title: Does a selective cyclooxygenase-2 inhibitor (tiracoxib) induce clinically sufficient suppression of adenomas in patients with familial adenomatous polyposis? A randomized double-blind placebo-controlled clinical trial.
abstract: BACKGROUND
  There have been few placebo-controlled randomized double-blind studies of the clinical effects of selective cyclooxygenase-2 (COX-2) inhibitors on the regression of colorectal tumors. This study was designed to examine the regressive effect of a selective COX-2 inhibitor, tiracoxib (JTE-522), on colorectal polyps in patients with familial adenomatous polyposis (FAP), and its safety.
  
  
  METHODS
  Sixty-one patients with FAP diagnosed by Japanese criteria were assigned randomly to receive placebo or JTE-522, at either 150 mg or 200 mg, once daily orally for 26 weeks. Prior to and at the end of the medication period, endoscopy was performed. Adenomas located near an india-ink tattoo injected at the first colonoscopy were identified and measured. The response variables were the percent changes from the baseline in polyp numbers and in specified polyp diameters. Any adverse events that appeared in at least four persons were taken into consideration and compared between the JTE-522 treatment groups and the placebo group.
  
  
  RESULTS
  No change in polyp number (median, 0) was observed in any of the three groups. There were no differences between the placebo group and the two treatment groups in the change in polyp size. JTE-522 was well tolerated.
  
  
  CONCLUSIONS
  Our findings, in keeping with other reports on COX-2 inhibitors, indicated that the inhibition of a COX-2 with a moderate dose of a selective COX-2 inhibitor did not induce clinically sufficient regression of adenomas in patients with FAP in a limited (6-month) medication period.
authors.affiliation: Department of Surgery, Kyoundo Hospital, Sasaki Institute, 1-8 Kanda-Surugadai, Tokyo 101-0062, Japan. iwama@po.kyoundo.jp
authors.forename: Takeo
authors.initials: T
authors.lastname: Iwama
authors.forename: Takayuki
authors.initials: T
authors.lastname: Akasu
authors.forename: Joji
authors.initials: J
authors.lastname: Utsunomiya
authors.forename: Tetsuichiro
authors.initials: T
authors.lastname: Muto
mesh_terms: D011125:Adenomatous Polyposis Coli / Q000188:drug therapy*; D000328:Adult; D003111:Colonic Polyps / Q000188:drug therapy*; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009930:Organic Chemicals / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D009930:Organic Chemicals; C419232:tiracoxib