Preiss, David 
ORCID: 0000-0003-3139-1836, Logue, Jennifer, Sammons, Emily, Zayed, Mohammed ORCID: 0000-0001-9816-983X, Emberson, Jonathan ORCID: 0000-0001-7792-9422, Wade, Rachel, Wallendszus, Karl, Stevens, Will, Cretney, Rosanna, Harding, Simon ORCID: 0000-0003-4676-1158 et al (show 3 more authors)
(2024)
Effect of Fenofibrate on Progression of Diabetic Retinopathy.
NEJM evidence, 3 (8).
EVIDoa2400179-.
ISSN 2766-5526, 2766-5526
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Abstract
<h4>Background</h4>Findings from cardiovascular outcome trials suggest that fenofibrate therapy may reduce the progression of diabetic retinopathy.<h4>Methods</h4>We recruited and followed adults with nonreferable diabetic retinopathy or maculopathy using the national Diabetic Eye Screening (DES) program in Scotland. We randomly assigned participants to receive 145-mg fenofibrate tablets or placebo (taken daily or, in those with impaired renal function, on alternate days). The primary outcome was a composite of developing referable diabetic retinopathy or maculopathy (based on Scotland's DES grading scheme) or treatment (intravitreal injection, retinal laser, vitrectomy) for retinopathy or maculopathy.<h4>Results</h4>A total of 1151 participants were randomly assigned to treatment. During a median of 4.0 years, progression to referable diabetic retinopathy or maculopathy, or treatment thereof, occurred in 131 (22.7%) of 576 participants in the fenofibrate group and 168 (29.2%) of 575 in the placebo group (hazard ratio, 0.73; 95% confidence interval [CI], 0.58 to 0.91; P=0.006). In the fenofibrate group compared with the placebo group, the frequencies for any progression of retinopathy or maculopathy were 185 (32.1%) vs. 231 (40.2%); hazard ratio, 0.74; 95% CI, 0.61 to 0.90 and for the development of macular edema were 22 (3.8%) vs. 43 (7.5%); hazard ratio, 0.50; 95% CI, 0.30 to 0.84. Seventeen (3.0%) participants assigned fenofibrate and 28 (4.9%) assigned placebo were given treatment for retinopathy (hazard ratio, 0.58; 95% CI, 0.31 to 1.06). There was no effect on visual function, quality of life, or visual acuity. Trial-averaged estimated glomerular filtration rate was 7.9 (95% CI, 6.8 to 9.1) ml/min/1.73 m<sup>2</sup> lower in participants in the fenofibrate group compared with the placebo group. Serious adverse events occurred in 208 (36.1%) participants allocated fenofibrate and 204 (35.5%) participants allocated placebo.<h4>Conclusions</h4>Fenofibrate reduced progression of diabetic retinopathy compared with placebo among participants with early retinal changes. (Funded by the National Institute for Health and Care Research; ClinicalTrials.gov number, NCT03439345; ISRCTN number, ISRCTN15073006.).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Humans, Diabetic Retinopathy, Disease Progression, Double-Blind Method, Adult, Aged, Middle Aged, Female, Male, Hypolipidemic Agents, Fenofibrate |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 22 Aug 2024 08:52 |
| Last Modified: | 08 Dec 2024 05:23 |
| DOI: | 10.1056/evidoa2400179 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3184017 |
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