Chenodiol Brand Name– Chenodal
What is Chenodiol
Chenodiol is the oral formulation of chenodeoxycholic acid, a naturally occurring human bile acid.
It is indicated for adult patients with radiolucent stones in well-opacifying gallbladders, in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age.
Chenodiol therapy is most effective in patients whose gallstones are floatable or small. For patients with non-floatable stones, the risk of unsuccessful medical treatment should be weighed against the risks associated with postponed surgical intervention.
Efficacy and many of the safety concerns are dose-dependant. In the National Cooperative Gallstone Study (NCGS), involving 305 patients in each treatment group, placebo and chenodiol dosages of 375 mg and 750 mg per day were associated with complete stone dissolution in 0.8%, 5.2%, and 13.5%, respectively, of enrolled subjects over 24 months.
Uncontrolled clinical trials using higher doses than those used in the NCGS have shown complete dissolution rates of 28% to 38% of enrolled patients who received weight-based doses of 13—16 mg/kg/day for up to 24 months.
The safety of chenodiol use beyond 24 months has not be established. It is estimated that half of chenodiol-treated patients will experience stone recurrence within 5 years.
Retreatment with chenodiol has proven successful in dissolving some newly formed stones; however, the safety of retreatment has not been established. Dose-dependant adverse events such as serum aminotransferase elevations and diarrhea have been observed in all clinical trials.
Furthermore, chenodiol therapy has been associated with hepatotoxicity.
Chenodiol should be reserved for carefully selected patients, and treated individuals must be counseled on the importance of diligent monitoring including systematic liver function test as well as periodic oral cholecystograms or ultrasonograms and cholesterol tests.
Chenix (chenodeoxycholic acid) tablets 250 mg were originally FDA approved in 1983 and became the reference listed drug with the FDA.
Chenix brand tablets are no longer marketed in the US, but Chenodal (chenodiol tablets) were determined to be bioequivalent and therefore, therapeutically equivalent to the reference listed drug.
Accordingly, Chenodal (chenodiol) tablets were FDA approved in October 2009.
For treatment of cholelithiasis via the dissolution of radiolucent cholesterol gallstones
NOTE: Chenodiol is indicated for use in patients with radiolucent stones who are ineligible for surgery because of systemic disease or age. Successful dissolution of stones is more likely in patients presenting with small or floatable stones; for patients with non-floatable stones, the risk of unsuccessful medical treatment should be weighed against the risk of postponed surgical intervention.
NOTE: Chenodiol will not dissolve calcified (radiopaque) or radiolucent bile pigment stones.
- abdominal pain
- elevated hepatic enzymes
- fecal urgency
- hepatic failure
- new primary malignancy
- pyrosis (heartburn)
- gallbladder ultrasound
- serum cholesterol
- bile acid agents hypersensitivity
- biliary cirrhosis
- biliary obstruction
- biliary tract disease
- biliary-GI fistula
- gallbladder disease
- hepatic disease
- new primary malignancy
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