Study shows fenofibrate reduces need for laser treatment for diabetic retinopathy

November 05, 2007

Treatment with fenofibrate in individuals with type 2 diabetes mellitus reduces the need for laser treatment for diabetic retinopathy (DR), conclude authors of an Article published early Online and in a upcoming edition of The Lancet.

DR has become the leading cause of vision loss and blindness in working-age adults in both developed and developing countries. Pathological changes associated with the condition are strongly related to hyperglycamia in type 2 diabetes. Visual loss results mainly from central macular oedema, and less frequently from proliferative DR.

Professor Tony Keech, NHMRC Clinical Trials Centre, University of Sydney, NSW, Australia, and colleagues from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study did a trial of 9795 patients aged 50-75 years, each with type 2 diabetes mellitus. Eligible patients were randomly assigned to receive fenofibrate 200 mg /day or matching placebo. At each clinic visit, information concerning laser treatment for DR was gathered. In a substudy of 1012 patients, standardised retinal photography was done and photographs were graded with Early Treatment Diabetic Retinopathy Study (ETDRS) criteria to determine the cumulative incidence of DR and its component lesions.

The researchers found that, with an average follow-up of five years, fenofibrate reduced the frequency of first laser treatment for macular oedema by 31% and for proliferative DR by 30%. In the substudy, the fenofibrate reduced the risk of first laser treatment by more than 70%; however the actual number of events was small (23 surgeries in the placebo group versus five in the fenofibrate group).

Fenofibrate is a lipid-modifying agent; yet it did not lead to clinically important differences in HDL-cholesterol concentrations between the fenofibrate group and the placebo group. The authors say: "These findings suggest that the mechanisms of benefit of fenofibrate in diabetic retinopathy must go beyond the effects of this drug on lipid concentrations or to lower blood pressure, and might be conferred mainly by other means."

They conclude: "The substantial benefits of fenofibrate on need for laser treatment for diabetic retinopathy are likely to be additive to those benefits arising from tight control of blood glucose and blood pressure in the management of type 2 diabetes mellitus, and emerge rapidly after treatment is commenced. The retinal benefits argue for consideration of using fenofibrate in the management of diabetic eye disease, and should be considered in the context of other effects reported with fenofibrate in the FIELD study."

In an accompanying Comment, Dr Rafael Simo and Dr Cristina Hernandez, Diabetes Research Unit, Vall d'Hebron University Hospital, Barcelona, Spain, say: "The mechanisms by which fenofibrate exerts its reported benefits are far from being elucidated -- further clinical and experimental studies are needed before fenofibrate can be launched as a new tool in the management of diabetic retinopathy."
Professor Tony Keech, NHMRC Clinical Trials Centre, University of Sydney, NSW, Australia, T) +61 414 625 004 E)

Dr Rafael Simo, Diabetes Research Unit, Vall d'Hebron University Hospital, Barcelona, Spain T) +34 93 4894172/ 609589733 E)


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