Fenofibrate can reduce diabetic retinopathy surgery

By Martha Kerr

ORLANDO, Florida (Reuters Health) - Among patients with type 2 diabetes, fenofibrate therapy is associated with a significant reduction in the need for laser surgery for retinopathy over a 5-year period, compared with placebo treatment.

In the Fenofibrate Intervention and Event-Lowering in Diabetes (FIELD) trial, 9,795 patients between the ages of 50 and 75 years old with type 2 diabetes were randomly assigned to treatment with fenofibrate or placebo.

The results were presented here at the American Heart Association's Scientific Sessions 2007 by Dr. Anthony Keech of the University of Sydney in Australia.

Fenofibrate, also known by the trade names Lofibra and TriCor, is a cholesterol-lowering drug designed to reduce the fat accumulation along the walls the arteries.

As the patients were followed, the researchers looked for signs of diabetic retinopathy, which often occurs as the disease progresses and the small blood vessels in the eye that supply the retina begin to deteriorate. Tiny hemorrhages occur, the vessels leak and swell, resulting in the progressive loss of vision.

After 5 years of follow-up, "there was a 31 percent reduction in risk of laser surgery with fenofibrate therapy," Keech told Reuters Health. Specifically, 3.4 percent of patients receiving fenofibrate and 4.9 percent receiving the placebo required laser surgery for retinopathy.

In a subset of 1,012 patients who had retinopathy at the beginning of the trial, 9.6 percent on fenofibrate required laser surgery compared with 12.3 percent of those on placebo, for a similar reduction in risk compared with the group as a whole, Keech added.

The results of the FIELD study are being released online by The Lancet to coincide with Keech's meeting presentation.

"These results are very striking," Keech said. "Laser surgery isn't curative and it leaves a scar. In contrast, fenofibrate appears to slow disease progression," he noted.

"The benefit (with fenofibrate) is very rapid, occurring within eight months," he added.

While the benefits were greatest in patients with good blood sugar control, there was still some gain in those with higher than normal blood sugar levels.

This suggests that fenofibrate's mechanism of action is completely different from the system that keeps blood sugar in balance, he commented. "It may have an anti-inflammatory or an antioxidant effect." Animal studies have shown that the drug reduces the death of the cells that line the inside of the retinal vessels.

"The finding on the reduction in need for laser surgery (with fenofibrate) is most likely going to change the way diabetics are managed," Keech predicted.

SOURCE: The Lancet 2007.