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The preventive effects of low-dose enteric-coated aspirin tablets on the development of colorectal tumours in Asian patients: a randomised trial
  1. Hideki Ishikawa1,
  2. Michihiro Mutoh2,
  3. Sadao Suzuki3,
  4. Shinkan Tokudome3,4,
  5. Yoshihisa Saida5,
  6. Takashi Abe6,
  7. Shozo Okamura7,
  8. Masahiro Tajika8,
  9. Takashi Joh9,
  10. Shinji Tanaka10,
  11. Shin-ei Kudo11,
  12. Takahisa Matsuda12,
  13. Masaki Iimuro13,14,
  14. Tomomi Yukawa13,
  15. Tetsuji Takayama15,
  16. Yasushi Sato16,
  17. Kyowon Lee17,
  18. Shinji Kitamura18,
  19. Motowo Mizuno19,
  20. Yasushi Sano20,
  21. Nobuhisa Gondo21,
  22. Kenji Sugimoto22,
  23. Masato Kusunoki23,
  24. Chiho Goto24,
  25. Nariaki Matsuura25,
  26. Toshiyuki Sakai1,
  27. Keiji Wakabayashi26
  1. 1Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan
  2. 2Division of Cancer Prevention Research, National Cancer Center Research Institute, Tokyo, Japan
  3. 3Department of Public Health, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan
  4. 4National Institute of Health and Nutrition, Tokyo, Japan
  5. 5Toho University Ohashi Medical Center, Tokyo, Japan
  6. 6Department of Gastroenterology, Takarazuka Municipal Hospital, Hyogo, Japan
  7. 7Department of Internal Medicine, Toyohashi Municipal Hospital, Aichi, Japan
  8. 8Department of Endoscopy, Aichi Cancer Center Hospital, Aichi, Japan
  9. 9Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan
  10. 10Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan
  11. 11Digestive Disease Center Northern Yokohama Hospital Showa University, School of Medicine, Kanagawa, Japan
  12. 12Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan
  13. 13Higashisumiyoshi Morimoto Hospital, Osaka, Japan
  14. 14Department of Lower Gastroenterology, Hyogo College of Medicine, Hyogo, Japan
  15. 15Department of Gastroenterology and Oncology, Institute of Health Biosciences, The University of Tokushima Graduate School, Tokushima, Japan
  16. 164th Department of Internal Medicine, Sapporo Medical University, School of Medicine, Hokkaido, Japan
  17. 17Moriguchi Keijinkai Hospital, Osaka, Japan
  18. 18Department of Gastroenterology, Sakai City Hospital, Osaka, Japan
  19. 19Department of Internal Medicine, Hiroshima City Hospital, Hiroshima, Japan
  20. 20Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan
  21. 21Kimura Hospital, Hyogo, Japan
  22. 22Sugimoto Kenji Clinic, Osaka, Japan
  23. 23Department of Gastrointestinal and Pediatric Surgery Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine, Mie, Japan
  24. 24Department of Health and Nutrition, Nagoya-Bunri University, Aichi, Japan
  25. 25Department of Functional Diagnostic Science, Osaka University Graduate School of Medicine, Osaka, Japan
  26. 26Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, Shizuoka, Japan
  1. Correspondence to Dr Michihiro Mutoh, Division of Cancer Prevention Research, National Cancer Center Research Institute, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan; mimutoh{at}ncc.go.jp

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).

  • Aspirin
  • Chemoprevention
  • Alcohol
  • Colonic Polyps

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