Ziegler W J, Metz G, Specker M
Arzneimittelforschung. 1980;30(11b):2053-8.
The efficacy of 1-(theophyllin-7-yl)-ethyl-2-[2-(p-chlorophenoxy)-2-methylpropionate] (etofylline clofibrate, Duolip) was investigated in 47 hyperlipidaemic patients of type II--V in an open within-patient study. All patients were dietary adapted before the preliminary wash-out period of 4 weeks and received etofylline clofibrate in a dosage of 500 mg/day (2x1 capsule) over 4 weeks, and 750 mg/day (3 x 1 capsule) over further 4 months. Depending on type reductions of cholesterol between 15 and 23% and of triglycerides between 24 and 52% were achieved. The total lipids were reduced, too, between 14 and 31%. Except for type IIb, all reductions were statistically significant. The rate of responders was between 47 and 80%. The higher dose (750 mg) only affected the cases of type III and IV, in which a higher rate of responders was found coinciding with more pronounced lipid level reductions. However, the influence of the treatment duration on this increased activity may play an important role. Etofylline clofibrate did not show any side effects and was well tolerated. This clinical finding coinciding with the results of the preceding pilot study on the human tolerability in 10 volunteers. From all parameters tested only GPT and cholesterol showed significant alterations (reduction).
在一项针对47例II - V型高脂血症患者的开放性自身对照研究中，对1-(茶碱-7-基)-乙基-2-2-(对氯苯氧基)-2-甲基丙酸酯的疗效进行了研究。所有患者在为期4周的初步洗脱期前均调整饮食，并在4周内接受500毫克/天（2×1粒胶囊）的益多酯治疗，在接下来的4个月内接受750毫克/天（3×1粒胶囊）的治疗。根据类型不同，胆固醇降低了15%至23%，甘油三酯降低了24%至52%。总脂质也降低了14%至31%。除IIb型外，所有降低均具有统计学意义。有效率在47%至80%之间。较高剂量（750毫克）仅对III型和IV型患者有影响，在这些患者中发现了更高的有效率，同时血脂水平降低更为明显。然而，治疗持续时间对这种增强活性的影响可能起着重要作用。益多酯未显示任何副作用，耐受性良好。这一临床发现与之前在10名志愿者身上进行的人体耐受性初步研究结果相符。在所有测试参数中，只有谷丙转氨酶和胆固醇显示出显著变化（降低）。
