
Use of aspirin, although safe, does not appear to provide any meaningful beneficial effects for diabetic retinopathy (DR), a study has shown.
Researchers performed a substudy of ASCEND*, a double-masked, randomized, placebo-controlled trial of aspirin 100 mg for the primary prevention of serious cardiovascular events in a total of 15,480 adults with diabetes (aged ≥40 years) in the UK.
Linkage data were obtained from electronic National Health Service Diabetic Eye Screening Programme records in England and Wales, and participant-reported eye events were confirmed through a medical record review. Finally, intention-to-treat analyses of time until the first primary efficacy and safety outcomes were carried out using log-rank methods.
The primary efficacy endpoint was the first record of referable disease after randomization, a composite of referable retinopathy or referable maculopathy. The safety outcome was the first sight-threatening eye bleed, resulting in unresolved visual loss or requiring an urgent intervention such as laser photocoagulation, vitreoretinal surgery, intraocular injection, or a combination thereof.
Of the ASCEND participants, 7,360 were included in this substudy. Among these diabetic patients, 539 (14.6 percent) had a referable disease event in the aspirin group as opposed to 522 (14.2 percent) in the placebo group (rate ratio, 1.03, 95 percent confidence interval [CI], 0.91‒1.16; p=0.64) during a mean follow-up of 6.5 years.
Likewise, no statistically significant difference was observed in the number of sight-threatening eye bleed events between the aspirin and placebo groups (0.7 percent vs 0.8 percent; rate ratio, 0.89, 95 percent CI, 0.62‒1.27).
“These data exclude any clinically meaningful benefits of aspirin for DR but give reassurance regarding the ophthalmologic safety of aspirin,” the researchers said.
*A Study of Cardiovascular Events in Diabetes