Incomplete response to ursodeoxycholic acid in primary biliary cirrhosis: Is a double dosage worthwhile?

Paul Angulo, Roberta A. Jorgensen, Keith Lindor

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Abstract

OBJECTIVE: The aim of this study was to assess the safety and efficacy of high-dose ursodeoxycholic acid (UDCA, 28-32 mg/kg/day) in patients with primary biliary cirrhosis (PBC) who had shown an incomplete response to the standard dose (13-15 mg/kg/day). METHODS: A total of 25 patients with PBC who had been on UDCA (13-15 mg/kg/day) therapy for 24-141 months and had shown persistent elevation of ALP activity at least two times the upper limit of normal were enrolled. The dose of UDCA was increased to 30 (28-32) mg/kg/day and given for 1 yr. RESULTS: A significant but marginal improvement in serum ALP activity (707 ± 52 vs 571 ± 32, p = 0.001) was noted at 1 yr of treatment with high-dose UDCA. However, levels of total bilirubin (1.1 ± 0.2 vs 1.0 ± 0.2, p = 0.1), AST (58 ± 9 vs 54 ± 11, p = 0.1), albumin (4.1 ± 0.7 vs 4.0 ± 0.08, p = 0.1), or Mayo risk score (4.13 ± 0.3 vs 4.12 ± 0.3, p = 0.2) remained essentially unchanged. Normalization of liver tests did not occur in any patient, and adverse events were not recorded in any case. CONCLUSIONS: Although UDCA at a dose of 28-32 mg/kg/day is well tolerated, this dosage does not seem to benefit most patients with PBC responding incompletely to a dose of 13-15 mg/kg/day. The results of this pilot study would seem to discourage further controlled trials of high-dose UDCA in suboptimal responders to the standard dose of UDCA.

Original languageEnglish (US)
Pages (from-to)3152-3157
Number of pages6
JournalAmerican Journal of Gastroenterology
Volume96
Issue number11
DOIs
StatePublished - 2001
Externally publishedYes

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Ursodeoxycholic Acid
Biliary Liver Cirrhosis
Bilirubin
Albumins
Safety
Liver
Therapeutics
Serum

ASJC Scopus subject areas

  • Gastroenterology

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Incomplete response to ursodeoxycholic acid in primary biliary cirrhosis : Is a double dosage worthwhile? / Angulo, Paul; Jorgensen, Roberta A.; Lindor, Keith.

In: American Journal of Gastroenterology, Vol. 96, No. 11, 2001, p. 3152-3157.

Research output: Contribution to journalArticle

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title = "Incomplete response to ursodeoxycholic acid in primary biliary cirrhosis: Is a double dosage worthwhile?",
abstract = "OBJECTIVE: The aim of this study was to assess the safety and efficacy of high-dose ursodeoxycholic acid (UDCA, 28-32 mg/kg/day) in patients with primary biliary cirrhosis (PBC) who had shown an incomplete response to the standard dose (13-15 mg/kg/day). METHODS: A total of 25 patients with PBC who had been on UDCA (13-15 mg/kg/day) therapy for 24-141 months and had shown persistent elevation of ALP activity at least two times the upper limit of normal were enrolled. The dose of UDCA was increased to 30 (28-32) mg/kg/day and given for 1 yr. RESULTS: A significant but marginal improvement in serum ALP activity (707 ± 52 vs 571 ± 32, p = 0.001) was noted at 1 yr of treatment with high-dose UDCA. However, levels of total bilirubin (1.1 ± 0.2 vs 1.0 ± 0.2, p = 0.1), AST (58 ± 9 vs 54 ± 11, p = 0.1), albumin (4.1 ± 0.7 vs 4.0 ± 0.08, p = 0.1), or Mayo risk score (4.13 ± 0.3 vs 4.12 ± 0.3, p = 0.2) remained essentially unchanged. Normalization of liver tests did not occur in any patient, and adverse events were not recorded in any case. CONCLUSIONS: Although UDCA at a dose of 28-32 mg/kg/day is well tolerated, this dosage does not seem to benefit most patients with PBC responding incompletely to a dose of 13-15 mg/kg/day. The results of this pilot study would seem to discourage further controlled trials of high-dose UDCA in suboptimal responders to the standard dose of UDCA.",
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T1 - Incomplete response to ursodeoxycholic acid in primary biliary cirrhosis

T2 - Is a double dosage worthwhile?

AU - Angulo, Paul

AU - Jorgensen, Roberta A.

AU - Lindor, Keith

PY - 2001

Y1 - 2001

N2 - OBJECTIVE: The aim of this study was to assess the safety and efficacy of high-dose ursodeoxycholic acid (UDCA, 28-32 mg/kg/day) in patients with primary biliary cirrhosis (PBC) who had shown an incomplete response to the standard dose (13-15 mg/kg/day). METHODS: A total of 25 patients with PBC who had been on UDCA (13-15 mg/kg/day) therapy for 24-141 months and had shown persistent elevation of ALP activity at least two times the upper limit of normal were enrolled. The dose of UDCA was increased to 30 (28-32) mg/kg/day and given for 1 yr. RESULTS: A significant but marginal improvement in serum ALP activity (707 ± 52 vs 571 ± 32, p = 0.001) was noted at 1 yr of treatment with high-dose UDCA. However, levels of total bilirubin (1.1 ± 0.2 vs 1.0 ± 0.2, p = 0.1), AST (58 ± 9 vs 54 ± 11, p = 0.1), albumin (4.1 ± 0.7 vs 4.0 ± 0.08, p = 0.1), or Mayo risk score (4.13 ± 0.3 vs 4.12 ± 0.3, p = 0.2) remained essentially unchanged. Normalization of liver tests did not occur in any patient, and adverse events were not recorded in any case. CONCLUSIONS: Although UDCA at a dose of 28-32 mg/kg/day is well tolerated, this dosage does not seem to benefit most patients with PBC responding incompletely to a dose of 13-15 mg/kg/day. The results of this pilot study would seem to discourage further controlled trials of high-dose UDCA in suboptimal responders to the standard dose of UDCA.

AB - OBJECTIVE: The aim of this study was to assess the safety and efficacy of high-dose ursodeoxycholic acid (UDCA, 28-32 mg/kg/day) in patients with primary biliary cirrhosis (PBC) who had shown an incomplete response to the standard dose (13-15 mg/kg/day). METHODS: A total of 25 patients with PBC who had been on UDCA (13-15 mg/kg/day) therapy for 24-141 months and had shown persistent elevation of ALP activity at least two times the upper limit of normal were enrolled. The dose of UDCA was increased to 30 (28-32) mg/kg/day and given for 1 yr. RESULTS: A significant but marginal improvement in serum ALP activity (707 ± 52 vs 571 ± 32, p = 0.001) was noted at 1 yr of treatment with high-dose UDCA. However, levels of total bilirubin (1.1 ± 0.2 vs 1.0 ± 0.2, p = 0.1), AST (58 ± 9 vs 54 ± 11, p = 0.1), albumin (4.1 ± 0.7 vs 4.0 ± 0.08, p = 0.1), or Mayo risk score (4.13 ± 0.3 vs 4.12 ± 0.3, p = 0.2) remained essentially unchanged. Normalization of liver tests did not occur in any patient, and adverse events were not recorded in any case. CONCLUSIONS: Although UDCA at a dose of 28-32 mg/kg/day is well tolerated, this dosage does not seem to benefit most patients with PBC responding incompletely to a dose of 13-15 mg/kg/day. The results of this pilot study would seem to discourage further controlled trials of high-dose UDCA in suboptimal responders to the standard dose of UDCA.

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