TY - JOUR

T1 - Effect of Fenofibrate on Progression of Diabetic Retinopathy

AU - Preiss, David

AU - Logue, Jennifer

AU - Sammons, Emily

AU - Zayed, Mohammed

AU - Emberson, Jonathan

AU - Wade, Rachel

AU - Wallendszus, Karl

AU - Stevens, Will

AU - Cretney, Rosanna

AU - Harding, Simon

AU - Leese, Graham

AU - Currie, Gemma

AU - Armitage, Jane

PY - 2024/8/31

Y1 - 2024/8/31

N2 - BACKGROUNDFindings from cardiovascular outcome trials suggest that fenofibrate therapy may reduce the progression of diabetic retinopathy.METHODSWe 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.RESULTSA 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 m2 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.CONCLUSIONSFenofibrate reduced progression of diabetic retinopathy compared with placebo among participants with early retinal changes.

AB - BACKGROUNDFindings from cardiovascular outcome trials suggest that fenofibrate therapy may reduce the progression of diabetic retinopathy.METHODSWe 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.RESULTSA 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 m2 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.CONCLUSIONSFenofibrate reduced progression of diabetic retinopathy compared with placebo among participants with early retinal changes.

KW - Adult

KW - Aged

KW - Diabetic Retinopathy/drug therapy

KW - Disease Progression

KW - Double-Blind Method

KW - Female

KW - Fenofibrate/therapeutic use

KW - Humans

KW - Hypolipidemic Agents/therapeutic use

KW - Male

KW - Middle Aged

U2 - 10.1056/evidoa2400179

DO - 10.1056/evidoa2400179

M3 - Journal article

C2 - 38905569

VL - 3

SP - EVIDoa2400179

JO - NEJM Evidence

JF - NEJM Evidence

SN - 2766-5526

IS - 8

ER -