Oral budesonide in the treatment of primary sclerosing cholangitis

Paul Angulo, Kenneth P. Batts, Roberta A. Jorgensen, Nicholas F La Russo, Keith D. Lindor

Research output: Contribution to journalArticle

114 Citations (Scopus)

Abstract

OBJECTIVE: This study was designed to evaluate the safety and estimate the efficacy of oral budesonide in patients with primary sclerosing cholangitis (PSC). METHODS: Twenty-one patients with PSC were treated with 9 mg daily of oral budesonide for 1 yr. RESULTS: Significant, but marginally important, improvement in serum alkaline phosphatase (1235 ± 190 vs 951 ± 206 U/L, p = 0.003) and AST levels (119 ± 14 vs 103 ± 19 U/L, p = 0.02) was noted at the end of the treatment period. Serum bilirubin levels increased significantly in the 18 patients who completed 1 yr of treatment (1.1 ± 0.1 vs 1.4 ± 0.3, p = 0.01) and no significant changes in liver tests were noted 3 months after budesonide was discontinued. The Mayo risk score did not change significantly, and although a significant improvement in the degree of portal inflammation was noted at the end of the treatment period, the degree of fibrosis and stage of disease were not significantly affected. There was a marked loss of bone mass of the femoral neck (0.851 ± 0.02 vs 0.826 ± 0.02 g/cm2, p = 0.002) and lumbar spine (1.042 ± 0.02 vs 1.029 ± 0.02 g/cm2, p = 0.09) at 1 yr of treatment with budesonide. Two patients required evaluation for liver transplantation during treatment, and two patients developed cosmetic side effects. CONCLUSIONS: Oral budesonide appears to be of minimal, if any, benefit and it is associated with a significant worsening of osteoporosis in patients with PSC. (C) 2000 by Am. Coll. of Gastroenterology.

Original languageEnglish (US)
Pages (from-to)2333-2337
Number of pages5
JournalAmerican Journal of Gastroenterology
Volume95
Issue number9
DOIs
StatePublished - 2000

Fingerprint

Budesonide
Sclerosing Cholangitis
Therapeutics
Femur Neck
Gastroenterology
Serum
Bilirubin
Cosmetics
Liver Transplantation
Osteoporosis
Alkaline Phosphatase
Spine
Fibrosis
Inflammation
Safety
Bone and Bones
Liver

ASJC Scopus subject areas

  • Gastroenterology

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Oral budesonide in the treatment of primary sclerosing cholangitis. / Angulo, Paul; Batts, Kenneth P.; Jorgensen, Roberta A.; La Russo, Nicholas F; Lindor, Keith D.

In: American Journal of Gastroenterology, Vol. 95, No. 9, 2000, p. 2333-2337.

