High-dose ursodeoxycholic acid is associated with the development of colorectal neoplasia in patients with ulcerative colitis and primary sclerosing cholangitis

John E. Eaton, Marina G. Silveira, Darrell S. Pardi, Emmanouil Sinakos, Kris V. Kowdley, Velimir A C Luketic, M. Edwyn Harrison, Timothy M McCashland, Alex S. Befeler, Denise Harnois, Roberta Jorgensen, Jan Petz, Keith D. Lindor

Research output: Contribution to journalReview article

156 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1638-1645
Number of pages8
JournalAmerican Journal of Gastroenterology
Volume106
Issue number9
DOIs
StatePublished - Sep 1 2011

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Ursodeoxycholic Acid
Sclerosing Cholangitis
Ulcerative Colitis
Neoplasms
Colorectal Neoplasms
Placebos
Colonoscopy
Randomized Controlled Trials
Smoking
Confidence Intervals
Pathology

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

High-dose ursodeoxycholic acid is associated with the development of colorectal neoplasia in patients with ulcerative colitis and primary sclerosing cholangitis. / Eaton, John E.; Silveira, Marina G.; Pardi, Darrell S.; Sinakos, Emmanouil; Kowdley, Kris V.; Luketic, Velimir A C; Harrison, M. Edwyn; McCashland, Timothy M; Befeler, Alex S.; Harnois, Denise; Jorgensen, Roberta; Petz, Jan; Lindor, Keith D.

In: American Journal of Gastroenterology, Vol. 106, No. 9, 01.09.2011, p. 1638-1645.

Research output: Contribution to journalReview article

Eaton, JE, Silveira, MG, Pardi, DS, Sinakos, E, Kowdley, KV, Luketic, VAC, Harrison, ME, McCashland, TM, Befeler, AS, Harnois, D, Jorgensen, R, Petz, J & Lindor, KD 2011, 'High-dose ursodeoxycholic acid is associated with the development of colorectal neoplasia in patients with ulcerative colitis and primary sclerosing cholangitis', American Journal of Gastroenterology, vol. 106, no. 9, pp. 1638-1645. https://doi.org/10.1038/ajg.2011.156
Eaton, John E. ; Silveira, Marina G. ; Pardi, Darrell S. ; Sinakos, Emmanouil ; Kowdley, Kris V. ; Luketic, Velimir A C ; Harrison, M. Edwyn ; McCashland, Timothy M ; Befeler, Alex S. ; Harnois, Denise ; Jorgensen, Roberta ; Petz, Jan ; Lindor, Keith D. / High-dose ursodeoxycholic acid is associated with the development of colorectal neoplasia in patients with ulcerative colitis and primary sclerosing cholangitis. In: American Journal of Gastroenterology. 2011 ; Vol. 106, No. 9. pp. 1638-1645.
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abstract = "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.",
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AU - Eaton, John E.

AU - Silveira, Marina G.

AU - Pardi, Darrell S.

AU - Sinakos, Emmanouil

AU - Kowdley, Kris V.

AU - Luketic, Velimir A C

AU - Harrison, M. Edwyn

AU - McCashland, Timothy M

AU - Befeler, Alex S.

AU - Harnois, Denise

AU - Jorgensen, Roberta

AU - Petz, Jan

AU - Lindor, Keith D.

PY - 2011/9/1

Y1 - 2011/9/1

N2 - 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.

AB - 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.

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