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Fenofibrate reduces need for laser retinopathy treatment in diabetic patients
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Treating patients with type 2 diabetes mellitus with fenofibrate reduces the need for laser treatment of diabetic retinopathy, according to the Fenofibrate Intervention and Event Lowering in Diabetes study.
"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," the study authors said.
Of 9,795 patients aged 50 to 75 years, 4,895 were randomly assigned to receive 200 mg of fenofibrate daily and 4,900 were assigned to receive a matching placebo.
In a substudy involving 1,012 patients, the researchers also reviewed standardized retinal photographs, which were graded using the ETDRS criteria to determine the cumulative incidence of diabetic retinopathy and its component lesions, according to the study.
"Laser treatment was needed more frequently in participants with poorer glycemic or blood pressure control than in those with good control of these factors and in those with a greater burden of clinical microvascular disease," the authors said.
However, "the need for such treatment was not affected by plasma lipid concentrations," they noted.
Laser treatment was required significantly less in the fenofibrate group than in the placebo group. Specifically, 164 fenofibrate-treated patients (3.4%) required laser treatment, compared with 238 placebo patients (4.9%; P = .0002), according to the study.
Regarding the substudy, two-step retinopathy grade progression occurred in 46 fenofibrate patients (9.6%) compared with 57 placebo patients (12.3%; P = .19).
In the subset analysis of patients without pre-existing retinopathy, progression occurred in 43 fenofibrate-treated patients (11.4%) and 43 placebo patients (11.7%; P = .87). However, in patients with pre-existing retinopathy, only three fenofibrate patients (3.1%) had two-step progression compared with 14 placebo patients (14.6%; P = .004), according to the study, published in the Nov. 17 issue of The Lancet.