Ursodiol

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Jeffrey C Oramsmith - One of the best experts on this subject based on the ideXlab platform.

  • a multicenter placebo controlled randomized double blind prospective trial of prophylactic Ursodiol for the prevention of gallstone formation following gastric bypass induced rapid weight loss
    1995
    Co-Authors: Harvey J Sugerman, William H Brewer, Mitchell L Shiffman, Robert E Brolin, Mathias A L Fobi, John H Linner, Kenneth G Macdonald, Alex M Macgregor, Louis F Martin, Jeffrey C Oramsmith
    Abstract:

    BACKGROUND: Previous studies have documented a high incidence of gallstone formation following gastric-bypass (GBP)-induced rapid weight loss in morbidly obese patients. This study was designed to determine if a 6-month regimen of prophylactic Ursodiol might prevent the development of gallstones. METHODS: A multicenter, randomized, double-blind, prospective trial evaluated 3 oral doses of Ursodiol: 300, 600, and 1,200 mg versus placebo beginning within 10 days after surgery and continuing for 6 months or until gallstone development, for patients with a body mass index (BMI) > or = 40 kg/m2. All patients had normal intraoperative gallbladder sonography. Transabdominal sonography was obtained at 2, 4, and 6 months following surgery, or until gallstone formation. RESULTS: Of 233 patients with at least one postoperative sonogram, 56 were randomized to placebo, 53 to 300 mg Ursodiol, 61 to 600 mg Ursodiol, and 63 to 1,200 mg Ursodiol. Preoperative age, sex, race, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation occurred at 6 months in 32%, 13%, 2%, and 6% of the patients on the respective doses. Gallstones were significantly (P < 0.001) less frequent with Ursodiol 600 and 1,200 mg than with placebo. CONCLUSION: A daily dose of 600 mg Ursodiol is effective prophylaxis for gallstone formation following GBP-induced rapid weight loss.

  • a multicenter placebo controlled randomized double blind prospective trial of prophylactic Ursodiol for the prevention of gallstone formation following gastric bypass induced rapid weight loss
    1995
    Co-Authors: Harvey J Sugerman, William H Brewer, Mitchell L Shiffman, Robert E Brolin, Mathias A L Fobi, John H Linner, Kenneth G Macdonald, Alex M Macgregor, Louis F Martin, Jeffrey C Oramsmith
    Abstract:

    Background Previous studies have documented a high incidence of gallstone formation following gastric-bypass (GBP)-induced rapid weight loss in morbidly obese patients. This study was designed to determine if a 6-month regimen of prophylactic Ursodiol might prevent the development of gallstones. Methods A multicenter, randomized, doubleblind, prospective trial evaluated 3 oral doses of Ursodiol: 300, 600, and 1,200 mg versus placebo beginning within 10 days after surgery and continuing for 6 months or until gallstone development, for patients with a body mass index (BMI) ≥40 kg/m2. All patients had normal intraoperative gallbladder sonography. Transabdominal sonography was obtained at 2, 4, and 6 months following surgery, or until gallstone formation. Results Of 233 patients with at least one postoperative sonogram, 56 were randomized to placebo, 53 to 300 mg Ursodiol, 61 to 600 mg Ursodiol, and 63 to 1,200 mg Ursodiol. Preoperative age, sex, race, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation occurred at 6 months in 32%, 13%, 2%, and 6% of the patients on the respective doses. Gallstones were significantly (P Conclusion A daily dose of 600 mg Ursodiol is effective prophylaxis for gallstone formation following GBP-induced rapid weight loss.

R Poupon - One of the best experts on this subject based on the ideXlab platform.

