Clinical Development Laboratoires Fournier SA - Solvay Pharmaceuticals Company, Daix, France.
Curr Pharm Biotechnol. 2011 Mar 1;12(3):396-405. doi: 10.2174/138920111794480570.
Diabetic retinopathy (DR) is one of the leading risk factors and causes of blindness worldwide. Tight glucose and blood pressure control has been shown to significantly decrease the risk of development as well as the progression of retinopathy and represents the cornerstone of medical management of DR. The two most threatening complications of DR are diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR). Photocoagulation is standard treatment for both DME and PDR. However, some patients suffer permanent visual loss despite therapy. Treatment with fibrates first showed reduction in hard exudates, an effect subsequently shown with statins in short term studies, in particular two randomized studies in patients with macular edema. In the FIELD study which pre-specified microvascular outcomes, fenofibrate reduced laser treatment for DME or PDR by 31%:164 (3.4%) patients on fenofibrate vs. 238 (4.9%) on placebo (p<0.001). In the ophthalmology sub-study of FIELD, the composite exploratory endpoint of 2-step progression of ETDRS retinopathy grade, macular edema or laser treatment was significantly reduced by 34%: 53 (11.1%) patients on fenofibrate vs. 75 (16.1%) on placebo (p=0.022). Conversely, there was no reduction in laser treatment or reduced progression of retinopathy in two large scale studies of statins where cardiovascular events were significantly reduced. Neither class of lipid-lowering drugs consistently improved visual acuity. In the ACCORD-EYE study, the combination of fenofibrate and simvastatin reduced by 40% the rate of progression of diabetic retinopathy compared with simvastatin alone. Other studies are needed to establish the place of lipid lowering drugs in the treatment of macular edema and the prevention of vision loss.
糖尿病视网膜病变（DR）是全球致盲的主要危险因素和原因之一。严格控制血糖和血压已被证明可显著降低视网膜病变的发展和进展风险，是 DR 医学管理的基石。DR 最具威胁性的两种并发症是糖尿病性黄斑水肿（DME）和增生性糖尿病性视网膜病变（PDR）。光凝术是 DME 和 PDR 的标准治疗方法。然而，尽管进行了治疗，仍有一些患者永久性视力丧失。首先用贝特类药物治疗显示出硬性渗出物减少，随后在短期研究中用他汀类药物显示出同样的效果，特别是在黄斑水肿患者的两项随机研究中。在预先规定微血管结局的 FIELD 研究中，非诺贝特可使 DME 或 PDR 的激光治疗减少 31%：非诺贝特组 164 例（3.4%），安慰剂组 238 例（4.9%）（p<0.001）。在 FIELD 的眼科子研究中，2 步 ETDRS 视网膜病变分级、黄斑水肿或激光治疗的复合探索性终点显著降低 34%：非诺贝特组 53 例（11.1%），安慰剂组 75 例（16.1%）（p=0.022）。相反，在两项他汀类药物的大型研究中，尽管心血管事件显著减少，但激光治疗或视网膜病变进展均未减少。两类降脂药物均未一致改善视力。在 ACCORD-EYE 研究中，与单独使用辛伐他汀相比，非诺贝特和辛伐他汀联合使用可使糖尿病视网膜病变的进展率降低 40%。还需要其他研究来确定降脂药物在治疗黄斑水肿和预防视力丧失中的地位。
