Patients with Type 2 Diabetes who are treated with fenofibrate do not require laser treatment for diabetic retinopathy (DR) as often as similar patients who do not receive fenofibrate, according to an article in The Lancet.

DR is the foremost cause of blindness and vision loss globally for adults of working age, explain the authors. Pathological changes linked to the condition are closely associated with hyperglycemia in type 2 diabetes. Loss of vision occurs mainly from central macular edema, and less commonly from proliferative DR.

Professor Tony Keech, NHMRC Clinical Trials Centre, University of Sydney, NSW, Australia, and team from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study carried out a trial with 9,795 individuals, aged 50 to 75 years. They all had type 2 diabetes mellitus. They were randomly selected to receive either fenofibrate 200mg per day, or a matching placebo. Data related to laser treatment for DR was collected as patients visited their clinics.

In a sub-study, involving 1,012 individuals, standardized retinal photography was done and photographs were graded with Early Treatment Diabetic Retinopathy Study (ETDRS) criteria to assess the cumulative incidence of DR and its component lesions.

Over a 5-year average follow-up, the researchers found that fenofibrate reduced the frequency of first laser treatment for macular edema by 31%, and for proliferative DR by 30%. The reduction in the risk of having first laser treatment was 70% in the sub-study for those receiving fenofibrate – however, the total number of events was small (23 surgeries in placebo group compared to 5 in the fenofibrate group).

Fenofibrate, a lipid-modifying agent, did not lead to clinically significant variations in HDL-cholesterol concentrations among the fenofibrate and placebo groups, wrote the researchers.

“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 wrote.

“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,” the authors concluded.

Accompanying Comment

“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,” wrote Dr Rafael Simó and Dr Cristina Hernández, Diabetes Research Unit, Vall d’Hebron University Hospital, Barcelona, Spain, in an accompanying Comment.

“Study shows fenofibrate reduces need for laser treatment for diabetic retinopathy”
Professor Tony Keech, et al
The Lancet – Wednesday November 7 2007
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Written by׃ Christian Nrodqvist