Effect of Fenofibrate on Progression of Diabetic Retinopathy
Primary result · Progression to referable DR or maculopathy, or its treatmentResult — go to the resultHazard ratio 0.73 95% CI 0.58–0.91Authors' conclusion
Fenofibrate reduced progression of diabetic retinopathy compared with placebo among participants with early retinal changes.
Study context
- Population
- Adults with nonreferable DR or maculopathy, national Diabetic Eye Screening (DES) program, Scotlandrandomised
- Participants
- 1,151 adults
- Comparison
- Fenofibrate 145 mg vs placebo
- Fenofibraten = 576
- Placebon = 575reference
- Primary endpoint
- Composite of developing referable DR or maculopathy (Scotland's DES grading) or treatment (intravitreal injection, retinal laser, vitrectomy) for retinopathy or maculopathy
- Follow-up
- Median 4.0 years
Methodological detailsplacebo-controlled
- Placebo-controlled
Primary result
As reported in the abstract
Progression to referable DR or maculopathy, or its treatment
Hazard ratio
0.73
95% CI 0.58–0.91
P = 0.006
Events by treatment group
Fenofibratevs Placebo
HR 0.73 (95% CI 0.58–0.91); P = 0.006
Further findings
| Outcome | Fenofibrate | Placebo | HR (95% CI) | |
|---|---|---|---|---|
| Any progression of retinopathy or maculopathy | 32.1% | 40.2% | 0.74 (0.61–0.90) | |
| Development of macular edema | 3.8% | 7.5% | 0.50 (0.30–0.84) | |
| Treatment for retinopathy | 3.0% | 4.9% | 0.58 (0.31–1.06) | |
| 0.20.5125Hazard ratio (log scale) |
Visual function, quality of life, visual acuity
- No effect on visual function, quality of life, or visual acuity
Safety
| Outcome | Difference (ml/min/1.73 m²) (95% CI) | |
|---|---|---|
| Trial-averaged eGFRLower with Fenofibrate | 7.9 (6.8–9.1) | |
| −50510Difference, ml/min/1.73 m² (linear scale) |
Serious adverse events
Original publication
Effect of Fenofibrate on Progression of Diabetic Retinopathy. NEJM Evid. Published 21 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →