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Cited by 648Liver Diseases and ImmunityDrug Transport and Resistance MechanismsPediatric Hepatobiliary Diseases and Treatments

Combined analysis of randomized controlled trials of ursodeoxycholic acid in primary biliary cirrhosis

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Poupon, RE, Lindor, KD, Cauch-Dudek, K, Dickson, ER, Poupon, R, Heathcote, EJ·1997·Gastroenterology
DOI 10.1016/s0016-5085(97)70183-5
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Abstract

Background & aims Long-term ursodeoxycholic acid (UDCA) therapy slows the progression of primary biliary cirrhosis. This study examined the effect of UDCA therapy on survival free of liver transplantation in a large group of patients.Methods Data from three clinical trials were combined in which patients with primary biliary cirrhosis were randomly assigned to receive UDCA (n = 273) or placebo (n = 275). After 2 years, patients from French and Canadian studies received UDCA for up to 2 years. Patients from the American study remained on their assigned treatment for up to 4 years.Results Survival free of liver transplantation was significantly improved in the patients treated with UDCA compared with the patients originally assigned to placebo (P < 0.001; relative risk, 1.9; 95% confidence interval, 1.3-2.8). Subgroup analyses showed that survival free of liver transplantation was significantly improved in medium- and high-risk groups (serum bilirubin level, 1.4 to 3.5 or > 3.5 mg/dL; P < 0.0001 and P < 0.03, respectively) and histological stage IV subgroup (P < 0.01).Conclusions Long-term UDCA therapy improves survival free of liver transplantation in patients with moderate or severe disease. An effect in patients with mild disease is probably not found because they do not progress to end-stage disease in 4 years.

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  • Some studies with extended follow-up have shown improved survival with UDCA.

    “Some studies with extended follow-up have also shown improved survival.(59,62,63)”

    From Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases (2019) · cites this paper as [63]

    The Discussion reports that four years of UDCA increased survival free of liver transplantation in patients with primary biliary cirrhosis. That supports the extended-follow-up aspect, but the demonstrated outcome includes transplantation; the paper does not establish improved overall survival as the unqualified claim suggests. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • Patients with earlier histologic stage usually respond more favorably to UDCA than patients with advanced disease, although patients with advanced disease may benefit in survival or avoid liver transplantation with this therapy.

    “However, patients with earlier histologic stage usually respond more favorably to UDCA than patients with advanced disease, although patients with advanced disease may benefit in survival or avoid liver transplantation with this therapy.(63)”

    From Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases (2019) · cites this paper as [63]

    The Discussion suggests UDCA might be less efficacious when introduced later in disease, but does not establish that earlier histologic stages usually respond more favorably. For the outcome this study measured, survival free of transplantation, the subgroup analysis found a significant benefit at stage IV but not at stages I–II or III (Figure 3, Discussion). The claim that patients with advanced disease may benefit is supported. (LLM, conf=0.87)

    Experimental — accuracy not yet measured

  • Treatment with ursodeoxycholic acid decreases the levels of biochemical markers of cholestasis and extends the time to liver transplantation.

    “Treatment with ursodeoxycholic acid decreases the levels of the biochemical markers of cholestasis and extends the time to liver transplantation.4,5”

    From A Placebo-Controlled Trial of Bezafibrate in Primary Biliary Cholangitis (2018) · cites this paper as [5]

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Research works printed but not linked: 7

