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    Home > Active Ingredient News > Digestive System Information > The Lancet Gastroenterology & Hepatology: Ursodeoxycholic acid can be used to prevent symptomatic gallstone disease after bariatric surgery

    The Lancet Gastroenterology & Hepatology: Ursodeoxycholic acid can be used to prevent symptomatic gallstone disease after bariatric surgery

    • Last Update: 2022-01-07
    • Source: Internet
    • Author: User
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    Ursodeoxycholic acid can dissolve gallstones, but this drug is only effective for cholesterol stones, and has no effect on melanin stones and bile pigment stones
    .
    In addition, rapid weight loss is the main risk factor for the formation of cholesterol gallstones

    .
    Therefore, morbidly obese patients undergoing bariatric surgery often suffer from symptomatic gallstone disease
    .
    This study aims to evaluate the efficacy of ursodeoxycholic acid compared with placebo in
    preventing symptomatic gallstone disease after bariatric surgery
    .

    Ursodeoxycholic acid can dissolve gallstones, but this drug is only effective for cholesterol stones, and has no effect on melanin stones and bile pigment stones
    .
    In addition, rapid weight loss is the main risk factor for the formation of cholesterol gallstones

    .
    Cholesterol prevention

     

    This is a multicenter, double-blind, randomized, placebo-controlled trial involving patients with intact gallbladder who plan to undergo laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy
    .
    Patients were randomly assigned (1:1) to receive 900 mg of ursodeoxycholic acid per day or a matching placebo through the network randomization module for 6 months of treatment

    .
    Random assignment is stratified based on the presence of asymptomatic gallstones at baseline and the type of surgery

    .
    Patients, clinicians, and researchers keep the treatment allocation confidential

    .
    The main endpoint is whether the patient has cholelithiasis within 24 months

    .
    In addition, safety assessments were performed on all patients who took at least one dose of the study drug

    .

     

    From January 11, 2017 to October 22, 2018, 985 patients were randomly assigned to receive ursodeoxycholic acid (n=492) or placebo (n=493)
    .
    967 patients were included in the revised intention-to-treat population, of which 959 had data available for the primary endpoint assessment

    .
    189 (20%) patients had asymptomatic gallstones at baseline, and 78 (8%) underwent sleeve gastrectomy

    .
    Of the 475 patients in the ursodeoxycholic acid group, 31 (6.
    5%) developed symptomatic gallstones, and of the 484 patients in the placebo group, 47 (9.
    7%) developed symptomatic Cholelithiasis (HR:0-67, 95% CI 0.
    43-1.
    04, P=0.
    071)

    .
    Logistic regression showed that there was a significant interaction between ursodeoxycholic acid and the presence of asymptomatic gallstones at baseline (p=0.
    046), and ursodeoxycholic acid had an effect on patients without gallstones (HR: 0.
    47, 95%) CI: 0.
    27-0.
    84, p=0.
    0081), but had no effect on patients with asymptomatic gallstones at baseline (HR: 1.
    22, 95% CI: 0.
    61-2.
    47, p=0.
    57)

    .
    In patients without gallstones at baseline, the effect of receiving RYGB was stronger (HR: 0.
    37, 95% CI: 0.
    20-0.
    71, p=0.
    0016), while the subgroup of patients who underwent sleeve gastrectomy was too small to draw A clear conclusion

    .
    Adverse events are rare

    .
    In the ursodeoxycholic acid group, 4 out of 444 patients (0.
    9%) had diarrhea, and 2 (0.
    5%) patients had a rash

    .
    In the placebo group, 2 out of 453 patients (0.
    4%) had diarrhea, and 2 (0.
    4%) patients had a rash

    .
    There was no significant difference in the total number of serious adverse events between the trial groups (75 out of 444 patients in the ursodeoxycholic acid group [17%] and 102 out of 453 patients in the placebo group [23%])

    .
    The most common serious adverse events were abdominal pain and internal hernia

    .

     

    This study confirmed that the prevention of ursodeoxycholic acid did not significantly reduce the incidence of symptomatic gallstone disease in all patients after bariatric surgery
    .
    In patients without gallstones before RYGB surgery, ursodeoxycholic acid treatment reduced the occurrence of symptomatic gallstone disease

    .
    However, further research is needed to evaluate the efficacy of ursodeoxycholic acid after sleeve gastrectomy

    .

    This study confirmed that the prevention of ursodeoxycholic acid did not significantly reduce the incidence of symptomatic gallstone disease in all patients after bariatric surgery
    .
    In patients without gallstones before RYGB surgery, ursodeoxycholic acid treatment reduced the occurrence of symptomatic gallstone disease

    .
    However, further research is needed to evaluate the efficacy of ursodeoxycholic acid after sleeve gastrectomy

    .

    Original source:

    SylkeHaal.
    Et al.
    Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery (UPGRADE): a multicentre, double-blind, randomised, placebo-controlled superiority trial.
    The Lancet Gastroenterology & Hepatology.
    2021.

    Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery (UPGRADE): a multicentre, double-blind, randomised, placebo-controlled superiority trial.


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