NEW YORK (Reuters Health) – Ursodeoxycholic acid for the prevention of gallstones after bariatric surgery is not universally helpful in all patients, new research suggests.
Taking the bile salt helps reduce the occurrence of gallstones in patients undergoing Roux-en-Y gastric bypass (RYGB) who do not have gallstones before the surgery but not in peers with asymptomatic gallstones at baseline. And the jury is out on the efficacy of ursodeoxycholic acid after sleeve gastrectomy.
The findings from the UPGRADE randomized controlled trial appear in The Lancet Gastroenterology & Hepatology.
Rapid surgical weight loss is a major risk factor for the formation of gallstones. Ursodeoxycholic acid reduces the formation of gallstones, but it remains unclear whether all patients should take it after bariatric surgery, the authors note in their paper.
The UPGRADE study enrolled 985 patients with an intact gallbladder undergoing RYGB or sleeve gastrectomy. Half were randomly assigned to ursodeoxycholic acid 900 mg daily and half to placebo for six months after surgery.
A total of 189 patients (20%) had asymptomatic gallstones at baseline. The primary outcome was symptomatic gallstones within 24 months.
In the overall analysis, ursodeoxycholic acid prophylaxis did not significantly reduce the occurrence of symptomatic gallstones after bariatric surgery compared with placebo; symptomatic gallstones occurred in 6.5% of the ursodeoxycholic acid group and 9.7% of the placebo group (relative risk, 0.67; P=0.071).
However, there was a significant interaction between treatment with the bile salt and the presence of asymptomatic gallstones at baseline.
In patients free of gallstones at baseline, ursodeoxycholic acid led to a “clinically relevant” reduction in the development of symptomatic gallstones (4.2% vs. 8.9%; RR, clomid for men 0.47; P=0.0081), with a number needed to treat (NNT) of 21 to avoid one patient from having symptomatic gallstones.
In patients with asymptomatic gallstones at baseline, ursodeoxycholic acid did not prevent them becoming symptomatic (16.0% vs. 13.0%; RR, 1.22; P=0.57).
The effect of ursodeoxycholic acid was stronger in patients without gallstones at baseline undergoing RYGB (3.4% vs. 9.2%; RR, 0.37; P=0.0016), with an NNT of 17.
The subgroup of patients undergoing sleeve gastrectomy was too small to draw clear conclusions on the benefits of ursodeoxycholic acid.
“Based on these findings, we consider the use of ursodeoxycholic acid desirable in patients who do not have gallstones before undergoing RYGB. As a consequence, routine preoperative gallbladder ultrasonography should be done to determine the absence of gallstones,” write Dr. Rogier Voermans with Amsterdam University Medical Center and colleagues.
The U.K.-based authors of a linked comment say the UPGRADE study results are germane to clinical practice for bariatric multidisciplinary teams.
“Multidisciplinary teams place a great deal of emphasis on educating patients to take the requisite vitamin and mineral supplements postoperatively, and having the appropriate monitoring, to avoid the certainty of long-term deficiencies,” Dr. Richard Welbourn with Musgrove Park Hospital in Taunton and Dr. Dimitri Pournaras with Southmead Hospital in Bristol point out.
“Multidisciplinary teams will now need to educate patients additionally that taking ursodeoxycholic acid further reduces the already low risk of gallstones. As many patients have difficulty swallowing tablets in the first few weeks after bariatric surgery, they will need to be persuaded of the benefits of consuming another sizeable tablet together with their other supplements,” they say.
“Notably, despite a highly motivated research team, less than two-thirds of the randomly assigned patients in the study were regarded as compliant with taking ursodeoxycholic acid or the placebo,” they point out.
Zambon Netherlands BV hekped fund the study and provided trial materials consisting of all ursodeoxycholic acid tablets and an ultrasonography device.
SOURCE: https://bit.ly/3By2mfq and https://bit.ly/3bv73vJ Lancet Gastroenterology & Hepatology, online October 26, 2021.
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