Comparison of three doses of ursodeoxycholic acid in the treatment of primary biliary cirrhosis: A randomized trial

Paul Angulo, E. Rolland Dickson, Terry M. Therneau, Roberta A. Jorgensen, Coleman Smith, Carolee K. Desotel, Stephen M. Lange, Monte L. Anderson, Douglas W. Mahoney, Keith Lindor

Research output: Contribution to journalArticle

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Abstract

Background/Aim: Ursodeoxycholic acid in doses of 13-15 mg · kg-1 · day-1, is a safe and cost-effective treatment for patients with primary biliary cirrhosis. However, very limited information exists regarding the most appropriate dose of ursodeoxycholic acid. The aim of the study was to compare three dosages of ursodeoxycholic acid with respect to changes in liver biochemistries, Mayo risk score, biliary enrichment with ursodeoxycholic acid and side effects over at least a 1-year period. Methods: A total of 155 patients were randomized to receive low- (5-7 mg · kg-1 · day-1), standard-(13-15 mg · kg-1 · day-1), and high- (23-25 mg · kg-1 · day-1) doses of ursodeoxycholic acid. Results: The improvements in alkaline phosphatase (p=0.0001), aspartate aminotransferase (p=0.0001), Mayo risk score (p=0.002), and ursodeoxycholic acid enrichment (p=0.0001) were significantly greater in the standard- and high-dose groups compared to the low-dose group, but not between the standard- and high-dose groups. Changes in serum bilirubin were similar between the three groups (p=0.07). No significant effects on symptoms were noted with any dose. No patients discontinued ursodeoxycholic acid because of side effects or toxicity. Conclusions: Ursodeoxycholic acid in doses of 5-25 mg · kg-1 · day-1 is safe and well tolerated. The dose of 13-15 mg · kg-1 · day-1 appears to be the preferred dose for patients with primary biliary cirrhosis.

Original languageEnglish (US)
Pages (from-to)830-835
Number of pages6
JournalJournal of Hepatology
Volume30
Issue number5
DOIs
StatePublished - May 1999
Externally publishedYes

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Ursodeoxycholic Acid
Biliary Liver Cirrhosis
Therapeutics
Aspartate Aminotransferases
Bilirubin
Health Care Costs
Biochemistry
Alkaline Phosphatase
Liver

Keywords

  • Primary biliary cirrhosis (PBC)
  • Ursodeoxycholic acid (UDCA)

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Comparison of three doses of ursodeoxycholic acid in the treatment of primary biliary cirrhosis : A randomized trial. / Angulo, Paul; Dickson, E. Rolland; Therneau, Terry M.; Jorgensen, Roberta A.; Smith, Coleman; Desotel, Carolee K.; Lange, Stephen M.; Anderson, Monte L.; Mahoney, Douglas W.; Lindor, Keith.

In: Journal of Hepatology, Vol. 30, No. 5, 05.1999, p. 830-835.

Research output: Contribution to journalArticle

Angulo, P, Dickson, ER, Therneau, TM, Jorgensen, RA, Smith, C, Desotel, CK, Lange, SM, Anderson, ML, Mahoney, DW & Lindor, K 1999, 'Comparison of three doses of ursodeoxycholic acid in the treatment of primary biliary cirrhosis: A randomized trial', Journal of Hepatology, vol. 30, no. 5, pp. 830-835. https://doi.org/10.1016/S0168-8278(99)80136-6
Angulo, Paul ; Dickson, E. Rolland ; Therneau, Terry M. ; Jorgensen, Roberta A. ; Smith, Coleman ; Desotel, Carolee K. ; Lange, Stephen M. ; Anderson, Monte L. ; Mahoney, Douglas W. ; Lindor, Keith. / Comparison of three doses of ursodeoxycholic acid in the treatment of primary biliary cirrhosis : A randomized trial. In: Journal of Hepatology. 1999 ; Vol. 30, No. 5. pp. 830-835.
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abstract = "Background/Aim: Ursodeoxycholic acid in doses of 13-15 mg · kg-1 · day-1, is a safe and cost-effective treatment for patients with primary biliary cirrhosis. However, very limited information exists regarding the most appropriate dose of ursodeoxycholic acid. The aim of the study was to compare three dosages of ursodeoxycholic acid with respect to changes in liver biochemistries, Mayo risk score, biliary enrichment with ursodeoxycholic acid and side effects over at least a 1-year period. Methods: A total of 155 patients were randomized to receive low- (5-7 mg · kg-1 · day-1), standard-(13-15 mg · kg-1 · day-1), and high- (23-25 mg · kg-1 · day-1) doses of ursodeoxycholic acid. Results: The improvements in alkaline phosphatase (p=0.0001), aspartate aminotransferase (p=0.0001), Mayo risk score (p=0.002), and ursodeoxycholic acid enrichment (p=0.0001) were significantly greater in the standard- and high-dose groups compared to the low-dose group, but not between the standard- and high-dose groups. Changes in serum bilirubin were similar between the three groups (p=0.07). No significant effects on symptoms were noted with any dose. No patients discontinued ursodeoxycholic acid because of side effects or toxicity. Conclusions: Ursodeoxycholic acid in doses of 5-25 mg · kg-1 · day-1 is safe and well tolerated. The dose of 13-15 mg · kg-1 · day-1 appears to be the preferred dose for patients with primary biliary cirrhosis.",
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T1 - Comparison of three doses of ursodeoxycholic acid in the treatment of primary biliary cirrhosis

