ORLANDO, Fla. — The old, generic cholesterol drug fenofibrate has shown potential for slowing the progression of diabetic retinopathy in people with early retinal changes, with the potential to reduce the need for retinal laser or intravitreal injection treatment, new trial data suggest.
In the multicenter LENS trial of more than 1100 people randomly assigned to fenofibrate or placebo for 4 years, fenofibrate led to a 27% reduction in the progression of, or treatment for, diabetic retinopathy or maculopathy. The benefit was seen in people with both type 1 and type 2 diabetes and in those with both normal and impaired kidney function.
“We’ll be watching to see what might happen with uptake in routine care with repurposing of an old drug…The point is trying to prevent people from needing [retinal laser and intravitreal injection]. Those treatments have significant downsides. With this drug, if it works, the aim would be to use it early to reduce the numbers of people progressing to need treatment,” lead author David Preiss, PhD, told Medscape Medical News.
Preiss, associate professor at Oxford Population Health, University of Oxford, UK, presented the LENS results June 21 at the American Diabetes Association’s annual Scientific Sessions. The data were published simultaneously in NEJM Evidence.
Fenofibrate’s effects on diabetic retinopathy were seen in two previous cardiovascular outcomes trials: in a 2007 substudy of the 2005 FIELD study and in a 2010 analysis of data from the ACCORD study. LENS is the first dedicated study investigating fenofibrate’s effect on diabetic retinopathy outcomes, Preiss noted.
Asked to comment, session moderator Thomas W. Gardner, MD, professor of ophthalmology and physical sciences and internal medicine at the University of Michigan, Ann Arbor, told Medscape Medical News, “I think this is very encouraging. It totally fits the previous findings…It suggests that the progression of retinopathy can be lowered by not 100%, but by a third, maybe, which is substantial. Every little bit helps. And it can be done with a very safe drug, a very inexpensive drug that’s taken by mouth.”
Gardner added, “Just controlling A1c isn’t the whole story…When people have some microaneurysms or a few small hemorrhages, for which there’s no ocular treatment, then having a systemic therapy like fenofibrate would seem to make a lot of sense.”
Fenofibrate Reduced Progression by 27%
The 16-center trial was embedded into routine clinical care at 11 National Health Service centers in Scotland, from September 2018 through July 2021. A total of 1151 participants with either mild background retinopathy or maculopathy were randomly assigned to receive 145 mg fenofibrate or placebo either daily or every other day in those with impaired kidney function. Complete data were available for 1149 participants. Of those, 27% had type 1 diabetes and 23% had an estimated glomerular filtration rate (eGFR)
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