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Background: Morbidly obese patients enrolled in a rapid weight reduction program are at a high risk of developing gallstones. Two multicenter, placebo-controlled, randomized, double-blind trials have demonstrated that the prophylactic use of ursodiol in males and females 18 to 70 years of age is effective for the prevention of gallstone formation in this patient population. This study examines the cost consequences associated with the prophylactic use of ursodiol., Methods: A medical decision analysis model for the prophylactic administration of ursodiol in morbidly obese patients undergoing rapid weight reduction by either gastric bypass surgery or very-low-calorie-diet, was developed through the use of data from two clinical trials and review of the related literature. The expert opinion of clinicians from the fields of internal medicine, gastroenterology and surgery were solicited. Financial data for the charges associated with cholecystectomies, physician fees and ursodiol were obtained from current financial databases., Results: The model demonstrates that the prophylactic administration of ursodiol, in morbidly obese patients undergoing rapid weight reduction, results in cost savings. Sensitivity analysis was performed to illustrate that the cost savings achieved by the prophylactic use of ursodiol were valid over a realistic range of charges and assumptions., Conclusion: The decision model may allow health care decision makers to apply their own data to the model to determine the cost savings obtainable through the prophylactic use of ursodiol in patients undergoing rapid weight reduction.

Cholesterol gallbladder stones can be dissolved with chenodeoxycholic acid (CDCA) or ursodeoxycholic acid (UDCA). Response rate is 60-90%, dissolution rate 60% in stones not exceeding 1.5 cm in diameter. Mean treatment time amounts to 18 months. To improve oral litholysis: 1) UDCA was combined with the amino acid taurine, 2) CDCA and UDCA were administered in a single bedtime dose, 3) they were combined, each bile acid in half dosage, and 4) they were mixed with terpenes. Although there was some improvement with the combination therapy, final outcome is still suboptimal. Many investigations have been performed concerning gallbladder function, mucus production and nucleating factors, showing both that cholesterol supersaturation of bile is the conditio sine qua non for gallstone formation and that other factors play an additional, important role for the development of the first nidus. These factors have to be considered when therapy shall be improved. As yet oral litholysis has shown neither drug-related side effects nor lethality. It is not more expensive than surgery. Direct contact litholysis with methyl tert-butyl ether could reduce the indication for oral treatment to floating stones or patients who refuse gallbladder puncture. But although oral litholysis does not provide us with optimal results and needs further improvements, it will always keep its place in gallstone therapy.

Bedtime administration has been advocated as a strategy for reducing minimum effective dose, side effects, and costs of chenodeoxycholic acid treatment of cholesterol gallstones, but little information is available for ursodeoxycholic acid (UDCA). We prospectively determined the minimum effective dose of bedtime UDCA in 44 patients with radiolucent gallstones treated with a range of UDCA doses (4.6-17.0 mg/kg/day). The average minimum effective dose for reducing the cholesterol saturation index (SI) of gallbladder bile to a value of 0.8 was 8.4 mg/kg/day for bedtime UDCA. The greater potency of the bedtime regimen was confirmed in seven individual patients by comparison with a mealtime regimen. Cholesterol SI was reduced from 1.25 during placebo to 0.73 during 7 mg/kg/day for bedtime UDCA and to 0.81 during 10 mg/kg/day for mealtime UDCA. The effect of the bedtime regimen was not enhanced by a repeated-release tablet formulation of UDCA by comparison with UDCA in 15 patients. We conclude that the bile acid dose is reduced during bedtime UDCA administration by comparison with mealtime UDCA in individual patients and that the best-buy regimen is 8.4 mg/kg/day UDCA given at bedtime for patients with gallstones as a group. With this dose, gallstone dissolution can be supported by unsaturated gallbladder bile at minimum risk of dose-related side effects and at minimum treatment costs.

Objective: Ursodeoxycholic acid (ursodiol) is an oral dissolution agent recently approved by the Food and Drug Administration for treatment of cholelithiasis. The authors conducted a cost-effectiveness analysis comparing ursodiol with elective cholecystectomy and expectant management for men and women of ages 50 and 70 with typical chronic biliary symptoms., Design: Using published literature and national cost data, the authors performed a decision analysis in which the outcome measures were life expectancy, quality-adjusted life expectancy, and expected lifetime treatment cost., Patients: The analysis applies to patients with symptoms of biliary colic, noncalcified gallstones less than 20 mm in diameter, and functioning oral cholecystograms, who are candidates for elective cholecystectomy. Excluded were patients with acute cholecystitis or known or suspected common bile duct stones., Results: Ursodiol is both clinically advantageous and less expensive than surgery for symptomatic men aged 64 or more, and for symptomatic women aged 69 or more. At ages younger than these, the clinical advantage of surgery is small and could be nullified if ursodiol were targeted at patients for whom dissolution is most likely to be effective, based on evidence of stone size and composition. Expected lifetime costs of ursodiol range from $300-400 more than surgery for 50-year-olds to $700-1,000 less than surgery for 70-year-olds. Ursodiol is the preferred choice for patients throughout this age range who are at significantly elevated risk of operative mortality., Conclusion: Ursodiol is a clinically advantageous and cost-effective alternative to elective cholecystectomy, especially for older and high-risk patients.

Over 500,000 cholecystectomies are performed each year in the United States. The procedure has its risks (mortality is 1.2% in the general population and 3% in patients aged 75 years or over) and it is expensive: the average direct cost of each cholecystectomy is about $10,000, for a national total of $5 billion annually. An alternative to surgery is to dissolve the stone with ursodiol, a naturally occurring bile acid, which has been successfully used for cholesterol gallstones with a diameter less than 20 mm. A computer model was developed to compare the costs of surgery for gallstones and treatment with ursodiol. In a hypothetical health maintenance organization with one million enrollees, use of ursodiol treatment rather than cholecystectomy would result in cumulative savings of $8.5 million after one year, $30.7 million after five years, and $57.8 million after ten years.

Three therapeutic strategies are possible in a patient with asymptomatic or mildly symptomatic cholesterol gallstones: Cholecystectomy, medical gallstone dissolution, and expectant attitude. The course of cholelithiasis under these three strategies was evaluated by three decision trees. The incidences of possible complications were taken from the literature. For every complication the costs of drugs, absenteeism, treatment as outpatient and inpatient were listed. The costs multiplied by the likelihood of the complication represent the expected costs of the complication under consideration. The sum of the costs due to the initial treatment and the expected costs of all possible complications corresponds with the expected average costs of a therapeutic strategy. It is 21 000,- DM with medical gallstone dissolution, 25 000,- DM with immediate cholecystectomy, and 27 000,- DM with expectant attitude, respectively. Gallstone dissolution becomes more expensive than cholecystectomy only when its efficacy drops below 40%. The data show that the costs are less important for the choice of the therapy in cholelithiasis. The advantage of the decision tree lies in the fact that it describes the history and the costs of a disease by figures. Thereby, disagreement on the effects of a therapy on the course of the disease can be analysed and discussed more distinctly.