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The analysis additionally suggested the potential benefits of finerenone in the prevention of required ocular interventions.
The potential benefit of finerenone for the delay of progression of non-proliferative diabetic retinopathy (NPDR) as well as in the prevention of required ocular interventions was reported in a new analysis.
Although the analysis was considered exploratory and hypothesis-generating, study investigators noted that further studies may have the power to draw conclusions based on these findings.
“However, these findings suggest that randomized studies with adequate power to detect a potential benefit of finerenone in delaying NPDR progression should be considered, particularly given the lack of alternative options for oral treatment of DR,” wrote study author Peter Rossing, MD, Steno Diabetes Center Copenhagen.
Finerenone is a potent and selective, orally administered, nonsteroidal mineralocorticoid receptor antagonist (MRA). The phase 3 randomized FIDELIO-DKD and FIGARO-DKD trials reported finerenone slowed the progression of chronic kidney disease (CKD) and type 2 diabetes (T2D).
Ophthalmological data from routine examinations were obtained retrospectively from patients with medical history of DR who participated in either trial at selected study centers. Eligible patients were 18 years of age or older with T2D and CKD and treated with RAS.
Eligible patients had a routine examination between 6 months prior and 1 month post-randomization demonstrating treatment-naive NPDR in at least one eye, and at least one subsequent routine ophthalmological examination.
The ReFineDR/DeFineDR analysis’ primary outcome was the progression of NPDR as defined by the occurrence of vision-threatening complications (VTC). VTC is a composite endpoint of anterior segment neovascularization, DME, or progression to PDR in at least one eye up to 2 years after treatment initiation.
From 376 eligible patients, 244 patients were included in the analysis. Of this population, 134 had received at least one dose of finerenone and 110 had received placebo.
The study data show 68.7% (92 of 134) and 71.8% (79 of 110) of patients in the finerenone and placebo groups had mild/moderate NPDR at baseline, respectively. More data show 3.0% (4 of 134) and 10.0% (11 of 110) had severe NPDR, respectively. The mean baseline HbA1c was similar between each group (finerenone: 66.7 mmol/mol [8.25%]; placebo: 65.9 mmol/mol [8.18%]).
At the two-year mark, 3.7% (5 of 134) and 6.4% (7 of 110) of patients in the finerenone and placebo groups had experienced a VTC in at least one eye (difference, −0.026 [95% confidence interval [CI], −0.082, 0.029])
Moreover, the number of VTCs was shown to increase beyond 2 years, with Kaplan-Meier-estimated cumulative incidence probabilities favoring finerenone increasing at 30 months (difference, –0.109 [95% CI, -0.202 to -0.016]) and 36 months (difference, -0.118 [95% CI, -0.229 to -0.007]).
Investigators noted the numerical benefits of finerenone were consistent for time to DME or progression to PDR and in the subgroup of patients with baseline HbA1c ≤58 mmol/mol and >58 mmol/mol (7.5%).
Additionally, the findings suggest fewer patients in the finerenone groups versus the placebo group had required ocular interventions (4 [3.0%] vs. 17 [15.5%]). Cumulative incidence probabilities were reported to favor finerenone at 24, 30, and 36 months.
The study, “Effect of finerenone on occurrence of vision-threatening complications in patients with non-proliferative diabetic retinopathy: pooled analysis of two studies using routine ophthalmological examinations from clinical trial participants (ReFineDR/DeFineDR),” was published in Diabetes, Obesity, and Metabolism.