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 (10/182 (10%) in the aspirin group vs 7/83 (7%) 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.
- Colorectal adenoma
- acetylsalicylic acid
- randomised controlled trial
- cancer prevention
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↵* The APACC study group participants are listed in Appendix 1.
Funding This trial was supported by grants from the French Ministry of Health (PHRC) and AP-HP, from the Association pour la Recherche contre le Cancer (ARC), the Société Nationale Française de Gastroentérologie (SNFGE). A special non-restricted grant was provided by Sanofi-Synthelabo. This trial was supported by public research funds. Lysine acetylsalicylate (Kardegic) and placebo were kindly supplied by Sanofi-Synthelabo. None of the authors or collaborators had any financial relationship with Sanofi-Synthelabo. Funding sources did not interfere at all with trial design, data collection, analysis and interpretation, neither with the writing of the present article nor with the decision to submit it for publication.
Competing interests None.
Patient consent Obtained.
Ethics approval The study protocol was approved by the ethics committee of Saint-Germain-en-Laye Hospital, France.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Data and pathological collection is available for scientific sharing.