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Studies suggest promising new directions for gallstone treatment

owned by the pharmaceutical company GlaxoSmithKline.

Mangelsdorf said the compound's effects were dramatic. "Their cholesterol saturation, bile lipids, and bile hydrophobicity were normal. And they showed no cholesterol crystal precipitation or inflammation," he said. In contrast, susceptible mice that did not receive GW4064 showed evidence of gallstone formation. Mangelsdorf said the studies also showed that FXR-knockout mice in which the drug was not expected to work developed CGD more rapidly than the susceptible mice.

"While we have not shown in this study that the drug that activates FXR cures the disease once it starts, it does prevent gallstones from occurring," said Mangelsdorf. Although further studies will be needed to determine whether the FXR-activating drug could dissolve gallstones, their findings have clinical implications for both diagnosis and prevention of CGD, he said.

"Humans are known to have a genetic component to risk of CGD that has never been identified," he said. "While surgical removal of the gallbladder will remain the major treatment for existing CGD, if we can identify those at genetic risk, we might be able to prevent the disease. The lack of FXR might well be a diagnostic marker for genetic predisposition to CGD."

Also promising, said Mangelsdorf, is the potential for such a drug to prevent pancreatic inflammation and "microlithiasis" in people who have had their gallbladders removed because of gallstones. In this disorder, a sludge of cholesterol-supersaturated bile inflames the bile duct because of its abnormal properties. By restoring the normal properties of bile, the drug would render it less viscous and inflammatory.

While the drug used in the experiments is an expensive experimental compound, said Mangelsdorf, "I have no doubt that the pharmaceutical industry will use these findings as a basis for commercial drug development, provided there are no serious side-effects in humans."
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Contact: Jim Keeley
keeleyj@hhmi.org
301-215-8858
Howard Hughes Medical Institute
22-Nov-2004


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