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Previous Volume 328:1313-1316 May 6, 1993 Number 18 Next

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ABSTRACT

Background Familial adenomatous polyposis is an autosomal dominant disorder characterized by the formation of hundreds of colorectal adenomas and eventual colorectal cancer. Administration of the nonsteroidal antiinflammatory drug sulindac has been followed by regression of polyps in patients with this disorder, but no controlled trial of this drug in patients who have not had surgery has been reported.

Methods We conducted a randomized, double-blind, placebo-controlled study of 22 patients with familial adenomatous polyposis, including 18 who had not undergone colectomy. The patients received sulindac at a dose of 150 mg orally twice a day for nine months or identical-appearing placebo tablets. The number and size of the polyps were evaluated every three months for one year.

Results A statistically significant decrease in the mean number of polyps and their mean diameter occurred in patients treated with sulindac, as compared with those given placebo. When treatment was stopped at nine months, the number of polyps had decreased to 44 percent of base-line values and the diameter of the polyps to 35 percent of base-line values (P = 0.014 and P<0.001, respectively, for the comparison with the changes in the group given placebo). No patient had complete resolution of polyps. Three months after treatment with sulindac was stopped, both the number and the size of the polyps increased in sulindac-treated patients but remained significantly lower than the values at base line. No side effects from sulindac were noted.

Conclusions Sulindac reduces the number and size of colorectal adenomas in patients with familial adenomatous polyposis, but its effect is incomplete, and it is unlikely to replace colectomy as primary therapy.

Source Information

From the Departments of Medicine (F.M.G., A.J.K, L.M.H.) and Pathology (S.R.H., C.R.R.) and the Oncology Center (F.M.G., S.R.H., S.P., P.C., S.V.B.), Johns Hopkins University School of Medicine and Hospital, Baltimore; and the Department of Pathology, Academic Medical Center, Amsterdam, the Netherlands (G.J.A.O.).

Address reprint requests to Dr. Giardiello at the Gastroenterology Division, Blalock 935, Johns Hopkins Hospital, 600 N. Wolfe St., Baltimore, MD 21287.

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