Giardiello et al.,39 in reviewing the role of sulindac with respect to adenomatous polyps in patients with FAP, showed that regression of adenomatous polyps was evident in case reports dating back to 198 3 83 and 1989.84 These observations were also confirmed in randomized studies of sulindac.66'85'86 This evidence prompted them to study the ability of sulindac to prevent adenomas in patients with FAP who were phenotypically normal.39

They performed a randomized, double-blind, placebo-controlled study involving 41 young individuals (ranging in age from 8 to 25 years) who were genotypically affected with FAP but phenotypically unaffected. They were given 75 or 150 mg of sulindac orally twice a day, or identically appearing placebo tablets, for 48 months.39 Care was taken to evaluate the number and size of new colonic adenomas, as well as side effects of therapy in addition to levels of five major prostaglandins, which were serially measured in biopsy specimens of normal-appearing colorectal mucosa. Findings disclosed that following four years of therapy, 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.

These authors concluded that there was no evidence showing that sulindac prevented the development of colonic adenomas in patients with FAP who were phenotypically normal. However, this is clearly a very select group, and the relatively small numbers leaves open the possibility of type II error. The polyps that occur in patients on sulindac appear molecularly distinct,87 although the clinical implications of this finding remain unclear.

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