the LDL-fraction revealed an increase of the lipid content. The lipids of the HDL-fraction did not show any essential alternations. Side effects were not observed. The investigations prove that etofylline clofibrate is suitable for the treatment of hyperlipoproteinaemia with elevated triglycerides and cholesterol.