Budesonide or prednisone in combination with ursodeoxycholic acid in primary sclerosing cholangitis: a randomized double-blind pilot study

Hoogstraten, H. J. F. van; Vleggaar, Frank P.; Boland, Greet J.; Steenbergen, Werner Van; Griffioen, Pieter H.; Hop, Wim C. J.; Hattum, Jan van; Henegouwen, G. P. van Berge; Schalm, Solko W.; Buuren, Henk R. van

doi:10.1016/s0002-9270(00)01059-5

Cited by 91 publications

(39 citation statements)

References 33 publications

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“…In contrast, however, a randomized double-blind study with 104 PSC patients conducted by Van Hoogstraten et al [85 ]suggested only minor and short-term benefits on symptoms and liver enzymes with prednisone-UDCA combined treatment, and no benefit with budesonide-UDCA. Finally, a systematic review from the Cochrane Database Collaboration concluded that there were not enough trials available (only 2 were retained) to be able to either refute or support the use of oral steroids in PSC [86].…”

Section: Treatmentmentioning

confidence: 98%

Extraintestinal Manifestations of Crohn’s Disease

et al. 2007

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In each case of extraintestinal manifestations of Crohn’s disease, active disease, if present, should be treated to induce remission, which may positively influence the course of most concomitant extraintestinal manifestations. For some extraintestinal manifestations, however, a specific treatment should be introduced. This latter part of disease management will be discussed in this chapter, in particular for pyoderma gangrenosum, uveitis, spondylarthropathy – axial arthropathy – and primary sclerosing cholangitis, which have also been described in quiescent Crohn’s disease. Few new drugs for the treatment of extraintestinal manifestations of Crohn’s disease have been developed in the past and only the role of infliximab has increased in Crohn’s disease-related extraintestinal manifestations. Drugs specifically aimed at this treatment, stemming from a few randomized controlled studies or case series, are sulfasalazine, 5-ASA, corticosteroids, azathioprine or 6-mercaptopurine, methotrexate, infliximab, adalimumab, etanercept and cyclosporine or tacrolimus. Unfortunately, because of the paucity of data in this field, the best evidence presented and discussed in this article for the treatment of these extraintestinal manifestations is extrapolated from patients that for the most part did not suffer from Crohn’s disease.

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Section: Treatmentmentioning

confidence: 98%

Extraintestinal Manifestations of Crohn’s Disease

et al. 2007

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“…Adding budesonide to UDCA therapy was superior to UDCA alone in a 2-year prospective controlled double-blind study in terms of laboratory values and liver histology [69]. In contrast, however, a randomized double-blind study with 104 PSC patients conducted by van Hoogstraten et al [70] suggested only minor and short-term benefits on symptoms and liver enzymes with prednisone-UDCA combined treatment, and no benefit with budesonide-UDCA.…”

Section: Treatmentmentioning

confidence: 99%

Extraintestinal Manifestations of Crohn’s Disease

et al. 2005

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In each case of extraintestinal manifestations of Crohn’s disease, active disease, if present, should be treated to induce remission, which may positively influence the course of most concomitant extraintestinal manifestations. For some extraintestinal manifestations, however, a specific treatment should be introduced. This latter part of disease management will be discussed in this chapter, in particular for pyoderma gangrenosum, uveitis, spondylarthropathy – axial arthropathy – and primarysclerosing cholangitis, which have also been described in quiescent Crohn’s disease. Few new drugs for the treatment of extraintestinal manifestations of Crohn’s disease have been developed in the past and only the role of infliximab has increased in Crohn’s disease-related extraintestinal manifestations. Drugs specifically aimed at this treatment, stemming from a few randomized controlled studies or case series, are sulfasalazine, 5-ASA, corticosteroids, azathioprine or 6-mercaptopurine, methotrexate, infliximab, dapsone and cyclosporine or tacrolimus.

