High-dose ursodeoxycholic acid in primary sclerosing cholangitis: a 5-year multicenter, randomized, controlled study.

@article{Olsson2005HighdoseUA,
  title={High-dose ursodeoxycholic acid in primary sclerosing cholangitis: a 5-year multicenter, randomized, controlled study.},
  author={Rolf Olsson and Kirsten Muri Boberg and O S de Muckadell and Stefan C. Lindgren and Rolf Hultcrantz and Geir Folvik and Helge Bell and Magnhild Gangs{\o}y-Kristiansen and Jon Matre and Andreas Rydning and Ola Wikman and {\AA}ke Danielsson and Hanna Sandberg-Gertz{\'e}n and K A Ung and Anders S Eriksson and Lars L{\"o}{\"o}f and Hanne Prytz and Hanns-Ulrich Marschall and Ulrika Broomé},
  journal={Gastroenterology},
  year={2005},
  volume={129 5},
  pages={
          1464-72
        }
}
BACKGROUND & AIMS There is no medical treatment of proven benefit for primary sclerosing cholangitis. This study aimed at studying the effect of a higher dose of ursodeoxycholic acid than previously used on survival, symptoms, biochemistry, and quality of life in this disease. METHODS A randomized placebo-controlled study was performed in tertiary and secondary gastroenterology units. A total of 219 patients were randomized to 17 to 23 mg/kg body weight per day of ursodeoxycholic acid (n… 

Figures from this paper

Urosdeoxycholic acid in primary sclerosing cholangitis: a meta-analysis and systematic review.

  • M. OthmanJ. DunkelbergP. Roy
  • Medicine
    Arab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology
  • 2012

Bile acid changes after high‐dose ursodeoxycholic acid treatment in primary sclerosing cholangitis: Relation to disease progression

High‐dose UDCA treatment in PSC patients results in marked UDCA enrichment and significant expansion of the total serum bile acid pool, including LCA.

A randomized, placebo-controlled, phase II study of obeticholic acid for primary sclerosing cholangitis

Treatment with OCA 5–10 mg reduced serum ALP in patients with PSC and no new safety signals emerged, and total bilirubin remained comparable to baseline in all groups.

A Randomized, Dose-Finding, Proof-of-Concept Study of Berberine Ursodeoxycholate in Patients With Primary Sclerosing Cholangitis

HTD1801 is associated with significant improvement in ALP and warrants further study as a treatment for PSC, and was generally well tolerated.

Prospective evaluation of ursodeoxycholic acid withdrawal in patients with primary sclerosing cholangitis

At 3 months, discontinuation of UDCA in patients with PSC causes significant deterioration in liver biochemistry and influences concentrations of bile acid metabolites, but other short‐term markers of quality of life are unaffected.

University of Birmingham norUrsodeoxycholic acid improves cholestasis in primary sclerosing cholangitis

A randomized controlled trial, including 38 centers from 12 European countries, evaluated the safety and efficacy of three doses of oral nor UDCA compared with placebo in patients with PSC and found the safety was excellent and comparable to placebo.

The Effect of Ursodeoxycholic Acid in Liver Functional Restoration of Patients with Obstructive Jaundice after Endoscopic Treatment: A Randomized Controlled Trial

UDCA has accelerated reducing the level of total bilirUBin, direct bilirubin, GGT, and neutrophil/lymphocyte ratio, but did not decrease the levelof ALT, AST, and alkaline phosphatase, and did not induce increasing of albumin level.

norUrsodeoxycholic acid improves cholestasis in primary sclerosing cholangitis.

...

References

SHOWING 1-10 OF 48 REFERENCES

Treatment of primary sclerosing cholangitis with low-dose ursodeoxycholic acid: results of a retrospective Italian multicentre survey.

  • L. OkolicsànyiM. Groppo M. Zuin
  • Medicine, Biology
    Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
  • 2003

A preliminary trial of high-dose ursodeoxycholic acid in primary sclerosing cholangitis.

High-dose UDCA may be of clinical benefit in PSC, but trials with a larger number of participants and of longer duration are required to establish whether the effect of high- dose UDCA on liver biochemistry, histology, and cholangiography in patients with PSC is translated into improved long-term survival.

High-dose ursodeoxycholic acid as a therapy for patients with primary sclerosing cholangitis

UDCA at a dose of 25–30 mg/kg per day may be of benefit for patients with PSC, and this regimen deserves further evaluation in a long-term, randomized, placebo-controlled trial.

Ursodeoxycholic acid for treatment of primary sclerosing cholangitis: A placebo‐controlled trial

It is concluded that ursodeoxycholic acid is beneficial in reducing disease activity in patients with primary sclerosing cholangitis and histopathological features improved significantly, as evaluated by multiparametric score.

Ursodiol for primary sclerosing cholangitis. Mayo Primary Sclerosing Cholangitis-Ursodeoxycholic Acid Study Group.

  • K. Lindor
  • Medicine
    The New England journal of medicine
  • 1997
In a group of patients with well-defined primary sclerosing cholangitis, ursodiol provided no clinical benefit and was associated with improvement in serum alkaline phosphatase, aspartate aminotransferase, bilirubin, and albumin levels at one and two years.

Ursodiol for Primary Sclerosing Cholangitis

Ursodiol (ursodeoxycholic acid) benefits patients with primary biliary cirrhosis, another cholestatic liver disease, and well-documented primary sclerosing cholangitis in a randomized, double-blind study comparing ursodiol with placebo.

Ursodeoxycholic acid does not improve the clinical course of primary sclerosing cholangitis over a 2-year period.

Neither ursodeoxycholic acid or colchicine can be considered to be effective therapies for primary sclerosing cholangitis, as no difference in ERCP findings was evident between groups either at entry or after two years of therapy.

Metronidazole and ursodeoxycholic acid for primary sclerosing cholangitis: A randomized placebo‐controlled trial

Combining MTZ with UDCA in PSC improved serum ALP levels and New Mayo Risk Score, but no statistically significant effect on disease progression as assessed via liver histology or ERCP was seen.

Ursodeoxycholic acid for the treatment of primary sclerosing cholangitis: A 30‐month pilot study

The effects of once‐daily oral administration of ursodeoxycholic acid (generic name, ursodiol) on elevated serum enzyme activities, bilirubin, cholesterol, bile acids and symptoms in patients with primary sclerosing cholangitis is investigated.