Document Detail

High-dose ursodeoxycholic acid is associated with the development of colorectal neoplasia in patients with ulcerative colitis and primary sclerosing cholangitis.
MedLine Citation:
PMID:  21556038     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: Some studies have suggested that ursodeoxycholic acid (UDCA) may have a chemopreventive effect on the development of colorectal neoplasia in patients with ulcerative colitis (UC) and primary sclerosing cholangitis (PSC). We examined the effects of high-dose (28-30 mg/kg/day) UDCA on the development of colorectal neoplasia in patients with UC and PSC.
METHODS: Patients with UC and PSC enrolled in a prior, multicenter randomized placebo-controlled trial of high-dose UDCA were evaluated for the development of colorectal neoplasia. Patients with UC and PSC who received UDCA were compared with those who received placebo. We reviewed the pathology and colonoscopy reports for the development of low-grade or high-grade dysplasia or colorectal cancer.
RESULTS: Fifty-six subjects were followed for a total of 235 patient years. Baseline characteristics (including duration of PSC and UC, medications, patient age, family history of colorectal cancer, and smoking status) were similar for both the groups. Patients who received high-dose UDCA had a significantly higher risk of developing colorectal neoplasia (dysplasia and cancer) during the study compared with those who received placebo (hazard ratio: 4.44, 95% confidence interval: 1.30-20.10, P=0.02).
CONCLUSIONS: Long-term use of high-dose UDCA is associated with an increased risk of colorectal neoplasia in patients with UC and PSC.
John E Eaton; Marina G Silveira; Darrell S Pardi; Emmanouil Sinakos; Kris V Kowdley; Velimir A C Luketic; M Edwyn Harrison; Timothy McCashland; Alex S Befeler; Denise Harnois; Roberta Jorgensen; Jan Petz; Keith D Lindor
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2011-05-10
Journal Detail:
Title:  The American journal of gastroenterology     Volume:  106     ISSN:  1572-0241     ISO Abbreviation:  Am. J. Gastroenterol.     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-09-07     Completed Date:  2011-10-31     Revised Date:  2013-06-30    
Medline Journal Info:
Nlm Unique ID:  0421030     Medline TA:  Am J Gastroenterol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1638-45     Citation Subset:  IM    
Department of Internal Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota 55905, USA.
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MeSH Terms
Chenodeoxycholic Acid / blood
Cholagogues and Choleretics / administration & dosage,  adverse effects*,  therapeutic use
Cholangitis, Sclerosing / complications,  drug therapy*
Colitis, Ulcerative / complications,  drug therapy*
Colorectal Neoplasms / blood,  chemically induced*,  complications,  pathology
Follow-Up Studies
Lithocholic Acid / blood
Middle Aged
Proportional Hazards Models
Retrospective Studies
Ursodeoxycholic Acid / administration & dosage,  adverse effects*,  therapeutic use
Young Adult
Grant Support
Reg. No./Substance:
0/Cholagogues and Choleretics; 128-13-2/Ursodeoxycholic Acid; 434-13-9/Lithocholic Acid; 474-25-9/Chenodeoxycholic Acid
Comment In:
Nat Rev Gastroenterol Hepatol. 2011 Jul;8(7):361   [PMID:  21725347 ]
Gastroenterology. 2011 Dec;141(6):2267-8   [PMID:  22027683 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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