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“…It might, thereby, at doses high enough to be an effective anti-inflammatory and inducing agent, but lower than those known to induce bone loss in cholestatic patients with early stage disease 81,82 be an effective combination partner of UDCA. Short-term treatment of PSC with budesonide and UDCA over a period of 8 weeks did not reveal a significant additional beneficial effect of budesonide on serum liver tests when compared to UDCA only 85 . Treatment for 1 year revealed improvement of serum liver tests (alkaline phosphatase, AST) and of inflammatory activity around the bile ducts, but an increase of serum bilirubin in a heterogeneous group of PSC patients 86 , Thus, the PXR / GR agonist budesonide may deserve reevaluation at moderate doses in a well-defined subgroup of patients with early stage PSC and accompanying UC.…”

Section: Pxr Agonistsmentioning

confidence: 69%

Medical Treatment of Primary Sclerosing Cholangitis: A Role for Novel Bile Acids and other (post-)Transcriptional Modulators?

Beuers

Kullak‐Ublick

Pusl³

et al. 2008

Clinic Rev Allerg Immunol

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Primary sclerosing cholangitis (PSC) is a rare chronic cholestatic disease of the liver and bile ducts that is associated with inflammatory bowel disease, generally leads to end-stage liver disease, and is complicated by malignancies of the biliary tree and the large intestine. The pathogenesis of PSC remains enigmatic, making the development of targeted therapeutic strategies difficult. Immunosuppressive and antifibrotic therapeutic agents were ineffective or accompanied by major side effects. Ursodeoxycholic acid (UDCA) has consistently been shown to improve serum liver tests and might lower the risk of colon carcinoma and cholangiocarcinoma by yet unknown mechanisms. Whether "high dose" UDCA improves the long-term prognosis in PSC as suggested by small pilot trials remains to be demonstrated. The present overview discusses potential therapeutic options aside of targeted immunological therapies and UDCA. The C23 bile acid norUDCA has been shown to markedly improve biochemical and histological features in a mouse model of sclerosing cholangitis without any toxic effects. Studies in humans are eagerly being awaited. Nuclear receptors like the farnesoid-X receptor (FXR), pregnane-X receptor (PXR), vitamin D receptor (VDR), and peroxisome-proliferator-activator receptors (PPARs) have been shown to induce expression of diverse carriers and biotransformation enzymes of the intestinal and hepatic detoxification machinery and/or to modulate fibrogenesis. Pros and cons of respective receptor agonists for the future treatment of PSC are discussed in detail. In our view, the novel bile acid norUDCA and agonists of PPARs, VDR, and PXR appear particularly attractive for further studies in PSC. Beuers et al.: Future treatment of PSC Clinical Reviews in Allergy and Immunology 2008In press Medical treatment of primary sclerosing cholangitis: AbstractPrimary sclerosing cholangitis (PSC) is a rare chronic cholestatic disease of liver and bile ducts that is associated with inflammatory bowel disease, generally leads to end-stage liver disease and is complicated by malignancies of the biliary tree and the large intestine. The pathogenesis of PSC remains enigmatic making the development of targeted therapeutic strategies difficult. Immunosuppressive and antifibrotic therapeutic agents were ineffective or accompanied by major side effects. Ursodeoxycholic acid (UDCA) has consistently been shown to improve serum liver tests and might lower the risk of colon carcinoma and cholangiocarcinoma by yet unknown mechanisms. Whether "high dose" UDCA improves the long-term prognosis in PSC as suggested by small pilot trials remains to be demonstrated. The present overview discusses potential therapeutic options aside of targeted immunological therapies and UDCA. The C23 bile acid norUDCA has been shown to markedly improve biochemical, and histological features in a mouse model of sclerosing cholangitis without any toxic effects. Studies in humans are eagerly being awaited. Nuclear receptors like the farnesoid-X receptor (FXR), pregna...

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Budesonide or prednisone in combination with ursodeoxycholic acid in primary sclerosing cholangitis: a randomized double-blind pilot study

Abstract: The results of this pilot study suggest only minor beneficial short-term effects of prednisone but not budesonide on symptoms and serum liver tests in UDCA-treated PSC patients.

Cited by 91 publications

References 33 publications

Extraintestinal Manifestations of Crohn’s Disease

Extraintestinal Manifestations of Crohn’s Disease

Extraintestinal Manifestations of Crohn’s Disease

Medical Treatment of Primary Sclerosing Cholangitis: A Role for Novel Bile Acids and other (post-)Transcriptional Modulators?

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