Researchers from Baltimore, Maryland, USA, evaluated the long-term effectiveness and toxicity of sulindac in attempting to maintain retained rectal segments free of adenomas in patients with familial adenomatous polyposis (FAP).
A total of 12 FAP patients (5 women, mean age 37 years) with ileorectal anastomosis were included in the study. Each received sulindac (mean dosage, 158 mg/day) for a mean period of 63 months (range, 14-98 months).
Number, size, and histologic grade of polyps, side-effects, and medication compliance were assessed every 4 months.
Of the 12 patients, 7 (58%) remained in the study (6 of these polyp-free) for a mean of 77 months.
The other 5 patients (42%) withdrew from the trial after a mean follow-up period of 44 months (range, 14-89 months).
| Significant regression of polyp number in all patients treated with sulindac at 12 months.
| Gastroenterology |
The researchers observed a significant regression of polyp number in all patients at 12 months and at a mean of 63 months.
Prevention of recurrence of higher-grade adenomas (tubulovillous, villous adenomas) was also observed.
At 35 months of follow-up, 1 patient developed stage III cancer in the rectal stump.
The most common side-effect was found to be rectal mucosal erosions in 6 patients.
Maria Cruz-Correa, of the Johns Hopkins University School of Medicine, Baltimore, said on behalf of her colleagues, "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 ileorectal anastomosis site can preclude adequate dose maintenance," she concluded.