Table 1.
Main characteristics of included studies
| Study (author, year) | Population | Interventions | Outcomes of interest for this review | Time point for outcome measurement (months) | Funding/register |
|---|---|---|---|---|---|
|
Chew, 2014 (ACCORD Eye) |
Type 2 diabetes, moderate dislipidemia, established cardiovascular disease or cardiovascular risk factors (n = 1594) |
Group 1: fenofibrate 160 mg/day plus simvastatin (n = 806) Group 2: placebo plus simvastatin (n = 787) |
Incidence of DR (ETDRS) Progression of DR (ETDRS) Progression for proliferative disease (participant referred to photocoagulation). Visual acuity (Logarithm of the Minimum Angle of Resolution, LogMAR) |
48 |
National Heart, Lung, and Blood Institute, National Institutes of Health (NHI), National Institute of Diabetes and Digestive and Kidney Diseases, the National Eye Institute, the national Institute on Aging, Center for Disease Control and Prevention Tablets of fenofibrate, equipments and supplies were provided by a pool of pharmaceutics companies |
| Cullen, 1974 | Non-proliferative diabetic retinopathy (n = 40) |
Group 1: clofibrate 2 g/day (n = 20) Group 2: placebo (n = 20) |
Progression of DR (hard exudates progression, similar to ETDRS). Progression for proliferative disease (participant referred to photocoagulation). Visual acuity (Snellen). Mortality |
24 |
Tablets of clofibrate and placebo were supplied by Imperial Chemical Industries Ltda Ross Foundation, Scotland |
| Emmerich, 2009 | Non-proliferative diabetic retinopathy (n = 296) |
Group 1: etofibrate 1 g/day (n = 148) Group 2: placebo (n = 148) |
Incidence of DR (macular edema) Progression of DR Visual acuity Adverse events (counting of severe and mild events and rate of participants with any adverse events) Mortality |
6 and 12 | None |
| Gupta, 2004 | Non-proliferative diabetic retinopathy with clinically significant macular edema (n = 30) |
Group 1: atorvastatin 10 mg/day (n = 15) Group 2: no intervention (n = 15) Both groups received also Nd Yag Green laser (532 Nm) |
Progression of DR (macular edema, distribution of hard exudates) Visual acuity |
1, 5; 3 and 4, 5 | Not described |
| Keech, 2007 (FIELD Sudy) | Non-proliferative diabetic retinopathy with no clinically significant macular edema; no diabetic retinopathy (n = 1012) |
Group 1: micronised fenofibrate 200 mg/day (n = 512) Group 2: placebo (n = 500) |
Incidence of DR (macular edema) Progression of DR (ETDRS and hard exudates) Progression for proliferative disease (ETDRS) Visual acuity (Snellen) Mortality |
42 and 60 | Laboratories Fournier SCA |
| Massim, 2014 (MacuFen Study) | Non-proliferative diabetic retinopathy with macular edema (n = 110) |
Group 1: fenofibrate 135 mg/day (n = 57) Group 2: placebo (n = 53). |
Progression of DR (ETDRS, edema macular and exudate) Progression for proliferative disease (laser need) Visual acuity (Snellen). Severe adverse events |
12 | Laboratories Fournier SCA (previously Abbott) |
| Narang, 2012 | Non-proliferative diabetic retinopathy with clinically significant macular edema (n = 30) |
Group 1: atorvastatin 20 mg/day (n = 15) Group 2: placebo (n = 15). Both groups received also Nd Yag Green laser (532 Nm) |
Progression of DR (distribution of hard exudates) Visual acuity (Snellen) |
6 | None |
| Sen, 2002 | Non-proliferative diabetic retinopathy with no clinically significant macular edema (n = 50) |
Group 1: simvastatin 20 mg/day (n = 25). Group 2: placebo (n = 25) |
Incidence of DR (macular edema) Progression of DR (fundus eye photography) Visual acuity (Snellen) |
3 and 6 | Ranbaxy Laboratories |
DR diabetic retinopathy, ETDRS Early Treatment Diabetic Retinopathy Research Group