Long-term treatment with sulindac in familial adenomatous polyposis: A prospective cohort study

Background and Aims: Management of patients with familial adenomatous polyposis (FAP) can consist of colectomy with ileorectal anastomosis (IRA). Sulindac, a nonsteroidal anti-inflammatory drug, causes regression of colorectal adenomas in the retained rectal segment of FAP patients, although long-term use of this therapy has not been studied. We evaluated the long-term effectiveness and toxicity of sulindac in attempting to maintain retained rectal segments free of adenomas. Methods: Twelve FAP patients (5 women), mean age 37.1 years, with IRA received sulindac (mean dosage, 158 mg/day) for a mean period of 63.4 ± 31.3 months (range, 14-98 months). Number, size, and histologic grade of polyps, side effects, and medication compliance were assessed every 4 months. Results: Seven of 12 patients (58%) remained in the study (6 of these polyp-free) for a mean of 76.9 ± 27.5 months. Five of 12 patients (42%) withdrew from the trial after a mean follow-up period of 44 ± 28 months (range, 14-89 months). A significant regression of polyp number was observed in all patients at 12 months (P = 0.039) and at a mean of 63.4 ± 31.3 months (P = 0.006). Prevention of recurrence of higher-grade adenomas (tubulovillous, villous adenomas) was also observed (P = 0.004). At 35 months of follow-up, 1 patient developed stage III cancer in the rectal stump. The most common side effect was rectal mucosal erosions in 6 patients. Conclusions: Long-term use of sulindac seems to be effective in reducing polyp number and preventing recurrence of higher-grade adenomas in the retained rectal segment of most FAP patients. Erosions at the IRA site can preclude adequate dose maintenance.