  • primary biliary cirrhosis incidence and predictive factors of cirrhosis development in Ursodiol treated patients
    2002
    Co-Authors: Christophe Corpechot, R Poupon, Fabrice Carrat
    Abstract:

    Abstract Background & Aims: Ursodeoxycholic acid (UDCA) slows the progression of primary biliary cirrhosis (PBC). However, some UDCA-treated patients escape and progress toward cirrhosis and end-stage disease. This study aimed to assess the incidence of cirrhosis in UDCA-treated patients with PBC and to determine the predictive factors of cirrhosis development under this treatment. Methods: A Markov model was used to describe the progression toward cirrhosis in 183 UDCA-treated patients with PBC. A total of 254 pairs of liver biopsy specimens collected during 655 patient-years were studied. Results: The incidence of cirrhosis after 5 years of UDCA treatment was 4%, 12%, and 59% among patients followed-up from stages I, II, and III, respectively. At 10 years, the incidence was 17%, 27%, and 76%, respectively. The median time for developing cirrhosis from stages I, II, and III was 25 years, 20 years, and 4 years, respectively. The independent predictive factors of cirrhosis development were serum bilirubin greater than 17 μmol/L, serum albumin less than 38 g/L, and moderate to severe lymphocytic piecemeal necrosis. Conclusions: This study provides new data about the time course of PBC under UDCA and constitutes a rationale for the design and evaluation of clinical trials aimed to assess the efficacy of drugs associated with UDCA. GASTROENTEROLOGY 2002;122:652-658

  • Ursodiol for the long term treatment of primary biliary cirrhosis
    1994
    Co-Authors: R Poupon, Beverley Balkau
    Abstract:

    Background Ursodiol (ursodeoxycholic acid) therapy leads to major improvements in patients with primary biliary cirrhosis. The benefit of long-term treatment is uncertain. Methods We randomly assigned 145 patients with biopsy-proved primary biliary cirrhosis to receive Ursodiol (13 to 15 mg per kilogram of body weight per day) (72 patients) or placebo (73 patients). After two years of follow-up, because of the benefit from Ursodiol, all patients completing the study received Ursodiol in an open trial and were monitored for two more years. The end points in the assessment of efficacy were as follows: progression of disease, as defined by the presence of hyperbilirubinemia, variceal bleeding, ascites, or encephalopathy; liver transplantation or a referral for that procedure; and liver transplantation (or a referral) or death. Results Disease progressed significantly less frequently in the Ursodiol group than in the placebo group (P<0.002; relative risk, 0.28; 95 percent confidence interval, 0.12 to 0.63). T...

  • Ursodiol for the long term treatment of primary biliary cirrhosis the udca pbc study group
    1994
    Co-Authors: R Poupon, Beverley Balkau
    Abstract:

    Background Ursodiol (ursodeoxycholic acid) therapy leads to major improvements in patients with primary biliary cirrhosis. The benefit of long-term treatment is uncertain. Methods We randomly assigned 145 patients with biopsy-proved primary biliary cirrhosis to receive Ursodiol (13 to 15 mg per kilogram of body weight per day) (72 patients) or placebo (73 patients). After two years of follow-up, because of the benefit from Ursodiol, all patients completing the study received Ursodiol in an open trial and were monitored for two more years. The end points in the assessment of efficacy were as follows: progression of disease, as defined by the presence of hyperbilirubinemia, variceal bleeding, ascites, or encephalopathy; liver transplantation or a referral for that procedure; and liver transplantation (or a referral) or death. Results Disease progressed significantly less frequently in the Ursodiol group than in the placebo group (P<0.002; relative risk, 0.28; 95 percent confidence interval, 0.12 to 0.63). T...

  • a multicenter controlled trial of Ursodiol for the treatment of primary biliary cirrhosis
    1991
    Co-Authors: E Eschwege, Beverley Balkau, R Poupon
    Abstract:

    Abstract Background. In primary biliary cirrhosis the hepatic lesions may result, at least in part, from the intracellular accumulation of potentially toxic endogenous bile acids. Preliminary work suggests that the administration of Ursodiol (also called ursodeoxycholic acid), a hydrophilic bile acid without hepatotoxicity, leads to improvement in the condition of patients with primary biliary cirrhosis. Methods. We conducted a two-year, multicenter, double-blind trial to compare the efficacy of Ursodiol with that of placebo. Patients with biopsy-proved primary biliary cirrhosis were randomly assigned to receive either Ursodiol (13 to 15 mg per kilogram of body weight per day) (n = 73) or placebo (n = 73). Treatment failure was defined as a doubling of bilirubin levels to more than 70 μmol per liter or the occurrence of a severe complication (ascites or variceal bleeding) or an adverse reaction. Results. Treatment failed in 6 patients in the Ursodiol group, as compared with 13 in the placebo group (P<0.01...

