TitleUrsodeoxycholic Acid Can Prevent Bariatric Surgery-Related Gallstone Disease in Some Patients:
By Nancy Melville
VIRTUAL -- May 24, 2021 -- The use of prophylactic ursodeoxycholic acid (UDCA) in patients undergoing bariatric surgery is associated with a significant reduction in the risk of the development of gallstones, but only among patients with no evidence of gallstones at prior to surgery, according to a study presented at Digestive Disease Week (DDW) 2021.
“In patients without asymptomatic gallstones at baseline, UDCA prophylaxis for 6 months after bariatric surgery reduces symptomatic gallstone disease within 24 months,” said Sylke Haal, MD, Amsterdam UMC, Amsterdam, the Netherlands.
The UPGRADE trial was a multicentre double-blinded trial in which patients undergoing bariatric surgery with Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy were randomised 1:1 to either UDCA 900 mg/day (n = 477) for 6 months starting within 2 weeks after surgery or placebo (n = 490). Most (80%) patients were female, and the mean age was 45 years. The majority (91.9%) of patients received RYGB.
Ultrasound of the gallbladder that was performed prior to surgery showed that 19.5% of patients had asymptomatic gallstones.
For the primary endpoint in the modified intention-to-treat population, the percentage of patients in the UDCA arm that developed symptomatic gallstone disease within 24 months of surgery was 6.5% versus 9.7% in the placebo arm, which, though lower, was not a statistically significant difference (P = .073).
However, a subgroup analysis showed that among the subset of patients who did not have gallstones at baseline, 4.1% of the 381 patients in the UDCA arm had gallstone disease at 24 months versus 8.9% among the 392 patients in the placebo arm (P = .01). In patients without gallstones at baseline, 11% in the UDCA arm developed gallstones at 24 months versus 21% in the placebo group (P
“We did not see a beneficial effect of UDCA in patients with asymptomatic gallstones at baseline,” said Dr. Haal. “However, based on a number needed to treat of 21, we consider the administration of UDCA to be desirable among patients without gallstones at baseline.”
Digestive Disease Week is cosponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
[Presentation title: Ursodeoxycholic Acid for the Prevention of Symptomatic Gallstone Disease After Bariatric Surgery: a Multicenter, Randomized, Placebo-Controlled, Double-Blind Superiority Trial (Upgrade Trial). Abstract 355]