TY - JOUR
T1 - Treatment of Colonic and Rectal Adenomas with Sulindac in Familial Adenomatous Polyposis
AU - Giardiello, Francis M.
AU - Hamilton, Stanley R.
AU - Krush, Anne J.
AU - Piantadosi, Steven
AU - Hylind, Linda M.
AU - Celano, Paul
AU - Booker, Susan V.
AU - Robinson, C. Rahj
AU - Offerhaus, G. Johan A.
N1 - Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 1993/5/6
Y1 - 1993/5/6
N2 - 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., Familial adenomatous polyposis is an autosomal dominant disorder characterized by the formation of hundreds of colorectal adenomas in young adults1,2. This condition is due to a germline alteration of the adenomatous polyposis coli gene on the long arm of chromosome 53–6. Virtually all patients with familial adenomatous polyposis will have colorectal cancer by the fifth decade of life if prophylactic colectomy is not performed1. The regression of rectal adenomatous polyps in patients with familial adenomatous polyposis who were treated with sulindac (Clinoril), a nonsteroidal antiinflammatory drug (NSAID) that inhibits the synthesis of prostaglandin, was reported…
AB - 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., Familial adenomatous polyposis is an autosomal dominant disorder characterized by the formation of hundreds of colorectal adenomas in young adults1,2. This condition is due to a germline alteration of the adenomatous polyposis coli gene on the long arm of chromosome 53–6. Virtually all patients with familial adenomatous polyposis will have colorectal cancer by the fifth decade of life if prophylactic colectomy is not performed1. The regression of rectal adenomatous polyps in patients with familial adenomatous polyposis who were treated with sulindac (Clinoril), a nonsteroidal antiinflammatory drug (NSAID) that inhibits the synthesis of prostaglandin, was reported…
UR - http://www.scopus.com/inward/record.url?scp=0027197062&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0027197062&partnerID=8YFLogxK
U2 - 10.1056/NEJM199305063281805
DO - 10.1056/NEJM199305063281805
M3 - Article
C2 - 8385741
AN - SCOPUS:0027197062
SN - 0028-4793
VL - 328
SP - 1313
EP - 1316
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 18
ER -