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Clinical Trial
. 2006 Mar;55(3):367-73.
doi: 10.1136/gut.2004.061432. Epub 2005 Sep 8.

Sporadic adenomatous polyp regression with exisulind is effective but toxic: a randomised, double blind, placebo controlled, dose-response study

N Arber  1 , S Kuwada, M Leshno, R Sjodahl, R Hultcrantz, D Rex; Exisulind Study Group
Affiliations
Clinical Trial

Sporadic adenomatous polyp regression with exisulind is effective but toxic: a randomised, double blind, placebo controlled, dose-response study

N Arber et al. Gut. 2006 Mar.

Abstract

Background and aims: A 12 month, multicentre, randomised, double blind, placebo controlled, phase 3, dose-response study was carried out. Exisulind inhibits tumour growth by induction of apoptosis. The aim of our study was to investigate if exisulind induces regression of sporadic colonic adenomas.

Patients and methods: A 12 month multicentre randomised double blind placebo controlled phase 3 dose response study was carried out. At baseline colonoscopy, left sided polyps (3-10 mm) were tattooed, measured, and left in place. Subjects received exisulind 200 or 400 mg, or placebo daily. Follow up sigmoidoscopy was performed after six months, and removal of any remaining polyps at the 12 month colonoscopy. The primary efficacy variable was change in polyp size from baseline.

Results: A total of 281 patients were enrolled and randomised; 155 (55%) fulfilled the criteria for the intention to treat (ITT) analysis and 114 (41%) fulfilled the criteria for the efficacy evaluation analysis (patients who underwent the 12 month colonoscopy). The decrease in median polyp size was significantly greater (p=0.03) in patients who received exisulind 400 mg (-10 mm2) compared with those who received placebo (-4 mm2). Complete or partial response was significantly higher in the exisulind 400 mg group (54.6%) compared with the placebo group (30.2%), and disease progression was significantly lower (6.1% v 27.9%) (p=0.04 and 0.02, respectively). Increased liver enzymes (8.4%) and abdominal pain (14.7%) were also reported at a greater frequency in the exisulind 400 mg group.

Conclusion: Exisulind caused significant regression of sporadic adenomatous polyps but was associated with more toxicity. This model of polyp regression, short in its term and involving a comparatively small patient sample size, may be the best available tool to assess a therapeutic regimen before launching into large preventive clinical studies.

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Conflict of interest statement

Conflict of interest: None declared.

References

    1. Bond J H. Polyp guideline: diagnosis, treatment, and surveillance for patients with non‐familial colorectal polyps: the Practice Parameters Committee of the American College of Gastroenterology. Ann Intern Med 1993119836–843. - PubMed
    1. Burt R W, Bishop D T, Lynch H T.et al Risk and surveillance of individuals with colorectal polyps: WHO Collaborative Centre for the Prevention of Colorectal Cancer. Bull World Health Organ 199068789–795. - PMC - PubMed
    1. Colorectal cancer In: Steward BW, Kleihues P, eds. World cancer report. Lyon: IARC Press, 2003198–202.
    1. Stryker S J, Wolff B G, Culp C E.et al Natural history of untreated colonic polyps. Gastroenterology 1987931009–1013. - PubMed
    1. Fearon E R. Molecular genetic studies of the adenoma‐carcinoma sequence. Adv Intern Med 199439123–130. - PubMed

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