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Cited by 228Liver Diseases and ImmunityPediatric Hepatobiliary Diseases and TreatmentsDrug Transport and Resistance Mechanisms

The DOI matches its Crossref record.

Effects of ursodeoxycholic acid on survival in patients with primary biliary cirrhosis

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Lindor, KD, Therneau, TM, Jorgensen, RA, Malinchoc, M, Dickson, ER·1996·Gastroenterology
DOI 10.1053/gast.1996.v110.pm8613058
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Abstract

Background & aims Ursodeoxycholic acid (UDCA) has been shown to be a safe and effective treatment for patients with primary biliary cirrhosis; however, its effect on patient survival is less certain. To study this issue, the survival of patients receiving long-term UDCA treatment was compared with that of a control group, adjusting for their risk scores based on the Mayo model.Methods One hundred eighty patients were randomized to receive either 13-15 mg.kg-1.day-1 UDCA (n = 89) of placebo (n = 91). After the study closure, the patients originally receiving placebo were switched to active drug, and prospective follow-up was continued for 3 years. Patients were censored at the time of transplantation, voluntary withdrawal, of crossover of the placebo group (efficacy analysis). The survival of the two groups was adjusted for risk scores at the time of entry to the study. A secondary analysis was an intent-to-treat analysis, whereby patients were followed up regardless of their voluntary withdrawal or crossover.Results At the time of analysis, the patients receiving placebo had a significantly increased risk of death and/or requiring transplantation (relative risk, 2.6; P = 0.04) compared with the UDCA-treated patients Conclusions UDCA should be considered as a safe, effective, and life-extending treatment for patients with primary biliary cirrhosis.

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  1. Lindor KD, Dickson ER, Baldus WP, Jorgensen RA, Ludwig J, It is equivalent to removing the placebo curve from Fig- Murtaugh PA, Harrison JM, Wiesner RH, Anderson ML, Lange ure 1 to Figure 4. In our case, the treatment effect is SM, LeSage G, Rossi SS, Hofmann AF. Ursodeoxycholic acid in overstated by 60% (5.9 vs. 3.6). For survival, the placebo the treatment of primary biliary cirrhosis. Gastroenterology 1994; 106:1284-1290. References Gastroenterology, Mayo Foundation, Rochester, Minnesota 55905. Fax: (507) 284-0538.
  2. Poupon RE, Balkau B, Eschwege E, Poupon R, UDCA-PBC Study Presented at the 1995 annual meeting of the American Gastroen- Group. A multicenter, controlled trial of Ursodiol for the treatment terological Association in San Diego, California. of primary biliary cirrhosis. N Engl J Med 1991;324:1548-1554.

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Metadata

Authors
Lindor, K., Therneau, T., Jorgensen, R., Malinchoc, M., & Dickson, E.
Affiliations
Mayo Clinic (US)
Venue
Gastroenterology
Publisher
Elsevier BV
Published
1996-05
Volume
110
Issue
5
Pages
1515-1518
ISSN
0016-5085 (ISSN-L)
DOI
10.1053/gast.1996.v110.pm8613058
OpenAlex
W2075432722
Cited by
228
References
0
Citations by year
2026: 2 · 2025: 4 · 2024: 7 · 2023: 1 · 2022: 2 · 2021: 4 · 2020: 6 · 2019: 8 · 2018: 4 · 2017: 5 · 2016: 5 · 2015: 11 · 2014: 10 · 2013: 9 · 2012: 5
FWCI
11.48
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 › Surgery › Pediatric Hepatobiliary Diseases and Treatments
  • Health Sciences › Medicine › Oncology › Drug Transport and Resistance Mechanisms
Keywords
ursodeoxycholic acid, primary biliary cirrhosis, survival, mortality, liver transplantation, Mayo risk score, long-term treatment, intention-to-treat analysis
MeSH terms
Adult, Double-Blind Method, Female, Follow-Up Studies, Humans, Liver Cirrhosis, Biliary, Male, Middle Aged, Prospective Studies, Ursodeoxycholic Acid, Survival Rate, Proportional Hazards Models, Liver Transplantation

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