  1. [2]2. Babbs C, Hunt LP, Haoubi NY, Smith A, Rowan BP, Warnes TW. sponse to ursodeoxycholic acid. Gut 1995;36:935-938. Type III procollagen peptide: a marker of disease activity and 15. Christensen E, Crowe JP, Doniach D, Popper H, Ranek L, Rode ´s prognosis in primary biliary cirrhosis. Lancet 1988;1:1021- J, Tygstrup N, Williams R. Clinical pattern and course of disease 1024. in primary biliary cirrhosis based on an analysis of 236 patients.
  2. [3]3. Poupon RE, Balkau B, Gue ´chot J, Heintzmann F. Predictive fac- Gastroenterology 1980;78:236-246. tors in ursodeoxycholic acid-treated patients: role of serum mark- 16.
  3. [4]4. Mahl TC, Shockcor W, Boyer JL. Primary biliary cirrhosis: survival ers of connective tissue. Hepatology 1994;19:635-640. of a large cohort of symptomatic and asymptomatic patients followed for 24 years. J Hepatol 1994;20:701-713.
  4. [5]5. Shapiro JM, Smith H, Schaffner F. Serum bilirubin: a prognostic Received June 20, 1996. Accepted March 14, 1997. factor in primary biliary cirrhosis. Gut 1979;20:137-140. Address requests for reprints to: Rene ´e E. Poupon, Dr. Sci., IN- 18.
  5. [6]6. Roll J, Boyer JL, Barry D, Klatskin G. The prognostic importance SERM Unite ´21, 16, Avenue Paul-Vaillant-Couturier, 94807 Villejuif of clinical and histological features in asymptomatic and symp- Cedex, France. Fax: (33) 01-4726-9454. tomatic primary biliary cirrhosis. N Engl J Med 1983;308:1-7. The authors thank Anne-Marie Bonnand for her helpful discussion
  6. [7]7. Christensen E, Neuberger J, Crowe JP, Altman DG, Popper H, and Christine Gue ´mene ´for her expert technical assistance. Portmann B, Doniach D, Ranek L, Tygstrup N, Williams R. Benefi- Presented, in part, at the 43rd Annual Meeting of the American cial effect of azathioprine and prediction of prognosis in primary Society for the Study of Liver Diseases, May 14-17, 1995, San biliary cirrhosis: final results of an international trial. Gastroenter- ology 1985;89:1084-1091.
  7. [8]8. Brunner of Brunner's Glands Johann Conrad Brunner (1653-1727) was born at Schaffhausen, Switzer- land, near the Rheinfall. He graduated from the university at Strasbourg, and later studied in Paris and then in England under Thomas Willis. He became a professor of anatomy at Heidelberg where he published his Disser- tatio inauguralis de glandulis duodeno intestino in 1687. Actually, Brunner's father-in-law J. J. Wepfer had previously described the glands of the duode- nal mucosa in 1679, but it was Brunner's inaugural dissertation that at- tracted attention, and hence the eponym. / 5E20$$0021 08-08-97 18:15:00 gasas WBS-Gastro

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Authors
Poupon, R., Lindor, K., Cauch-Dudek, K., Dickson, E., Poupon, R., & Heathcote, E.
Affiliations
  • Mayo Clinic (US)
  • Inserm (FR)
Venue
Gastroenterology
Publisher
Elsevier BV
Published
1997-09
Volume
113
Issue
3
Pages
884-890
ISSN
0016-5085 (ISSN-L)
DOI
10.1016/s0016-5085(97)70183-5
OpenAlex
W2071394537
Semantic Scholar
b05e12d331fd48ec432f894f09036aaff9a53c62
Cited by
648
References
0
Citations by year
2026: 12 · 2025: 17 · 2024: 15 · 2023: 9 · 2022: 5 · 2021: 15 · 2020: 21 · 2019: 23 · 2018: 27 · 2017: 26 · 2016: 12 · 2015: 24 · 2014: 26 · 2013: 13 · 2012: 17
FWCI
21.69
Type
journal article
Language
en
Open access
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Gastroenterology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
  • Health Sciences › Medicine › Oncology › Drug Transport and Resistance Mechanisms
  • Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
Keywords
ursodeoxycholic acid, primary biliary cirrhosis, liver transplantation, disease severity, serum bilirubin, subgroup analysis, treatment efficacy
MeSH terms
Adult, Aged, Aged, 80 and over, Cause of Death, Female, Forecasting, Humans, Liver Cirrhosis, Biliary, Male, Middle Aged, Postoperative Care, Severity of Illness Index, Ursodeoxycholic Acid, Survival Analysis, Liver Transplantation, Randomized Controlled Trials as Topic

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