Effects of aspirin on vitreous/preretinal hemorrhage in patients with diabetes mellitus. Early Treatment Diabetic Retinopathy Study report no. 20
E. Y. Chew, M. L. Klein, R. P. Murphy, N. A. Remaley and F. L. Ferris 3rd
National Eye Institute, National Institutes of Health, Bethesda, Md.
OBJECTIVE: To assess whether the use of aspirin exacerbates the severity or
duration of vitreous/preretinal hemorrhages in patients with diabetic
retinopathy. DESIGN: The Early Treatment Diabetic Retinopathy Study
(ETDRS), a multicenter randomized clinical trial, was designed to assess
the effect of photocoagulation and aspirin on 3711 patients with mild to
severe nonproliferative or early proliferative diabetic retinopathy.
INTERVENTION: Patients were randomly assigned to either an aspirin (650
mg/d) or a placebo group. One eye of each patient was randomly assigned to
early photocoagulation and the other to deferral of photocoagulation. MAIN
OUTCOME MEASURES: The severity and duration of the vitreous/preretinal
hemorrhages were determined from gradings of the annual, seven standard
stereoscopic field, fundus photographs. Clinical examinations scheduled
every 4 months also provided information on the presence and duration of
hemorrhages. RESULTS: Annual fundus photographs of eyes assigned to
deferral of photocoagulation revealed vitreous/preretinal hemorrhages at
some time during follow-up in 564 patients (30%) assigned to the placebo
group and 585 patients (32%) assigned to the aspirin group (P = .48). Based
on gradings of fundus photographs, there were no statistical differences in
the severity of vitreous/preretinal hemorrhages (P = .11) or their rate of
resolution (P = .86) between the groups. Clinical examination of eyes
assigned to deferral of photocoagulation revealed 721 eyes (39%) assigned
to the aspirin group and 689 (37%) assigned to the placebo group that had
vitreous/preretinal hemorrhages during the course of the study (P = .30).
Again, no statistically significant difference was found between the rates
of resolution, as assessed clinically, between the two treatment groups (P
= .43). CONCLUSIONS: As previously reported, the use of aspirin did not
increase the occurrence of vitreous/preretinal hemorrhages in patients
enrolled in the ETDRS. The data presented in this report demonstrate that
the severity and duration of these hemorrhages were not significantly
affected by the use of aspirin and that there were no ocular
contraindications to its use (650 mg/d) in persons with diabetes who
require it for treatment of cardiovascular disease or for other medical
indications.
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Hennekens et al.
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Lowe
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Collaboration
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Christen et al.
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Ong and Kajubi
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Sarraf and Schwartz
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ASPIRIN IS SAFE FOR DIABETICS WITH RETINOPATHY.
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