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Effects of ursodeoxycholic acid on survival in patients with primary biliary cirrhosis
Open accessAbstract
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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“A number of studies have shown the benefit of UDCA in this context.(58)(59)(60)(61)(62)(63) Individual studies have demonstrated consistent evidence of improved liver biochemistries.”
From Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases (2019) · cites this paper as [58]
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- 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.
- 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)
- 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
- bronze
- doi.org
- 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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