Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial

Anthony Keech, Paul Mitchell, Paula Summanen, Justin O'Day, Timothy M E Davis, Michelle Moffitt, Mervi Taskinen, R John Simes, David Tse, Elizabeth Williamson, Alistair Merrifield, Tiina Laatikainen, Michael D'Emden, Dominique Crimet, RL O'Connell, Peter Colman

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Abstract

Summary Background Laser treatment for diabetic retinopathy is often associated with visual field reduction and other ocular side-effects. Our aim was to assess whether long-term lipid-lowering therapy with fenofibrate could reduce the progression of retinopathy and the need for laser treatment in patients with type 2 diabetes mellitus. Methods The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was a multinational randomised trial of 9795 patients aged 50a??75 years with type 2 diabetes mellitus. Eligible patients were randomly assigned to receive fenofibrate 200 mg/day (n=4895) or matching placebo (n=4900). At each clinic visit, information concerning laser treatment for diabetic retinopathya??a prespecified tertiary endpoint of the main studya??was gathered. Adjudication by ophthalmologists masked to treatment allocation defined instances of laser treatment for macular oedema, proliferative retinopathy, or other eye conditions. In a substudy of 1012 patients, standardised retinal photography was done and photographs graded with Early Treatment Diabetic Retinopathy Study (ETDRS) criteria to determine the cumulative incidence of diabetic retinopathy and its component lesions. Analyses were by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN64783481. Findings Laser treatment was needed more frequently in participants with poorer glycaemic or blood pressure control than in those with good control of these factors, and in those with a greater burden of clinical microvascular disease, but the need for such treatment was not affected by plasma lipid concentrations. The requirement for first laser treatment for all retinopathy was significantly lower in the fenofibrate group than in the placebo group (164 [3A?4 patients on fenofibrate vs 238 [4A?9 on placebo; hazard ratio [HR] 0A?69, 95 CI 0A?56a??0A?84; p=0A?0002; absolute risk reduction 1A?5 [0A?7a??2A?3]). In the opht
Original languageEnglish
Pages (from-to)1687 - 1697
Number of pages11
JournalThe Lancet
Volume370
Issue number9600
DOIs
Publication statusPublished - 2007

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