Emmerich K-H, Poritis N, Stelmane I, Klindzane M, Erbler H, Goldsteine J, Görtelmeyer R
Augenklinik, Klinikum Darmstadt, Darmstadt.
Klin Monbl Augenheilkd. 2009 Jul;226(7):561-7. doi: 10.1055/s-0028-1109516. Epub 2009 Jul 30.
Diabetic retinopathy is the leading cause of vision loss or blindeness in working-age adults in the developed and developing countries. No curative treatments are available for diabetic retinopathy and the most common symptomatic treatment, laser photocoagulation, provides only partial and temporary relief from the progressive vascular damage caused by this disease. Etofibrate (Lipo-Merz) is an orally-administered treatment for lipid disorders that combines fibrate and nicotinic acid in a slow-release formulation.
This report describes the results of a double-blind, randomised, placebo-controlled study, performed to evaluate the efficacy and safety of etofibrat in patients with type 2 diabetes mellitus and concomitant diabetic retinopathy. They received either placebo or 1000 mg/day etofibrate for up to 12 months. Efficacy analyses were based on visual acuity assessment and blinded expert ratings of ocular fundus pathology, as well as laboratory analyses of serum lipid parameters.
The evaluable population comprised 296 patients, 148 in each treatment group, of whom 89% completed the study and 73% completed according to protocol. After 12 months of treatment, a significantly larger population of etofibrate-treated patients than placebo-treated patients showed improvements in ocular pathology (46% versus 32%, respectively, p < 0.001); similar findings were already apparent after 6 months of treatment (43% versus 31%, respectively p < 0.001). Etofibrate treatment also produced significant improvements in total cholesterol, LDL-cholesterol and HDL-cholesterol in comparison to the placebo treatment group. Safety evaluations (adverse events, laboratory parameters) did not reveal any clinically significant adverse effects of etofibrate in comparison to placebo.
Etofibrate provides a safe and effective treatment for ocular pathology resulting from type 2 diabetes mellitus.
糖尿病视网膜病变是发达国家和发展中国家劳动年龄成年人视力丧失或失明的主要原因。目前尚无治愈糖尿病视网膜病变的方法，最常见的对症治疗方法——激光光凝术，只能部分且暂时缓解该疾病所导致的进行性血管损伤。依托贝特（Lipo-Merz）是一种口服治疗脂质紊乱的药物，它将贝特类药物和烟酸制成缓释制剂。
本报告描述了一项双盲、随机、安慰剂对照研究的结果，该研究旨在评估依托贝特对2型糖尿病合并糖尿病视网膜病变患者的疗效和安全性。他们接受安慰剂或每日1000毫克依托贝特治疗，为期12个月。疗效分析基于视力评估、眼底病理的盲法专家评分以及血脂参数的实验室分析。
可评估人群包括296名患者，每个治疗组各148名，其中89%完成了研究，73%按照方案完成。治疗12个月后，接受依托贝特治疗的患者中眼部病理改善的人数显著多于接受安慰剂治疗的患者（分别为46%和32%，p<0.001）；治疗6个月后就已出现类似结果（分别为43%和31%，p<0.001）。与安慰剂治疗组相比，依托贝特治疗还使总胆固醇、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇有显著改善。安全性评估（不良事件、实验室参数）未显示依托贝特与安慰剂相比有任何具有临床意义的不良反应。
依托贝特为2型糖尿病所致的眼部病变提供了一种安全有效的治疗方法。
