Budesonide AKA Prednisone Trials going on............

[Guest guest]

http://www.ncbi.nlm.nih.gov/pubmed/10500075

BACKGROUND & AIMS: Ursodeoxycholic acid (UDCA) is used for treatment of primary

biliary cirrhosis. Previous studies showed that, compared with UDCA monotherapy,

bile salts plus prednisolone had no further effect on laboratory data but

improved liver histology. Thirty percent of these patients had

prednisolone-related side effects. Budesonide is a glucocorticoid with a high

receptor affinity and a high first-pass metabolism. In this study we

investigated whether budesonide and UDCA are superior to UDCA monotherapy.

METHODS: A 2-year prospective, controlled double-blind trial was performed.

Twenty patients (mainly with early-stage disease) were treated with UDCA at a

dose of 10-15 mg/kg daily in addition to 3 mg budesonide 3 times daily (group

A), and 19 patients (1 dropped out for personal reasons) were treated with UDCA

plus placebo (group . Liver biopsy specimens were taken before, after 12

months, and at the end of study. Glucose tolerance tests, serum cortisol levels,

and adrenocorticotropin-stimulated cortisol secretion were assessed at regular

intervals. Bone mass density was measured by dual-energy photon absorptiometry.

RESULTS: Compared with pretreatment values, liver enzyme and immunoglobulin M

and G levels decreased significantly in both groups. Improvement in group A was

significantly more pronounced (P < 0.05) than in group B. Titers of

antimitochondrial antibodies did not change. In group A, the point score of

liver histology improved by 30.3%; in group B, it deteriorated by 3.5% (P <

0.001). Changes in bone mineral density after 2 years were -1.747% in group A

and -0.983% in group B (P = 0.43). Budesonide had little influence on the

hypothalamic-pituitary-adrenal axis. One patient in group A had

budesonide-related side effects; in 3 patients in group B, complications of

liver disease developed. CONCLUSIONS: Combination therapy with UDCA and

budesonide is superior to UDCA and placebo.

PMID: 10500075 [PubMed - indexed for MEDLINE]

Related Articles

a.. Budesonide combined with UDCA to improve liver histology in primary

biliary cirrhosis: a three-year randomized trial. [Hepatology. 2005]

b.. Oral budesonide in the treatment of patients with primary biliary

cirrhosis with a suboptimal response to ursodeoxycholic acid. [Hepatology. 2000]

c.. Budesonide or prednisone in combination with ursodeoxycholic acid in

primary sclerosing cholangitis: a randomized double-blind pilot study.

Belgian-Dutch PSC Study Group. [Am J Gastroenterol. 2000]

d.. ReviewUrsodeoxycholic acid for primary biliary cirrhosis. [Cochrane

Database Syst Rev. 2002]

e.. ReviewMedical treatment of primary biliary cirrhosis and primary

sclerosing cholangitis. [Digestion. 2001]

» See Reviews... | » See All...

____________________________________________________________

See Mexico for less! Click now for great vacation deals!

http://thirdpartyoffers.netzero.net/TGL2241/fc/Ioyw6i4tl0BoOjKWqQNtrbfODp0rF2wvK\

vSE5yuTviqJspp1SoF0SN/