Harvey J Sugerman - One of the best experts on this subject based on the ideXlab platform.

  • a multicenter placebo controlled randomized double blind prospective trial of prophylactic Ursodiol for the prevention of gallstone formation following gastric bypass induced rapid weight loss
    1995
    Co-Authors: Harvey J Sugerman, William H Brewer, Mitchell L Shiffman, Robert E Brolin, Mathias A L Fobi, John H Linner, Kenneth G Macdonald, Alex M Macgregor, Louis F Martin, Jeffrey C Oramsmith
    Abstract:

    BACKGROUND: Previous studies have documented a high incidence of gallstone formation following gastric-bypass (GBP)-induced rapid weight loss in morbidly obese patients. This study was designed to determine if a 6-month regimen of prophylactic Ursodiol might prevent the development of gallstones. METHODS: A multicenter, randomized, double-blind, prospective trial evaluated 3 oral doses of Ursodiol: 300, 600, and 1,200 mg versus placebo beginning within 10 days after surgery and continuing for 6 months or until gallstone development, for patients with a body mass index (BMI) > or = 40 kg/m2. All patients had normal intraoperative gallbladder sonography. Transabdominal sonography was obtained at 2, 4, and 6 months following surgery, or until gallstone formation. RESULTS: Of 233 patients with at least one postoperative sonogram, 56 were randomized to placebo, 53 to 300 mg Ursodiol, 61 to 600 mg Ursodiol, and 63 to 1,200 mg Ursodiol. Preoperative age, sex, race, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation occurred at 6 months in 32%, 13%, 2%, and 6% of the patients on the respective doses. Gallstones were significantly (P < 0.001) less frequent with Ursodiol 600 and 1,200 mg than with placebo. CONCLUSION: A daily dose of 600 mg Ursodiol is effective prophylaxis for gallstone formation following GBP-induced rapid weight loss.

  • a multicenter placebo controlled randomized double blind prospective trial of prophylactic Ursodiol for the prevention of gallstone formation following gastric bypass induced rapid weight loss
    1995
    Co-Authors: Harvey J Sugerman, William H Brewer, Mitchell L Shiffman, Robert E Brolin, Mathias A L Fobi, John H Linner, Kenneth G Macdonald, Alex M Macgregor, Louis F Martin, Jeffrey C Oramsmith
    Abstract:

    Background Previous studies have documented a high incidence of gallstone formation following gastric-bypass (GBP)-induced rapid weight loss in morbidly obese patients. This study was designed to determine if a 6-month regimen of prophylactic Ursodiol might prevent the development of gallstones. Methods A multicenter, randomized, doubleblind, prospective trial evaluated 3 oral doses of Ursodiol: 300, 600, and 1,200 mg versus placebo beginning within 10 days after surgery and continuing for 6 months or until gallstone development, for patients with a body mass index (BMI) ≥40 kg/m2. All patients had normal intraoperative gallbladder sonography. Transabdominal sonography was obtained at 2, 4, and 6 months following surgery, or until gallstone formation. Results Of 233 patients with at least one postoperative sonogram, 56 were randomized to placebo, 53 to 300 mg Ursodiol, 61 to 600 mg Ursodiol, and 63 to 1,200 mg Ursodiol. Preoperative age, sex, race, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation occurred at 6 months in 32%, 13%, 2%, and 6% of the patients on the respective doses. Gallstones were significantly (P Conclusion A daily dose of 600 mg Ursodiol is effective prophylaxis for gallstone formation following GBP-induced rapid weight loss.

James M Thompson - One of the best experts on this subject based on the ideXlab platform.