T2 - A randomized trial

AU - Angulo, Paul

AU - Dickson, E. Rolland

AU - Therneau, Terry M.

AU - Jorgensen, Roberta A.

AU - Smith, Coleman

AU - Desotel, Carolee K.

AU - Lange, Stephen M.

AU - Anderson, Monte L.

AU - Mahoney, Douglas W.

AU - Lindor, Keith

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N2 - Background/Aim: Ursodeoxycholic acid in doses of 13-15 mg · kg-1 · day-1, is a safe and cost-effective treatment for patients with primary biliary cirrhosis. However, very limited information exists regarding the most appropriate dose of ursodeoxycholic acid. The aim of the study was to compare three dosages of ursodeoxycholic acid with respect to changes in liver biochemistries, Mayo risk score, biliary enrichment with ursodeoxycholic acid and side effects over at least a 1-year period. Methods: A total of 155 patients were randomized to receive low- (5-7 mg · kg-1 · day-1), standard-(13-15 mg · kg-1 · day-1), and high- (23-25 mg · kg-1 · day-1) doses of ursodeoxycholic acid. Results: The improvements in alkaline phosphatase (p=0.0001), aspartate aminotransferase (p=0.0001), Mayo risk score (p=0.002), and ursodeoxycholic acid enrichment (p=0.0001) were significantly greater in the standard- and high-dose groups compared to the low-dose group, but not between the standard- and high-dose groups. Changes in serum bilirubin were similar between the three groups (p=0.07). No significant effects on symptoms were noted with any dose. No patients discontinued ursodeoxycholic acid because of side effects or toxicity. Conclusions: Ursodeoxycholic acid in doses of 5-25 mg · kg-1 · day-1 is safe and well tolerated. The dose of 13-15 mg · kg-1 · day-1 appears to be the preferred dose for patients with primary biliary cirrhosis.

AB - Background/Aim: Ursodeoxycholic acid in doses of 13-15 mg · kg-1 · day-1, is a safe and cost-effective treatment for patients with primary biliary cirrhosis. However, very limited information exists regarding the most appropriate dose of ursodeoxycholic acid. The aim of the study was to compare three dosages of ursodeoxycholic acid with respect to changes in liver biochemistries, Mayo risk score, biliary enrichment with ursodeoxycholic acid and side effects over at least a 1-year period. Methods: A total of 155 patients were randomized to receive low- (5-7 mg · kg-1 · day-1), standard-(13-15 mg · kg-1 · day-1), and high- (23-25 mg · kg-1 · day-1) doses of ursodeoxycholic acid. Results: The improvements in alkaline phosphatase (p=0.0001), aspartate aminotransferase (p=0.0001), Mayo risk score (p=0.002), and ursodeoxycholic acid enrichment (p=0.0001) were significantly greater in the standard- and high-dose groups compared to the low-dose group, but not between the standard- and high-dose groups. Changes in serum bilirubin were similar between the three groups (p=0.07). No significant effects on symptoms were noted with any dose. No patients discontinued ursodeoxycholic acid because of side effects or toxicity. Conclusions: Ursodeoxycholic acid in doses of 5-25 mg · kg-1 · day-1 is safe and well tolerated. The dose of 13-15 mg · kg-1 · day-1 appears to be the preferred dose for patients with primary biliary cirrhosis.

KW - Primary biliary cirrhosis (PBC)

KW - Ursodeoxycholic acid (UDCA)

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