Research output: Contribution to journalArticle

Angulo, Paul ; Batts, Kenneth P. ; Jorgensen, Roberta A. ; La Russo, Nicholas F ; Lindor, Keith D. / Oral budesonide in the treatment of primary sclerosing cholangitis. In: American Journal of Gastroenterology. 2000 ; Vol. 95, No. 9. pp. 2333-2337.
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abstract = "OBJECTIVE: This study was designed to evaluate the safety and estimate the efficacy of oral budesonide in patients with primary sclerosing cholangitis (PSC). METHODS: Twenty-one patients with PSC were treated with 9 mg daily of oral budesonide for 1 yr. RESULTS: Significant, but marginally important, improvement in serum alkaline phosphatase (1235 ± 190 vs 951 ± 206 U/L, p = 0.003) and AST levels (119 ± 14 vs 103 ± 19 U/L, p = 0.02) was noted at the end of the treatment period. Serum bilirubin levels increased significantly in the 18 patients who completed 1 yr of treatment (1.1 ± 0.1 vs 1.4 ± 0.3, p = 0.01) and no significant changes in liver tests were noted 3 months after budesonide was discontinued. The Mayo risk score did not change significantly, and although a significant improvement in the degree of portal inflammation was noted at the end of the treatment period, the degree of fibrosis and stage of disease were not significantly affected. There was a marked loss of bone mass of the femoral neck (0.851 ± 0.02 vs 0.826 ± 0.02 g/cm2, p = 0.002) and lumbar spine (1.042 ± 0.02 vs 1.029 ± 0.02 g/cm2, p = 0.09) at 1 yr of treatment with budesonide. Two patients required evaluation for liver transplantation during treatment, and two patients developed cosmetic side effects. CONCLUSIONS: Oral budesonide appears to be of minimal, if any, benefit and it is associated with a significant worsening of osteoporosis in patients with PSC. (C) 2000 by Am. Coll. of Gastroenterology.",
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N2 - OBJECTIVE: This study was designed to evaluate the safety and estimate the efficacy of oral budesonide in patients with primary sclerosing cholangitis (PSC). METHODS: Twenty-one patients with PSC were treated with 9 mg daily of oral budesonide for 1 yr. RESULTS: Significant, but marginally important, improvement in serum alkaline phosphatase (1235 ± 190 vs 951 ± 206 U/L, p = 0.003) and AST levels (119 ± 14 vs 103 ± 19 U/L, p = 0.02) was noted at the end of the treatment period. Serum bilirubin levels increased significantly in the 18 patients who completed 1 yr of treatment (1.1 ± 0.1 vs 1.4 ± 0.3, p = 0.01) and no significant changes in liver tests were noted 3 months after budesonide was discontinued. The Mayo risk score did not change significantly, and although a significant improvement in the degree of portal inflammation was noted at the end of the treatment period, the degree of fibrosis and stage of disease were not significantly affected. There was a marked loss of bone mass of the femoral neck (0.851 ± 0.02 vs 0.826 ± 0.02 g/cm2, p = 0.002) and lumbar spine (1.042 ± 0.02 vs 1.029 ± 0.02 g/cm2, p = 0.09) at 1 yr of treatment with budesonide. Two patients required evaluation for liver transplantation during treatment, and two patients developed cosmetic side effects. CONCLUSIONS: Oral budesonide appears to be of minimal, if any, benefit and it is associated with a significant worsening of osteoporosis in patients with PSC. (C) 2000 by Am. Coll. of Gastroenterology.

AB - OBJECTIVE: This study was designed to evaluate the safety and estimate the efficacy of oral budesonide in patients with primary sclerosing cholangitis (PSC). METHODS: Twenty-one patients with PSC were treated with 9 mg daily of oral budesonide for 1 yr. RESULTS: Significant, but marginally important, improvement in serum alkaline phosphatase (1235 ± 190 vs 951 ± 206 U/L, p = 0.003) and AST levels (119 ± 14 vs 103 ± 19 U/L, p = 0.02) was noted at the end of the treatment period. Serum bilirubin levels increased significantly in the 18 patients who completed 1 yr of treatment (1.1 ± 0.1 vs 1.4 ± 0.3, p = 0.01) and no significant changes in liver tests were noted 3 months after budesonide was discontinued. The Mayo risk score did not change significantly, and although a significant improvement in the degree of portal inflammation was noted at the end of the treatment period, the degree of fibrosis and stage of disease were not significantly affected. There was a marked loss of bone mass of the femoral neck (0.851 ± 0.02 vs 0.826 ± 0.02 g/cm2, p = 0.002) and lumbar spine (1.042 ± 0.02 vs 1.029 ± 0.02 g/cm2, p = 0.09) at 1 yr of treatment with budesonide. Two patients required evaluation for liver transplantation during treatment, and two patients developed cosmetic side effects. CONCLUSIONS: Oral budesonide appears to be of minimal, if any, benefit and it is associated with a significant worsening of osteoporosis in patients with PSC. (C) 2000 by Am. Coll. of Gastroenterology.

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