Abstract | BACKGROUND: METHODS: We conducted a randomized, double-blind, placebo-controlled study of 41 young subjects (age range, 8 to 25 years) who were genotypically affected with familial adenomatous polyposis but phenotypically unaffected. The subjects received either 75 or 150 mg of sulindac orally twice a day or identical-appearing placebo tablets for 48 months. The number and size of new adenomas and side effects of therapy were evaluated every four months for four years, and the levels of five major prostaglandins were serially measured in biopsy specimens of normal-appearing colorectal mucosa. RESULTS: After four years of treatment, the average rate of compliance exceeded 76 percent in the sulindac group, and mucosal prostaglandin levels were lower in this group than in the placebo group. During the course of the study, adenomas developed in 9 of 21 subjects (43 percent) in the sulindac group and 11 of 20 subjects in the placebo group (55 percent) (P=0.54). There were no significant differences in the mean number (P=0.69) or size (P=0.17) of polyps between the groups. Sulindac did not slow the development of adenomas, according to an evaluation involving linear longitudinal methods. CONCLUSIONS:
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Authors | Francis M Giardiello, Vincent W Yang, Linda M Hylind, Anne J Krush, Gloria M Petersen, Jill D Trimbath, Steven Piantadosi, Elizabeth Garrett, Deborah E Geiman, Walter Hubbard, G Johan A Offerhaus, Stanley R Hamilton |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 346
Issue 14
Pg. 1054-9
(Apr 04 2002)
ISSN: 1533-4406 [Electronic] United States |
PMID | 11932472
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Antineoplastic Agents
- Prostaglandins
- Sulindac
- Thromboxane B2
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Topics |
- Adenomatous Polyposis Coli
(genetics, prevention & control)
- Adolescent
- Adult
- Anti-Inflammatory Agents, Non-Steroidal
(adverse effects, therapeutic use)
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Child
- Double-Blind Method
- Female
- Genes, APC
- Humans
- Male
- Mutation
- Patient Compliance
- Prostaglandins
(analysis)
- Rectum
(chemistry, pathology)
- Regression Analysis
- Sulindac
(adverse effects, therapeutic use)
- Thromboxane B2
(analysis)
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