Prevention by daily soluble aspirin of colorectal adenoma recurrence: 4-year results of the APACC randomised trial

Gut. 2012 Feb;61(2):255-61. doi: 10.1136/gutjnl-2011-300113. Epub 2011 Sep 2.


Background: Aspirin inhibits colorectal carcinogenesis. In a randomised double-blind placebo-controlled trial, daily soluble aspirin significantly reduced recurrence of colorectal adenomas at 1-year follow-up. In this study the results of daily intake of low-dose aspirin on polyp recurrence at 4-year follow-up are presented.

Methods: 272 patients (naive for chronic aspirin use) with colorectal adenomas were randomly assigned to treatment with lysine acetylsalicylate 160 mg/day (n=73) or 300 mg/day (n=67) or placebo (n=132) for 4 years. The primary endpoints were adenoma recurrence and adenomatous polyp burden at year 4, comparing aspirin at either dose with placebo. The same endpoints were also assessed at year 1 or 4 (last colonoscopy performed for each patient).

Results: At the final year 4 colonoscopy the analysis included 185 patients (55 receiving aspirin 160 mg/day, 47 aspirin 300 mg/day and 83 placebo). There was no difference in the proportion of patients with at least one recurrent adenoma between patients receiving aspirin at either dose and those treated with placebo (42/102 (41%) vs 33/83 (40%); NS) or in the adenomatous polyp burden (3.1 ± 5.8 mm vs 3.4 ± 6.2 mm; NS). Also, the proportion of patients with at least one advanced recurrent adenoma did not differ (10/102 [corrected] (10%) in the aspirin group vs 7/83 (8.4%) [corrected] in the placebo group; NS).

Conclusion: Daily low-dose aspirin decreased adenoma recurrence significantly at 1 year but not at year 4. This discrepancy might be explained by a differential effect of aspirin according to the natural history of the polyp.

Trial registration number: NCT 00224679.

Trial registration: NCT00224679.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenoma / prevention & control
  • Adenomatous Polyps / pathology
  • Adenomatous Polyps / prevention & control*
  • Aged
  • Aspirin / analogs & derivatives*
  • Aspirin / therapeutic use
  • Colonoscopy
  • Colorectal Neoplasms / pathology
  • Colorectal Neoplasms / prevention & control*
  • Cyclooxygenase Inhibitors / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Lysine / analogs & derivatives*
  • Lysine / therapeutic use
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Secondary Prevention
  • Treatment Outcome


  • Cyclooxygenase Inhibitors
  • Lysine
  • Aspirin
  • acetylsalicylic acid lysinate

Associated data