Cholesterol drug could find new role in diabetic eye disease

A decades-old drug used to lower cholesterol levels in the blood has been shown to reduce the progression of vision-robbing retinopathy in people with diabetes.

Results of the LENS trial carried out in patients enrolled into Scotland’s Diabetic Eye Screening (DES) programme found that, over four years, treatment with fenofibrate resulted in a 27% reduction in the progression of diabetic retinopathy compared to placebo, which was a highly statistically significant difference.

According to Oxford Population Health, which ran the study, it is the first large-scale trial specifically designed to investigate the effect of fenofibrate on eye health in people with early diabetic retinopathy. The results were presented at the American Diabetes Association (ADA) meeting and simultaneously published in the New England Journal of Medicine.

Diabetic retinopathy is a leading cause of sight loss globally, with increasing prevalence in many regions of the world over the last 30 years as rates of diabetes have climbed and a big impact on both patients’ health and wellbeing, as well as societal costs. The condition is caused by high blood sugar levels damaging the blood vessels in the retina.

Treatments are available for retinopathy that is already established, mainly VEGF-directed therapies that shrink swollen blood vessels and relieve swelling in the retina. The LENS study sought, however, to find a way to treat people in the early stages of retinopathy picked up using the routine screening provided to all diabetics aged 12 and over in Scotland, based on imaging of the retina.

In addition to slowing the rate of progression, fenofibrate reduced the chance of any progression of retinopathy requiring treatment and cut the risk of developing swelling in the retina, known as macular oedema, compared to placebo. The benefits of fenofibrate were similar in people with both type 1 and type 2 diabetes and in people with both normal and impaired kidney function.

Dr David Preiss, associate professor at Oxford Population Health and lead author of the study, said fenofibrate could provide a “simple strategy” to reduce the progression of diabetic eye disease that could be deployed at scale.

“Good control of blood glucose is important, but this is very difficult to achieve for many people, and there are few other treatments available,” he said. An added bonus is that, as a very old, generic drug, fenofibrate is very cheap and can be dosed by simply taking daily tablets.

Running the trial in partnership with the Scottish DES also allowed the LENS investigators to collect 9,000 retinal images and these will be analysed using machine learning tools to better understand the effect of fenofibrate in the diabetic eye.

Subjects in the study will also be tracked through linkage to national health records to understand the long-term impacts of fenofibrate therapy on health.

“Eye problems are a frightening and too frequent complication of diabetes [...] but acting early can stop the first signs of damage progressing into devastating sight loss,” said the patient advocacy group Diabetes UK.

“We’re excited by the positive results from this major trial of a new treatment to slow progression of eye damage, which has the potential to benefit many people with diabetes.”

A study published last year estimated that there were 9.6 million people in the US with diabetic retinopathy overall, around 26% of the total diabetic population, and which was vision-threatening in around 1.8 million cases.

Image by Paul Diaconu from Pixabay