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 - 12/09/11

Doi : 10.1016/S0002-9610(99)80115-9

Harvey J. Sugerman, MD ^a,^⁎, William H. Brewer, MD ^b, Mitchell L. Shiffman, MD ^c, Robert E. Brolin, MD ^d, Mathias A.L. Fobi, MD ^e, John H. Linner, MD ^f, Kenneth G. MacDonald, MD ^g, Alex M. MacGregor, MD ^h, Louis F. Martin, MD ⁱ, Jeffrey C. Oram-Smith, MD ^j, Dapo Popoola, MD ^k, Bruce D. Schirmer, MD ^l, Florence F. Vickers, PhD ^m
^a From the Department of Surgery, Medical College of Virginia, Virginia Commonwealth University. Richmond. Virginia, USA
^b From the Department of Radiology, Medical College of Virginia, Virginia Commonwealth University. Richmond. Virginia, USA
^c From the Department of Medicine, Medical College of Virginia, Virginia Commonwealth University. Richmond. Virginia, USA
^d From the Robert Wood Johnson School of Medicine. New Brunswick, New Jersey, USA
^e Center for the Treatment of Obesity. Los Angeles, California, USA
^f From the Private Practice, Minneapolis. Minnesota, USA
^g From the East Carolina University, Greensville, North Carolina, USA
^h From the Private Practice, Gainesville, Florida, USA
ⁱ From the Pennsylvania State University Medical Center. Hershey. Pennsylvania, USA
^j From the Private Practice, Colorado Springs, Colorado, USA
^k From Private Practice, Los Angeles, California, USA
^l From the University of Virginia School of Medicine, Charlottesville. Virginia, USA
^m Ciba-Geigy Corporation. Summit, New Jersey, USA

^*Requests for reprints should be addressed to Harvey J. Sugerman, MD, David M. Hume Professor of Surgery, Box 980519, Medical College of Virginia, Virginia Commonwealth University, Richmond, Virginia 23298.

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 <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.

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***	This study was supported by grants from the Ciba-Geigy Corporation. Summit, New Jersey.

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Vol 169 - N° 1

P. 91-97 - janvier 1995 Retour au numéro

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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 - 12/09/11

Abstract

Background

Methods

Results

Conclusion

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