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BILE ACID THERAPY IS SAFE AND EFFECTIVE FOR 15% OF GALLSTONE PATIENTS

Executive Summary

BILE ACID THERAPY IS SAFE AND EFFECTIVE FOR 15% OF GALLSTONE PATIENTS, a National Institutes of Health consensus panel report concludes. People for whom oral drug therapy is effective should have functioning gallbladders containing small floating cholesterol stones that are less than 5-10 mm in diameter, the conference's final draft report states. Dissolution rates are higher and gallstone recurrence rates are lower in patients who are non-obese or young and who have only a single gallstone, the report notes. The final draft report was presented at the conclusion of a three-day consensus conference, "Gallstones and Laparoscopic Cholecystectomy," held Sept. 14-16 on the NIH campus in Bethesda, Md. The primary focus of the conference was on surgical options for the removal of gallstones. The report notes that patients with gallstones greater than 10 mm have a 60% bile acid therapy dissolution rate compared to a 90% dissolution rate for patients with gallstones less than 5 mm in diameter. Bile acid therapy requires six to 12 months, after which, the report concludes, continued monitoring is needed because gallstones recur within five years of therapy in about half of the patients treated. However, the report notes, "data are insufficient to support the use of maintenance bile acid therapy after stone dissolution." The consensus conference panel also concluded that the chance of complete dissolution is poor in patients with larger and predominately non-cholesterol stones. The report notes further that it is not "known whether the addition of hydroxymethylglutaryl CoA (HMG-CoA) reductase inhibitors to bile acid therapy will contribute to the dissolution rate" or if the use of nonsteroidal anti-inflammatory drugs "will reduce recurrence rates." Ciba-Geigy's Actigall (ursodiol) and Solvay's Chenix (chenodiol) are the only oral bile acid agents approved by FDA for gallstone dissolution. Due to its adverse reaction profile, chenodiol's use has been "largely supplanted" by ursodiol, the draft report notes. The recommended dosing regimen of Actigall is 8 to 10 mg/kg per day given in two or three divided doses. In a presentation made during the conference, Leslie Schoenfield, MD/PhD, Cedars-Sinai Medical Center, said "the fundamental requirement for [bile acid therapy] is radiolucent gallstones in a gallbladder that is visualized by oral cholecystography." He added that "imaging surveys suggest that perhaps 20% of patients with gallstones are eligible" for drug therapy. Schoenfield, a gastroenterologist, described the "ideal candidate" for bile acid therapy as a "thin woman with small, floating gallstones." The conference report states that "the prevalence [of gallstones] is higher in women, in association with multiple pregnancies, obesity, and rapid weight loss, as well as in older patients and in certain ethnic groups." Bile acid therapy is not recommended for those patients. However, drug therapy also can be used in gallstone patients whose conditions preclude either a safe laparoscopic cholecystectomy or open cholecystectomy or who wish to avoid surgery altogether. The consensus conference's major conclusion was that the relatively new, minimally-invasive surgical procedure laparoscopic cholecystectomy is equally safe and effective as open abdominal surgery for symptomatic gallstone disease. About 500,000 gallstone patients undergo cholecystectomies annually, and approximately "10-15% of the adult population, or more than 20 mil. people in the U.S. have gallstones," the report states.
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