INTRODUCTION

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Gallstone disease is still the most prevalent medical issue in the pancreatobiliary system.1,2 With the increase in the use of ultrasonography for screening purposes and evaluation of abdominal pain, gallstones are more frequently being detected. According to a study that looked into the demographic features of gallstone disease in Korea over the past 30 years, the total number of surgically treated gallstone patients rose three-folds during the study period.1 This increase was mostly attributable to the increase in the number of patients with gallbladder (GB) stones, which in turn can largely be ascribed to westernization of lifestyle and increase in body mass index (BMI), especially among the young patients.1,3 In fact, a study by Kim et al.4 showed that the prevalence of cholesterol gallstones in Korea proportionately increased as age decreased among those who underwent cholecystectomy (35.6% in patients aged ≥50 years vs 72.0% in patients aged <50 years).

Treatment of gallstone differs depending on the presence of symptoms, type of gallstone, and its location. Although laparoscopic cholecystectomy is the treatment of choice for symptomatic or complicated GB stones, oral litholysis with bile acids is an attractive alternative therapeutic option for asymptomatic or mildly symptomatic subgroups.2 Currently, the most widely used agents for oral litholysis in Korea are ursodeoxycholic acid (UDCA) alone or in combination with chenodeoxycholic acid (CDCA). The standard dose of UDCA prescribed for gallstone dissolution is 8 to 12 mg/kg/day.5 Dissolution therapy is recommended to be stopped after 6 months if the gallstones do not show any response, i.e., decrease in size. Dissolution therapy can be continued if gallstones are partially dissolved after 6 months, but should be stopped if complete dissolution is not achieved by 2 years. Complete dissolution rate varies among studies which ranges from 20% to 70%.6 A meta-analysis on dissolution therapy showed that complete dissolution occurred in 38% of patients when UDCA was given in doses greater than 7 mg/kg/day for more than 6 months.7 UDCA is generally well tolerated and does not cause any significant adverse effects although there have been reports on the acquisition of gallstone calcification during therapy.8-10 As for the combination therapy with UDCA and CDCA, the dose used for gallstone dissolution is 5 mg/kg/day each or 6 mg/kg/day each.5,10,11 The recommended duration of therapy is same as that of UDCA alone. Previous studies have shown that complete dissolution occurred in about 30% to 50% after 2 years of therapy,5,10 and that the mean dissolution rate at 6 months and 12 months were 44% to 82% and 53% to 100%, respectively.5,11 Compared to UDCA alone, diarrhea occurred more frequently in those treated with combination of UDCA and CDCA. These aforementioned previous studies have been conducted with the Western population,5,10,11 but data on its efficacy in non-Western population are lacking. Therefore, this phase 4, prospective, open-label, noncomparative, multicenter study was conducted to evaluate the gallstone dissolution efficacy and improvement of gallstone-related symptoms in Korean population.

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