Actigall (Ursodiol) - Summary

ACTIGALL SUMMARY

Actigall is a bile acid available as 300-mg capsules suitable for oral administration. Actigall is ursodiol USP (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water.

1. Actigall is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Actigall beyond 24 months is not established.

2. Actigall is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

NEWS HIGHLIGHTS

Media Articles Related to Actigall (Ursodiol)

Primary Biliary Cirrhosis
Source: MedicineNet ursodiol Specialty [2005.09.17]
Title: Primary Biliary Cirrhosis
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 9/17/2005

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Published Studies Related to Actigall (Ursodiol)

Clinical Trial: Randomized controlled trial of zidovudine and lamivudine for patients with primary biliary cirrhosis stabilized on ursodiol. [2008.07.09]
Background: A human betaretrovirus has been characterized in patients with primary biliary cirrhosis (PBC)... Accordingly, more potent anti-viral regimens will be required to confirm the efficacy of antiviral therapy in PBC patients with human betaretrovirus infection.

Ursodiol in patients with parenteral nutrition-associated cholestasis. [2007.11]
CONCLUSIONS: Ursodiol may improve the biochemical signs and clinical symptoms of PNAC. However, optimal dosing, timing, duration of therapy, and long-term effects on PNAC outcome and prognosis require further studies.

Ursodiol in Patients with Parenteral Nutrition-Associated Cholestasis (November). [2007.10.02]
CONCLUSIONS: Ursodiol may improve the biochemical signs and clinical symptoms of PNAC. However, optimal dosing, timing, duration of therapy, and long-term effects on PNAC outcome and prognosis require further studies.

Ursodiol use is possibly associated with lower incidence of hepatocellular carcinoma in hepatitis C virus-associated liver cirrhosis. [2005.01]
In a previous study of patients with hepatitis C virus (HCV)-associated liver cirrhosis (HCV-LC), we showed that increased liver inflammation, as assessed by higher serum alanine aminotransferase (ALT), was associated with increased risk for the development of hepatocellular carcinoma (HCC)... Interestingly, because the serum ALT trends over time were nearly the same in both groups, the chemopreventive effectiveness of UDCA was not accompanied by greater reductions in ALT compared with the UDCA nonusers.

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Clinical Trials Related to Actigall (Ursodiol)

Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates [Recruiting]
The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.

Ursodiol in Huntington's Disease [Recruiting]
The purpose of this study is to evaluate the safety of the drug ursodiol (ursodeoxycholic acid, UDCA) in people with Huntington's disease (HD) and to explore how the compound is processed by the body.

Trial of High-Dose Urso in Primary Sclerosing Cholangitis [Completed]
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplanation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.

Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients [Completed]
Malignant transformation of adenomas of the duodenum is now the leading cause of death in familial adenomatous polyposis (FAP) patients who had a restorative proctocolectomy. Ursodeoxycholic acid (UDCA) modifies the biliary acid profile and could reduce the severity of duodenal adenomas and prevent such transformation.

Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC) [Recruiting]
The study is aimed to compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. Depending on ALT values 6 mg/d budesonide are allowed. The study population will be patients with PBC at risk for disease progression. It is assumed that the combination therapy will result in a decrease of treatment failures after 3 years of treatment.

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