TY - JOUR
T1 - Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial
AU - Keech, Anthony
AU - Mitchell, Paul
AU - Summanen, Paula
AU - O'Day, Justin
AU - Davis, Timothy M E
AU - Moffitt, Michelle
AU - Taskinen, Mervi
AU - Simes, R John
AU - Tse, David
AU - Williamson, Elizabeth
AU - Merrifield, Alistair
AU - Laatikainen, Tiina
AU - D'Emden, Michael
AU - Crimet, Dominique
AU - O'Connell, RL
AU - Colman, Peter
PY - 2007
Y1 - 2007
N2 - 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
AB - 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
UR - http://www.thelancet.com/journals/lancet/.../PIIS0140-6736(07)61607-9
UR - https://www.scopus.com/pages/publications/36049001784
U2 - 10.1016/S0140-6736(07)61607-9
DO - 10.1016/S0140-6736(07)61607-9
M3 - Article
SN - 0140-6736
VL - 370
SP - 1687
EP - 1697
JO - The Lancet
JF - The Lancet
IS - 9600
ER -
