Elsevier

Ophthalmology

Volume 116, Issue 12, December 2009, Pages 2386-2392
Ophthalmology

Original article
Low-Dose Aspirin and Medical Record–Confirmed Age-related Macular Degeneration in a Randomized Trial of Women

https://doi.org/10.1016/j.ophtha.2009.05.031Get rights and content

Objective

To test whether alternate-day low-dose aspirin affects incidence of age-related macular degeneration (AMD) in a large-scale randomized trial of women.

Design

Randomized, double-masked, placebo-controlled trial.

Participants

Thirty-nine thousand eight hundred seventy-six healthy female health professionals aged 45 years or older.

Intervention

Participants were assigned randomly to receive either 100 mg aspirin on alternate days or placebo and were followed up for the presence of AMD for an average of 10 years.

Main Outcome Measures

Incident AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-report confirmed by medical record review.

Results

After 10 years of treatment and follow-up, there were 111 cases of AMD in the aspirin group and 134 cases in the placebo group (hazard ratio, 0.82; 95% confidence interval, 0.64–1.06).

Conclusions

In a large-scale randomized trial of female health professionals with 10 years of treatment and follow-up, low-dose aspirin had no large beneficial or harmful effect on risk of AMD.

Financial Disclosure(s)

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Section snippets

Study Design

The WHS was a randomized, double-blind, placebo-controlled, 2×2 factorial trial testing low-dose aspirin (100 mg every other day) and vitamin E in the primary prevention of cardiovascular disease and cancer among 39 876 female health professionals aged 45 years or older.30, 31 A third component, β-carotene, was terminated early in January 1996 after a median treatment duration of 2.1 years.32, 33 Baseline information included height, weight, history of cigarette smoking, history of alcohol use,

Results

The baseline characteristics of participants in the aspirin and placebo groups are shown in Table 1. As expected in this large, randomized trial, baseline characteristics were distributed equally between the 2 treatment groups.

During an average of 10 years of treatment and follow-up, a total of 245 cases of visually significant AMD were confirmed. More than 80% of these cases were characterized by some combination of drusen and RPE changes at the time vision was first noted to be 20/30 or

Discussion

In this large randomized trial, women assigned to alternate-day treatment with low-dose aspirin and followed up for an average of 10 years had a nonsignificant 18% reduced risk of visually significant AMD compared with women assigned to placebo. The 95% CI around this estimate could not rule out a possible beneficial effect as large as 36%, or a small harmful effect of 6% or less. Aspirin treatment seemed to have little effect on the end points of advanced AMD or all AMD cases with or without

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    • Baseline characteristics and age-related macular degeneration in participants of the “ASPirin in Reducing Events in the Elderly” (ASPREE)-AMD trial

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      However, aspirin could also exacerbate retinal hemorrhages in late AMD [16–21]. Consistent with this paradox, previous observational and experimental studies in AMD have reported differing results related to risks and benefits of aspirin [14–19,21–34]. Meta-analyses have similarly not yielded definitive conclusions [20,35–37].

    • The Relationship Between Nonsteroidal Anti-inflammatory Drug Use and Age-related Macular Degeneration

      2018, American Journal of Ophthalmology
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      Neither study demonstrated a significant difference in AMD risk with aspirin use. When data from both studies were combined there was a statistically insignificant trend toward an 18% reduction in the risk of visually significant AMD.5,14 Both studies examined healthcare professionals who may not be representative of the general population owing to their theoretical inclination for healthier lifestyles.15

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    Available online: October 7, 2009.

    Manuscript no. 2008-1509.

    Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

    Supported by the National Institutes of Health, Bethesda, Maryland (grant nos.: CA47988, HL43851, and EY06633). Pills and packaging were provided by Bayer Healthcare and the Natural Source Vitamin E Association.

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