The preventive effects of low-dose enteric-coated aspirin tablets on the development of colorectal tumours in Asian patients: a randomised trial.

Abstract

OBJECTIVE:

To evaluate the influence of low-dose, enteric-coated aspirin tablets (100 mg/day for 2 years) on colorectal tumour recurrence in Asian patients with single/multiple colorectal tumours excised by endoscopy.

DESIGN:

A double-blinded, randomised, placebo-controlled multicentre clinical trial was conducted.

PARTICIPANTS:

311 subjects with single/multiple colorectal adenomas and adenocarcinomas excised by endoscopy were enrolled in the study (152 patients in the aspirin group and 159 patients in the placebo group). Enrolment began at the hospitals (n=19) in 2007 and was completed in 2009.

RESULTS:

The subjects treated with aspirin displayed reduced colorectal tumourigenesis and primary endpoints with an adjusted OR of 0.60 (95% CI 0.36 to 0.98) compared with the subjects in the placebo group. Subgroup analysis revealed that subjects who were non-smokers, defined as those who had smoked in the past or who had never smoked, had a marked reduction in the number of recurrent tumours in the aspirin-treated group. The adjusted OR for aspirin treatment in non-smokers was 0.37 (CI 0.21 to 0.68, p<0.05). Interestingly, the use of aspirin in smokers resulted in an increased risk, with an OR of 3.44. In addition, no severe adverse effects were observed in either group.

CONCLUSIONS:

Low-dose, enteric-coated aspirin tablets reduced colorectal tumour recurrence in an Asian population. The results are consistent with those obtained from other randomised controlled trials in Western countries. THE CLINICAL TRIAL REGISTRY WEBSITE AND THE CLINICAL TRIAL NUMBER: http://www.umin.ac.jp (number UMIN000000697).

• Authors: Hideki Ishikawa, Michihiro Mutoh, Sadao Suzuki, Shinkan Tokudome, Yoshihisa Saida, Takashi Abe, Shozo Okamura, Masahiro Tajika, Takashi Joh, Shinji Tanaka, Shin-Ei Kudo, Takahisa Matsuda, Masaki Iimuro, Tomomi Yukawa, Tetsuji Takayama, Yasushi Sato, Kyowon Lee, Shinji Kitamura, Motowo Mizuno, Yasushi Sano, Nobuhisa Gondo, Kenji Sugimoto, Masato Kusunoki, Chiho Goto, Nariaki Matsuura, Toshiyuki Sakai, Keiji Wakabayashi
• Journal: Gut (Gut) Vol. 63 Issue 11 Pg. 1755-9 (Nov 2014) ISSN: 1468-3288 [Electronic] England
• PMID: 24488498 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Chemical References

• Anticarcinogenic Agents
• Cyclooxygenase Inhibitors
• Tablets, Enteric-Coated
• Aspirin

Topics

• Adenocarcinoma (prevention & control)
• Adenoma (prevention & control)
• Adult
• Aged
• Alcohol Drinking (epidemiology)
• Anticarcinogenic Agents (administration & dosage, therapeutic use)
• Aspirin (administration & dosage, therapeutic use)
• Colonic Neoplasms (prevention & control)
• Cyclooxygenase Inhibitors (administration & dosage, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Neoplasm Recurrence, Local (epidemiology)
• Rectal Neoplasms (prevention & control)
• Smoking (epidemiology)
• Tablets, Enteric-Coated