URSO SUMMARY
URSO 250® (ursodiol, 250 mg) and URSO Forte™ (ursodiol, 500 mg) are available as film-coated tablets for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting white powder consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water.
URSO 250® and URSO Forte™ (ursodiol) tablets are indicated for the treatment of patients with primary biliary cirrhosis.
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NEWS HIGHLIGHTSMedia Articles Related to Urso (Ursodiol)
Less HRT, Fewer Cases of Possible Breast Cancer Precursor
Source: MedicineNet Breast Cancer Specialty [2009.11.13]
Title: Less HRT, Fewer Cases of Possible Breast Cancer Precursor
Category: Health News
Created: 11/12/2009 12:10:00 PM
Last Editorial Review: 11/13/2009
Less HRT, Fewer Cases of Possible Breast Cancer Precursor (HealthDay)
Source: Y! Health Breast Cancer News [2009.11.12]
HealthDay - THURSDAY, Nov. 12 (HealthDay News) -- Declining use of hormone
replacement therapy may be driving down rates of a condition called
"atypical ductal hyperplasia," a known risk factor for breast cancer, new
research suggests.
Placental Precursor Stem Cells Require Testosterone-Free Environment To Survive
Source: Transplants / Organ Donations News From Medical News Today [2009.10.31]
Trophoblast stem cells (TSCs), cells found in the layer of peripheral embryonic stem cells from which the placenta is formed, are thought to exhibit "immune privilege" that aids cell survivability and is potentially beneficial for cell and gene therapies. Further, the survivability of TSCs has been thought to require the presence of ovarian hormones. However, none of these assumptions has ever been verified.
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
Published Studies Related to Urso (Ursodiol)
High-dose ursodeoxycholic acid for the treatment of primary sclerosing cholangitis. [2009.09]
Previous controlled trials are inconclusive regarding the efficacy of ursodeoxycholic acid (UDCA) for treating primary sclerosing cholangitis (PSC). One hundred fifty adult patients with PSC were enrolled in a long-term, randomized, double-blind controlled trial of high-dose UDCA (28-30 mg/kg/day) versus placebo...
Efficacy and safety of ursodeoxycholic acid in primary, type IIa or IIb hypercholesterolemia: a multicenter, randomized, double-blind clinical trial. [2009.04]
BACKGROUND: Ursodeoxycholic acid (UDCA) is a therapeutic bile acid used in dissolution of gallstones and treatment of several cholestatic liver diseases. Results obtained from primary biliary cirrhosis patients treated with UDCA suggested that this agent exerts significant cholesterol-lowering effects and justifies evaluation in primary hypercholesterolemic patients without liver disease. Purpose of this study was to determine whether UDCA had potential to be an effective, safe cholesterol-lowering agent in primary type IIa or IIb hypercholesterolemia... CONCLUSIONS: UDCA did not show intrinsic cholesterol-lowering properties and therefore is not a useful therapy in treating type IIa or type IIb hypercholesterolemic patients. UDCA was confirmed as a well tolerated and safe drug in this population.
Efficacy and safety of ursodeoxycholic acid in primary, type IIa or IIb hypercholesterolemia: A multicenter, randomized, double-blind clinical trial. [2008.08.12]
BACKGROUND: Ursodeoxycholic acid (UDCA) is a therapeutic bile acid used in dissolution of gallstones and treatment of several cholestatic liver diseases. Results obtained from primary biliary cirrhosis patients treated with UDCA suggested that this agent exerts significant cholesterol-lowering effects and justifies evaluation in primary hypercholesterolemic patients without liver disease. Purpose of this study was to determine whether UDCA had potential to be an effective, safe cholesterol-lowering agent in primary type IIa or IIb hypercholesterolemia... CONCLUSIONS: UDCA did not show intrinsic cholesterol-lowering properties and therefore is not a useful therapy in treating type IIa or type IIb hypercholesterolemic patients. UDCA was confirmed as a well tolerated and safe drug in this population.
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.
Ursodeoxycholic acid treatment in preterm infants: a pilot study for the prevention of cholestasis associated with total parenteral nutrition. [2008.02]
In a prospective, double-blind, placebo-controlled trial, the efficacy and safety of ursodeoxycholic acid (UDCA) was evaluated in preterm infants, in terms of its potential impact on fat absorption, advancement of enteral feeding, development of cholestasis, growth, nutritional status, and metabolic status...
Clinical Trials Related to Urso (Ursodiol)
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.
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.
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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