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March 2003

AREDS Misses on Safety

Arch Ophthalmol. 2003;121(3):416-417. doi:10.1001/archopht.121.3.416

I have read with interest the article pertaining to the Age-Related Eye Disease Study (AREDS) in the October 2001 issue of the ARCHIVES.1 However, I believe that while the results are of clinical interest, the findings of the AREDS pertaining to age-related macular degeneration (AMD) should be interpreted with caution.

Although inorganic trace elements and vitamins are essential nutrients required for health maintenance, it is erroneous to address the use of such entities as therapeutics without a clear understanding and appreciation of their relevant pharmacokinetic and pharmacodynamic properties. Furthermore, consideration of factors such as biological variability and dose-response, which express therapeutic action in terms of efficacy as well as toxicity, are in large part poorly defined within the AREDS study design. Characterization of the pharmacologic response to various high-dose vitamin and nutrient administration requires stringent assessment of population-, disease-, and formulation-specific variables that may influence the occurrence of adverse effects in ways not described in the AREDS.