This study was conducted to address conflicting results regarding the efficacy of fenofibrates in protecting against progression of nonproliferative diabetic retinopathy (NPDR) to vision-threatening DR (VTDR).
Study design
In this medical claim database study, researchers assessed the association between fenofibrate use and development of diabetic macular edema (DME), progression to proliferative diabetic retinopathy (PDR), or progression to vision threatening DR (VTDR, a composite outcome of either PDR or DME), in eyes with baseline non-proliferative DR (NPDR). Exclusion criteria included any previous diagnosis of PDR, DME, or treatment used in the care of VTDR.
Outcomes
A total of 150,252 patients with NPDR were included in the analysis, of which 5835 were using fenofibrates at baseline. Multivariate Cox proportional regression analysis found fenofibrate use to be associated with a decreased risk of VTDR (hazard ratio, 0.92) and decreased risk of PDR (hazard ratio, 0.76). Fenofibrate use was not associated with a decreased risk of DME (hazard ratio, 0.96).
Limitations
Study results are limited by the use of a single claims-based database, which includes the inherent risk of coding or entry errors, and which may not be generalizable to all patients. Analysis based on severity of NPDR (mild vs moderate vs severe) was not conducted, and both new and chronic users of fenofibrates were included.
Clinical significance
Data from this claims-based study further support an association between fenofibrate use and reduced risk of PDR or VTDR. Data from prospective clinical trials data will be of special interest, including clarity regarding any potential effect on DME in addition to progression of DR.