  • Ursodiol Prophylaxis against Hepatic Complications of Allogeneic
    2016
    Co-Authors: Bone Marrow Transplantation, Jeffrey P Allerton, James M Thompson
    Abstract:

    Background: Hepatic complications are a major cause of illness and death after bone marrow transplantation. Objective: To confirm the results of a pilot study that indicated that Ursodiol prophylaxis could reduce the inci-dence of veno-occlusive disease of the liver. Design: Randomized, double-blind, placebo-controlled study

  • Ursodiol prophylaxis against hepatic complications of allogeneic bone marrow transplantation
    1998
    Co-Authors: James Essell, Glenn S Harman, Ronald Halvorson, Natalie S Callander, Mark T Schroeder, Vernon Lew, Michael Snyder, Stacey K Lewis, Jeffrey P Allerton, James M Thompson
    Abstract:

    Background: Hepatic complications are a major cause of illness and death after bone marrow transplantation. Objective: To confirm the results of a pilot study that indicated that Ursodiol prophylax...

  • Ursodiol prophylaxis against hepatic complications of allogeneic bone marrow transplantation a randomized double blind placebo controlled trial
    1998
    Co-Authors: James H Essell, Glenn S Harman, Ronald Halvorson, Natalie S Callander, Mark T Schroeder, Vernon Lew, Michael Snyder, Stacey K Lewis, Jeffrey P Allerton, James M Thompson
    Abstract:

    Background Hepatic complications are a major cause of illness and death after bone marrow transplantation. Objective To confirm the results of a pilot study that indicated that Ursodiol prophylaxis could reduce the incidence of veno-occlusive disease of the liver. Design Randomized, double-blind, placebo-controlled study. Setting Tertiary care teaching hospital. Patients 67 consecutive patients undergoing transplantation with allogeneic bone marrow (donated by a relative) in whom busulfan plus cyclophosphamide was used as the preparative regimen and cyclosporine plus methotrexate was used to prevent graft-versus-host disease. Intervention Before the preparative regimen was started, patients were randomly assigned to receive Ursodiol, 300 mg twice daily (or 300 mg in the morning and 600 mg in the evening if body weight was > 90 kg), or placebo. Measurements Patients were prospectively evaluated for the clinical diagnosis of veno-occlusive disease, the occurrence of acute graft-versus-host disease, and survival. Results The incidence of veno-occlusive disease was 40% (13 of 32 patients) in placebo recipients and 15% (5 of 34 patients) in Ursodiol recipients (P = 0.03). Assignment to placebo was the only pretransplantation characteristic that predicted the development of veno-occlusive disease. The most significant predictor of 100-day mortality was the diagnosis of veno-occlusive disease. The difference in actuarial risk for hematologic relapse in patients with chronic myelogenous leukemia and nonhepatic toxicities between the two groups was not statistically significant (13% in the Ursodiol group and 20% in the placebo group; P > 0.2). Conclusion Ursodiol prophylaxis seemed to decrease the incidence of hepatic complications after allogeneic bone marrow transplantation in patients who received a preparative regimen with busulfan plus cyclophosphamide.

  • pilot trial of prophylactic Ursodiol to decrease the incidence of veno occlusive disease of the liver in allogeneic bone marrow transplant patients
    1992
    Co-Authors: James H Essell, James M Thompson, Glenn S Harman, Ronald Halvorson, M J Snyder, Natalie S Callander, D J Clement
    Abstract:

    Ursodiol is a hydrophilic, non-hepatotoxic bile salt indicated for the medical treatment of cholesterol gallstones. This pilot study explored the use of prophylactic Ursodiol in an attempt to decrease the incidence and severity of veno-occlusive disease (VOD) of the liver following allogeneic bone marrow transplantation (BMT). Between February 1991 and January 1992, 22 consecutive patients undergoing BMT for hematologic malignancies received the BU(4)/CY(2) preparative regimen and CSA/MTX for GVHD prophylaxis. Ursodiol, 600-900 mg daily by mouth was begun at least 1 day prior to beginning the preparative regimen. Results for this pilot group were compared to a control group of 28 consecutive patients transplanted between June 1989 and January 1991 with the same regimen without Ursodiol. There were no significant differences in disease or clinical status between the groups pretransplant. However, mean baseline AST levels were significantly higher in the Ursodiol group, 28.0 U/l vs 18.1 U/l in the control group (p = 0.001). The median maximum bilirubin observed post-transplant was 2.35 mg/dl (range 0.9-45) in the Ursodiol group, and 5.05 mg/dl (range 0.7-29.4) in controls. The incidence of VOD was 2/22 (9.1%) in the Ursodiol group and 18/28 (64.3%) in controls (p = 0.0001). Death due to VOD occurred in 1/22 patients (4.5%) in the Ursodiol group and in 6/28 (21.4%) controls (p = 0.12). Our data suggest that Ursodiol may decrease the incidence of VOD in allogeneic BMT patients.

