A study recently published in NEJM Evidence investigated the connection between fenofibrate and the development of diabetic retinopathy (DR).
Give me some background first.
DR is a leading cause of global vision loss. Caused by damage to the retina from high blood sugar originating from diabetes, it is also growing in prevalence.
Prior research displayed indications that fenofibrate, a tablet utilized to lower cholesterol and studied for its cardiovascular disease benefits, might slow the progression of diabetes—and potentially DR.
Now, talk about the study.
Thus, the LENS trial (Lowering Events in Non-proliferative retinopathy in Scotland) was conducted to further investigate these findings.
- Its purpose: Fenofibrate was compared to placebo treatments in a total of 1,151 participants who were treated for a median duration of 4 years.
Who was included in the study?
Recruitment took place from the national Diabetic Eye Screening (DES) program in Scotland, where adults with non-referable DR or maculopathy were selected.
Participants were randomized to either receive 145-mg fenofibrate tablets or placebo. Those with impaired renal function took them on alternate days; otherwise, they were taken daily.
Go into the outcome measures.
The primary measure tracked was the progression to referable DR/maculopathy based on NHS Scotland's grading criteria or treatment (intravitreal injection, retinal laser, vitrectomy) for retinopathy or maculopathy.
Secondary measures included:
- Any progression of DR/maculopathy
- Visual acuity (VA)
- Development of hard exudates or hemorrhages within 1 disc diameter of the macula
- Development of macular edema
- Visual function (according to the VFQ-25 questionnaire)
- Quality of life (QoL; according to the EQ-5D questionnaire)
- Total cost to the health service
- Cost-effectiveness (incremental cost per quality adjusted life year [QALY] gained)
Findings?
Over the 4-year period, the primary outcome measure of treatment or progression was found to occur in:
- 131 (22.7%) of 576 participants in the fenofibrate group
- 168 (29.2%) of 575 in the placebo group
What this means: This displayed a statistically significant 27% reduction in the fenofibrate group in the primary outcome measures (P = 0.006).
Tell me more.
The fenofibrate group was also associated with a lower risk of developing macular edema and any progression of retinopathy or maculopathy.
- Further: No effects were found on visual function, QoL, or VA.
Expert opinion?
Per the study authors: “Diabetic retinopathy remains a leading cause of visual impairment. While maintaining optimal blood glucose levels is crucial, achieving this is often challenging.”
They continued: “Effective and accessible treatments are urgently needed, and fenofibrate appears promising in slowing the progression of diabetic eye disease."
Take home.
Ultimately, the LENS trial confirmed previous belief in a connection between the use of fenofibrate and DR development.
The authors concluded: “Fenofibrate reduced progression of diabetic retinopathy compared with placebo among participants with early retinal changes.”