Fenofibrate reduces risk of retinopathy
The prospective Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was designed to determine the effect of fenofibrate treatment on coronary heart disease events in patients with diabetes.
A subgroup analysis has found that fenofibrate may protect against diabetic retinopathy.
The study recruited 9,795 patients in Australia, New Zealand and Finland.
It included men and women aged between 50 and 75 years who were over 35 when diagnosed with type 2 diabetes. Patients had total cholesterol of 3.0–6.5mmol/l and no contraindication to lipid-lowering therapy. Patients with pre-existing vascular disease were included.
Patients were randomised to treatment with fenofibrate 200mg a day or placebo and were followed up for an average of five years.
The retinal treatment subgroup analysis included 1,012 patients, of whom 850 were followed up. The aims of the analysis were to determine the need for laser therapy and the ability of fenofibrate to prevent a two-step deterioration in retinopathy status.
The analysis initially confirmed that poor blood glucose control and the development of other microvascular problems are associated with retinopathy. Plasma concentration of lipids did not predict the onset or progression of retinopathy.
Analysis of the subgroup found a significant reduction in the need for first laser therapy in patients treated with fenofibrate (1% of patients compared with 4.6% of patients on placebo, P= <0.001).
The incidence of two-step deterioration did not differ significantly in those who presented with new retinopathy, but was significantly reduced in those with pre-existing disease on fenofibrate compared with placebo (P= 0.004).
For a composite of all significant retinal pathology, fenofibrate was shown to prevent the progression of retinopathy compared with placebo
The primary and secondary results of the FIELD study were published in 2005.1 The study found that fenofibrate did not significantly reduce CHD events, possibly because the high use of statins in the study reduced the effect size.
The only significant difference was that patients on fenofibrate were less likely to undergo revascularisation than patients on placebo.
The study also found that all-cause mortality was higher in patients on fenofibrate compared with placebo.
The authors conclude that treating patients with type 2 diabetes with fenofibrate reduces the need for laser treatment for diabetic retinopathy. This effect does not appear to be related to plasma concentration of lipids.
I shall be discussing with local ophthalmologists whether we should consider treating patients at high risk of damaging retinopathy with fenofibrate.
Keech AC, Mitchell P, Summanen PA et al. Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. Lancet 2007;370:1687-97Reviewer
Dr Matthew Lockyer
GP, Suffolk and hospital practitioner in diabetic medicine