Ten-year combination treatment with colchicine and ursodeoxycholic acid for primary biliary cirrhosis: A double-blind, placebo-controlled trial on symptomatic patients

P. M. Battezzati, M. Zuin, A. Crosignani, M. Allocca, P. Invernizzi, C. Selmi, E. Villa, M. Podda

Research output: Contribution to journalArticle

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Abstract

Background: Combined medical treatment may provide further benefit to primary biliary cirrhosis (PBC) patients administered ursodeoxycholic acid (UDCA). Aim: To evaluate the long-term effects of colchicine and UDCA in symptomatic PBC patients. Patients/methods: We extended up to 10 years the double-blind treatment of 44 symptomatic PBC patients originally included in a 3-year multicentre study comparing UDCA and colchicine (U + C) versus UDCA and placebo (U + P). Outcome measures were death or liver transplantation; incidence of clinically relevant events; clinical and quantitative variables retaining prognostic information. Results: Mean follow-up was 7 ± 3 years. One patient was lost, three withdrew because of jaundice (U + P); two patients stopped colchicine but remained on UDCA. Eleven patients (two for liver-unrelated reasons. U + P) and six patients (U + C) died, three and two patients, respectively, were transplanted (incidence rate difference, five cases per 100 patient-years; 95% CI, -1 to 11). Hepatocellular carcinoma developed in one (U + P) and four (U + C) patients (difference, -2; CI, -5 to 1). portal hypertension complications in nine patients from each group (difference. 1; CI, -5 to 6). Trends of serum bilirubin, Mayo score, antipyrine clearance were similar among treatment groups. Conclusions: In cirrhotic PBC patients, colchicine does not offer additional benefits to UDCA. In this population, UDCA does not obviate disease progression.

Original languageEnglish (US)
Pages (from-to)1427-1434
Number of pages8
JournalAlimentary Pharmacology and Therapeutics
Volume15
Issue number9
DOIs
StatePublished - 2001
Externally publishedYes

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Ursodeoxycholic Acid
Biliary Liver Cirrhosis
Colchicine
Placebos
Therapeutics
Antipyrine
Incidence
Portal Hypertension
Jaundice
Bilirubin
Liver Transplantation
Multicenter Studies
Disease Progression
Hepatocellular Carcinoma

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Ten-year combination treatment with colchicine and ursodeoxycholic acid for primary biliary cirrhosis : A double-blind, placebo-controlled trial on symptomatic patients. / Battezzati, P. M.; Zuin, M.; Crosignani, A.; Allocca, M.; Invernizzi, P.; Selmi, C.; Villa, E.; Podda, M.

In: Alimentary Pharmacology and Therapeutics, Vol. 15, No. 9, 2001, p. 1427-1434.

Research output: Contribution to journalArticle

Battezzati, P. M. ; Zuin, M. ; Crosignani, A. ; Allocca, M. ; Invernizzi, P. ; Selmi, C. ; Villa, E. ; Podda, M. / Ten-year combination treatment with colchicine and ursodeoxycholic acid for primary biliary cirrhosis : A double-blind, placebo-controlled trial on symptomatic patients. In: Alimentary Pharmacology and Therapeutics. 2001 ; Vol. 15, No. 9. pp. 1427-1434.
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T2 - A double-blind, placebo-controlled trial on symptomatic patients

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AU - Zuin, M.

AU - Crosignani, A.

AU - Allocca, M.

AU - Invernizzi, P.

AU - Selmi, C.

AU - Villa, E.

AU - Podda, M.

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N2 - Background: Combined medical treatment may provide further benefit to primary biliary cirrhosis (PBC) patients administered ursodeoxycholic acid (UDCA). Aim: To evaluate the long-term effects of colchicine and UDCA in symptomatic PBC patients. Patients/methods: We extended up to 10 years the double-blind treatment of 44 symptomatic PBC patients originally included in a 3-year multicentre study comparing UDCA and colchicine (U + C) versus UDCA and placebo (U + P). Outcome measures were death or liver transplantation; incidence of clinically relevant events; clinical and quantitative variables retaining prognostic information. Results: Mean follow-up was 7 ± 3 years. One patient was lost, three withdrew because of jaundice (U + P); two patients stopped colchicine but remained on UDCA. Eleven patients (two for liver-unrelated reasons. U + P) and six patients (U + C) died, three and two patients, respectively, were transplanted (incidence rate difference, five cases per 100 patient-years; 95% CI, -1 to 11). Hepatocellular carcinoma developed in one (U + P) and four (U + C) patients (difference, -2; CI, -5 to 1). portal hypertension complications in nine patients from each group (difference. 1; CI, -5 to 6). Trends of serum bilirubin, Mayo score, antipyrine clearance were similar among treatment groups. Conclusions: In cirrhotic PBC patients, colchicine does not offer additional benefits to UDCA. In this population, UDCA does not obviate disease progression.

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