The cholesterol drug fenofibrate could help slow down diabetic retinopathy in people with early signs of the disease, reducing the need for more invasive treatments like laser surgery or eye injections.
This was shown in the LENS trial, where over 1,100 participants took either fenofibrate or a placebo for four years. Those on fenofibrate had a 27% lower chance of their eye disease getting worse or needing treatment. This benefit was seen in people with both type 1 and type 2 diabetes, no matter their kidney health.
Lead author David Preiss, PhD, emphasized the potential of fenofibrate to prevent the need for retinal treatments, which have significant downsides, by using the drug early in the disease process.
The findings were presented at the American Diabetes Association’s annual Scientific Sessions and published in NEJM Evidence. Previous studies, including the 2005 FIELD study and the 2010 ACCORD study, also suggested the benefits of fenofibrate for diabetic retinopathy, but LENS is the first study dedicated solely to investigating this effect.
Thomas W. Gardner, MD, commented that the LENS trial results are encouraging and consistent with previous findings, suggesting that fenofibrate can reduce the progression of retinopathy by about a third.
He highlighted the drug’s safety, low cost, and oral administration as significant advantages, particularly for patients with early-stage disease who currently have limited treatment options.
The LENS trial, conducted at 11 National Health Service centers in Scotland from 2018 to 2021, involved participants with mild background retinopathy or maculopathy. They were given 145 mg of fenofibrate or a placebo daily or every other day for those with impaired kidney function.
The primary outcome was a composite measure of developing referable diabetic retinopathy or requiring treatment, which occurred significantly less often in the fenofibrate group compared to the placebo group (22.7% vs. 29.2%).
Fenofibrate also significantly reduced the occurrence of any retinopathy or maculopathy progression and the need for treatment. Macular edema was notably less common in the fenofibrate group (3.8%) compared to the placebo group (7.5%).
However, there were no differences in visual function, quality of life, or visual acuity between the groups, likely because participants had early-stage retinopathy without visual impairment.
Regarding safety, there were no major cardiovascular events or significant differences in nontraumatic lower limb amputations between the groups. Fenofibrate led to a reversible increase in blood creatinine levels, which could be misinterpreted as renal harm, although previous studies suggest it might be renoprotective over the long term.
Future monitoring of eye and kidney function in these participants over the next 10 years is planned, along with additional trials in Australia and the Protocol AF trial in the US to further support fenofibrate’s use in early diabetic retinopathy.
