Preventing diabetic retinopathy in type 2 diabetes: Do recent trials provide sufficient evidence to change standards of care?

1. Paul Mitchell¹
2. Tien Y Wong²
3. Anthony Keech³

¹Centre for Vision Research, Westmead Millennium Institute, University of Sydney
²Singapore Eye Research Institute, Singapore
³NHMRC Clinical Trials Centre, University of Sydney

Purpose: To evaluate overall influences of fenofibrate on progression of diabetic retinopathy (DR) in type 2 diabetes (T2DM) in the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) and ACCORD (Action to Control Cardiovascular Risk in Diabetes) trials.

Methods: Combined analysis of the FIELD (main + substudy), and ACCORD-Eye databases included 11,388 T2DM patients, of whom 5,701 were treated with fenofibrate (± statin) for up to 5 years. DR progression was defined in the in FIELD substudy (post hoc analysis) as a composite of ≥2 steps on ETDRS retinopathy scale, macular oedema or laser treatment. In ACCORD-EYE, it was defined as ≥3 steps on ETDRS scale or proliferative DR that needed either laser or vitrectomy treatment.

Results: The main FIELD study showed significant reduction with fenofibrate in first laser treatment for retinopathy (absolute risk reduction [ARR] 1.5%, P=0.0002). Fenofibrate also reduced DR progression similarly in both the FIELD substudy: ARR 5.0% (NNT=20, P=0.022) and in ACCORD-EYE, ARR 3.7% (NNT=27, P=0.006). In the FIELD substudy, fenofibrate effects were greater in patients with pre-existing DR (interaction, P=0.019). For those with DR, the ARR with fenofibrate was 11.5% (NNT=9) versus 0.3% in those without DR. Data were similar for ACCORD-EYE, ARR 6.9% (NNT=14) for those with DR, and 0.2% in people without DR, but the interaction was not significant after adjusting for the multiple tests.

Conclusions: Because of the prevalence of DR, including at diagnosis, adding fenofibrate to current standards of care for T2DM could help reduce the substantial burden of DR.