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Therapeutics
Aspirin prevented new colorectal adenomas in patients with previous colorectal cancer

https://doi.org/10.1136/ebm.8.6.179

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    (2003) N Engl J Med 348, 883. Sandler RS, Halabi S, Baron JA, et al.. A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer.. ;. :. –90.
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 QUESTION: In patients with previous colorectal cancer, is aspirin effective for preventing the occurrence of new colorectal adenomas?

    Design

    Randomised (allocation concealed*), blinded (investigators, patients, clinicians, data collectors, and outcome assessors),* placebo controlled trial with median follow up of 31 months (The Colorectal Adenoma Prevention Study).

    Setting

    39 cancer centres in the US.

    Patients

    635 patients who were 30–80 years of age (mean age 62 y, 52% men) and previously had curative resection of early stage colon or rectal cancer and colonoscopy to the caecum with removal of all polyps within 4 months before study entry. Exclusion criteria included recent use of aspirin or non-steroidal anti-inflammatory drugs, poor general health, expected survival <5 years, pregnancy or nursing, familial polyposis, invasive cancer, and cardiovascular disease. Follow up was 81%.

    Intervention

    After a 3 month run in period, patients were allocated to enteric coated aspirin, 325 mg/day (n=317), or identical placebo (n=318).

    Main outcome measures

    Primary outcomes were the detection of adenomas after randomisation, time to detection of a first adenoma, and proportion with advanced adenomas (≥1 cm in diameter or villous components).

    Main results

    The aspirin and placebo groups had a similar mean …

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    Footnotes

    • Abstract and commentary also appear in ACP Journal Club.

    • Source of funding: National Institutes of Health and aspirin and placebo tablets provided by Bayer.

    • For correspondence: Dr R S Sandler, University of North Carolina, Chapel Hill, NC, USA. E-mail rsandler{at}med.unc.edu

    • ↵* See glossary.