Phase III Trial of Ursodeoxycholic Acid To Prevent Colorectal Adenoma Recurrence

Abstract

UDCA treatment was associated with a non-statistically significant reduction in total colorectal adenoma recurrence but with a statistically significant 39% reduction in recurrence of adenomas with high-grade dysplasia. Because severely dysplastic lesions have a high risk of progression to invasive colorectal carcinoma, this finding indicates that future chemoprevention trials of UDCA in individuals with such lesions should be considered.

Association Between Body Size and Colorectal Adenoma Recurrence

“…The UDCA trial was a randomized, double-blind, placebo-controlled trial conducted to compare the effect of UDCA on adenoma recurrence among patients that had a prior polyp removed at colonoscopy 3 . A total of 1285 participants were randomized to either the treatment or placebo group, with 1192 participants (92.8%) completing the study 3 .…”

“…Among patients that have had colorectal adenomas, recognized predictors of subsequent lesions include age, adenoma size, histology and multiplicity of the lesions at detection 1 . Depending on the age of the population, between 20 and 50% of those patients with adenomas will recur within a 3-5 year period, with 10-20% of recurrent lesions possessing clinically advanced features (larger size, villous histology, and/or high-grade dysplasia) [2][3][4][5][6] . The current recommendation for patients presenting with small polyps (less than 1 cm) is to have a followup colonoscopy 5-10 years after the initial procedure 1 .…”

S3-Leitlinie – Kolorektales Karzinom

“…In einer Phase-III-Studie zur Sekundärprävention von Kolonadenomen senkte Ursodesoxycholsäure signifikant nur das Risiko für Adenome mit hochgradigen Dysplasien, aber nicht für Adenome insgesamt [90]. Prospektive Studien zur Primärprävention von Adenomen mittels Ursodesoxycholsäu-re liegen nicht vor.…”

Longer lifespan in male mice treated with a weakly estrogenic agonist, an antioxidant, an α‐glucosidase inhibitor or a Nrf2‐inducer

“…Amador‐Noguez et al ., 2007). Moreover, in a clinical trial UDCA prevented colorectal adenoma recurrence (Alberts et al ., 2005). UDCA treatment suppressed chemically induced diabetes in rats (Lukivskaya et al ., 2004).…”