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| |  First-Ever Gallstone Prevention Medication Now Available EAST HANOVER, N.J., May 7, 1997 -- Actigall(R) (ursodiol - USP), a new drug for the prevention of gallstones in obese patients experiencing rapid weight loss, is now available. Cleared for marketing by the FDA for this purpose, Actigall is the first medication indicated for the prevention of gallstones in these patients. It has been used to dissolve certain types of gallstones in appropriately selected patients since 1988. Actigall was developed by Novartis Pharmaceuticals Corporation. "Actigall gives obese people undergoing rapid weight loss, a population at high risk for gallstones, a safe and effective preventive option," says Mitchell L. Shiffman, M.D., hepatologist, Medical College of Virginia Hospitals. "With this medication, obese people losing weight quickly may avoid the sometimes painful symptoms caused by gallstones and the surgery that may be needed to remove them." Gallstones are one of the most significant complications of voluntary rapid weight loss. For most people, gallstones are asymptomatic or silent and can be safely left alone. While it is unclear what percentage of people with silent gallstones will develop symptomatic gallstones, they can be very painful and can lead to a variety of potentially serious symptoms and problems. According to the National Institutes of Health, gallstones from all causes result in 600,000 hospitalizations and more than 500,000 operations each year. Gallstone Formation While there is no strict definition of "rapid weight loss," the potential for gallstone formation increases dramatically when weight loss exceeds an average of about 10-12 lbs. a month. Two techniques for rapid weight loss that make dieters particularly prone to gallstone formation include very low calorie diets (VLCDs), which provide 800 calories a day or less for 12 to 16 weeks, and gastric bypass surgery, which reduces the size of the stomach to prevent overeating. Additionally, gallstones may form with other types of rapid weight loss programs. How Actigall Works Gallstones are clusters of solid material, mostly cholesterol, that form in the gallbladder. Actigall works by suppressing the secretion of cholesterol and inhibiting intestinal absorption of cholesterol. By increasing the level at which cholesterol saturation occurs, Actigall helps prevent the formation of gallstones. Actigall is a naturally occurring acid found in small quantities in normal human bile and in larger quantities in the bile of the polar bear. To prevent gallstones in obese patients, a 300 mg capsule of Actigall is taken twice daily during the period of rapid weight loss which is usually four months for patients on VLCDs, and six months for gastric bypass patients. Clinical Trial Data Two placebo-controlled, multicenter, double-blind, randomized, parallel group trials of 1,316 obese patients undergoing rapid weight loss were undertaken to evaluate the effectiveness of Actigall in preventing gallstones. In the first trial, 1,004 obese patients lost weight through VLCDs for a period of 16 weeks. Gallstones occurred in 23 percent of the placebo group, while those on the recommended dose of 600 mg/day of Actigall experienced a 3 percent incidence of gallstone formation. The second trial looked at 312 obese patients who lost weight through gastric bypass surgery. Gallstone formation occurred in 23 percent of the placebo group, while patients taking 600 mg/day of Actigall experienced a 1 percent incidence of gallstone formation. The trial drug treatment period lasted six months after surgery. Side Effects Actigall may not be for everyone. Patients should check with their physician to find out if they are at risk of developing gallstones and to determine if Actigall is appropriate for them. Also, other medications may interact with Actigall. The most common side effects observed in trials with Actigall were constipation, diarrhea and headache. Indications Actigall has two indications: 1. New Indication - Actigall is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. Gallbladder stone dissolution with Actigall treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within five years has been observed in up to 50 percent of patients who do dissolve their stones on bile acid therapy. Patients should be carefully selected for therapy with ursodiol, and alternative therapies should be considered.
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