Fenofibrate is the first and only widely available lipid modifying agent to demonstrate significant protection to the eye of patients with type 2 diabetes, reducing the need for laser therapy in a wide spectrum of patients which should decrease the risk of progressive loss of vision.
These effects appear independent from blood glucose as well as baseline lipid levels, and are not explained by blood pressure values.
These important, new results are published online in the Lancet by investigators from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study.
Analyses of the results show that fenofibrate:
- Significantly reduces the requirement for a first laser treatment for diabetic eye disease
- 31 per cent overall (p = 0.0002)
- 31 per cent (p = 0.002) for maculopathy, a major cause of blindness
- 30 per cent for proliferative retinopathy (p=0.015).
- Significantly decreases the total number of laser therapies by 37 per cent (p = 0.0003).
Additionally, fenofibrate almost halved (49 per cent, p=0.0002) the need for laser therapies in patients who were not known to have diabetic eye disease at study entry when considering all courses of laser therapy.
These protective effects appear to begin after only eight months of treatment and increase throughout the five-year treatment period.
Fenofibrate also demonstrated, in a sub-study, a significant reduction in the progression of eye disease with a:
- 34 per cent reduction in a combined exploratory endpoint (progression of retinopathy grading by 2 steps, development of macular oedema and one or more laser treatments, 16.1% vs. 11.1% - HR 0.66, 95% CI 0.47-0.94; p=0.022).
- Reduction by 79 per cent of the progression of existing retinopathy (14 cases with placebo, 14.6% vs. 3 cases with fenofibrate, 3.1% p=0.004).
- Several other endpoints did not differ significantly between groups such as the occurrence of new retinopathy, of hard exudates or worsening in visual acuity.
These new results from the FIELD trial conducted in Australia, New Zealand and Finland, come from an analysis of the reasons for the reduction in laser therapy reported in the initial FIELD publication and a pre-specified ophthalmology sub-study of the effect of fenofibrate on the progression of diabetic retinopathy in 1,012 patients who had repeated eye examinations.
Lead investigator of FIELD, Professor Anthony Keech of the NHMRC Clinical Trials Centre, University of Sydney, Australia, said: "For the first time we have shown that a widely available lipid modifying agent, fenofibrate, reduces the complications of diabetic eye disease - the major cause of impaired vision in adults in the industrialised world."
"Importantly, the study also demonstrates that patients without prior known diabetic eye disease (but probably already at early stage of retinopathy) gain significantly from fenofibrate.
In this group the subsequent need for total laser therapy was almost halved. Therefore, we can now hope that we can intervene to significantly reduce the progression of retinopathy before it requires laser treatment."
Importance for millions of diabetics
Eye disease, including diabetic retinopathy and macular oedema, affects up to 50 million of the 200 million people with diabetes worldwide, as after about 10 years of diabetes most patients will experience clinically significant changes in their vision.
Even with intensive multifactorial therapy (antihypertensive agents, oral antidiabetic agents, statins) retinopathy either developed or progressed in about half of patients with type 2 diabetes within eight years (STENO 2 study).