Kenneth G Macdonald - One of the best experts on this subject based on the ideXlab platform.

  • a multicenter placebo controlled randomized double blind prospective trial of prophylactic Ursodiol for the prevention of gallstone formation following gastric bypass induced rapid weight loss
    1995
    Co-Authors: Harvey J Sugerman, William H Brewer, Mitchell L Shiffman, Robert E Brolin, Mathias A L Fobi, John H Linner, Kenneth G Macdonald, Alex M Macgregor, Louis F Martin, Jeffrey C Oramsmith
    Abstract:

    BACKGROUND: Previous studies have documented a high incidence of gallstone formation following gastric-bypass (GBP)-induced rapid weight loss in morbidly obese patients. This study was designed to determine if a 6-month regimen of prophylactic Ursodiol might prevent the development of gallstones. METHODS: A multicenter, randomized, double-blind, prospective trial evaluated 3 oral doses of Ursodiol: 300, 600, and 1,200 mg versus placebo beginning within 10 days after surgery and continuing for 6 months or until gallstone development, for patients with a body mass index (BMI) > or = 40 kg/m2. All patients had normal intraoperative gallbladder sonography. Transabdominal sonography was obtained at 2, 4, and 6 months following surgery, or until gallstone formation. RESULTS: Of 233 patients with at least one postoperative sonogram, 56 were randomized to placebo, 53 to 300 mg Ursodiol, 61 to 600 mg Ursodiol, and 63 to 1,200 mg Ursodiol. Preoperative age, sex, race, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation occurred at 6 months in 32%, 13%, 2%, and 6% of the patients on the respective doses. Gallstones were significantly (P < 0.001) less frequent with Ursodiol 600 and 1,200 mg than with placebo. CONCLUSION: A daily dose of 600 mg Ursodiol is effective prophylaxis for gallstone formation following GBP-induced rapid weight loss.

  • a multicenter placebo controlled randomized double blind prospective trial of prophylactic Ursodiol for the prevention of gallstone formation following gastric bypass induced rapid weight loss
    1995
    Co-Authors: Harvey J Sugerman, William H Brewer, Mitchell L Shiffman, Robert E Brolin, Mathias A L Fobi, John H Linner, Kenneth G Macdonald, Alex M Macgregor, Louis F Martin, Jeffrey C Oramsmith
    Abstract:

    Background Previous studies have documented a high incidence of gallstone formation following gastric-bypass (GBP)-induced rapid weight loss in morbidly obese patients. This study was designed to determine if a 6-month regimen of prophylactic Ursodiol might prevent the development of gallstones. Methods A multicenter, randomized, doubleblind, prospective trial evaluated 3 oral doses of Ursodiol: 300, 600, and 1,200 mg versus placebo beginning within 10 days after surgery and continuing for 6 months or until gallstone development, for patients with a body mass index (BMI) ≥40 kg/m2. All patients had normal intraoperative gallbladder sonography. Transabdominal sonography was obtained at 2, 4, and 6 months following surgery, or until gallstone formation. Results Of 233 patients with at least one postoperative sonogram, 56 were randomized to placebo, 53 to 300 mg Ursodiol, 61 to 600 mg Ursodiol, and 63 to 1,200 mg Ursodiol. Preoperative age, sex, race, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation occurred at 6 months in 32%, 13%, 2%, and 6% of the patients on the respective doses. Gallstones were significantly (P Conclusion A daily dose of 600 mg Ursodiol is effective prophylaxis for gallstone formation following GBP-induced rapid weight loss.

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