Prognostic factors and long-term effects of ursodeoxycholic acid on liver biochemical parameters in patients with primary biliary cirrhosis
Section snippets
Patients and Methods
A prospective follow-up study of a cohort of PBC patients, who were treated with UDCA according to a pre-defined protocol, was performed. The diagnosis of PBC was established on the basis of previously published criteria (20). Liver biopsy at entry was optional; however, a requirement at entry was that a biopsy specimen had to be available for histological review that showed features compatible with the diagnosis of PBC. The study was started in May, 1990, and follow-up data until 29 February,
Results
The study population consisted of 203 patients; 179 (88%) were female. Five patients tested negative for antimitochondrial antibodies. In all cases histology was compatible with the diagnosis of PBC. A liver biopsy had been obtained in 99 patients within the year before entry; for 16 of the remaining 104 patients cirrhosis had already been documented histologically Table 1.
Median follow-up was 47.3 (10–90 percentile: 10–60) months. Twelve patients (5.9%) who were lost to follow-up were censored
Discussion
In the past, serum bilirubin has been demonstrated to be one of the most important prognostic factors in PBC. This study not only confirms that treatment with UDCA decreases serum levels of bilirubin, but also shows that pre-treatment bilirubin levels remain of significant prognostic value for patients treated with this agent. Most importantly, our results indicate that during treatment serum bilirubin also provides the most powerful prognostic information. This implies that in clinical
Acknowledgements
The other members of the Dutch Multi-Centre PBC Study Group who participated in this study were: R Adang, University Hospital Maastricht; PL Batenburg, Zuiderziekenhuis Rotterdam; J van Hattum, University Hospital Utrecht; P Biemond and LRKW Lie, Ziekenhuis St. Franciscus, Roosendaal; PM Blom van Assendelft, Sophia Ziekenhuis, Zwolle; JGS Breed, St. Jans Gasthuis, Weert; ThJM van Ditzhuijsen and IP van Munster, Bosch Medicentrum, Den Bosch; LGJB Engels, Maasland Ziekenhuis, Sittard; J Ferwerda,
References (29)
- et al.
Effects of ursodeoxycholic acid on survival in patients with primary biliary cirrhosis
Gastroenterology
(1996) - et al.
Combined analysis of randomized controlled trials of ursodeoxycholic acid in primary biliary cirrhosis
Gastroenterology
(1997) - et al.
Ursodeoxycholic acid in the treatment of primary biliary cirrhosis
Gastroenterology
(1994) - et al.
Ursodeoxycholic acid in primary biliary cirrhosis: results of a controlled double-blind trial
Gastroenterology
(1989) - et al.
A randomized, double-blind, placebocontrolled trial of ursodeoxycholic acid in primary biliary cirrhosis
Hepatology
(1995) - et al.
Effects of ursodeoxycholic acid after 4 to 12 years of therapy in early and late stages of primary biliary cirrhosis
J Hepatol
(1994) - et al.
Primary biliary cirrhosis: survival of a large cohort of symptomatic and asymptomatic patients followed for 24 years
J Hepatol
(1994) - et al.
Is the Mayo model for predicting survival useful after the introduction of ursodeoxycholic acid treatment for primary biliary cirrhosis?
Hepatology
(1996) Primary biliary cirrhosis - a first step in prolonging survival
N Engl J Med
(1994)- et al.
Ursodiol for the long-term treatment of primary biliary cirrhosis. The UDCA-PBC Study Group
N Engl J Med
(1994)
The ursodeoxycholic acid story in primary biliary cirrhosis
Gut
The Canadian Multicenter Double-blind Randomized Controlled Trial of ursodeoxycholic acid in primary biliary cirrhosis
Hepatology
A two year controlled trial examining the effectiveness of ursodeoxycholic acid in primary biliary cirrhosis
J Gastroenterol Hepatol
Is primary biliary cirrhosis an autoimmune disease?
Scand J Gastroenterol Suppl
Cited by (42)
The diagnosis of primary biliary cirrhosis
2014, Autoimmunity ReviewsThe long-term effect of ursodeoxycholic acid on laboratory liver parameters in biochemically non-advanced primary biliary cirrhosis
2011, Clinics and Research in Hepatology and GastroenterologyCitation Excerpt :During prolonged treatment bilirubin increases and albumin decreases, but in absolute terms the observed quantitative changes were minor and mean levels of these parameters reflecting liver function remained within normal limits. Previous reports on the early biochemical response after initiating UDCA therapy are in agreement with the present findings [3,4,11]. This study confirms that the most marked laboratory effects are observed within 1–3 years.
Improved Prognosis of Patients With Primary Biliary Cirrhosis That Have a Biochemical Response to Ursodeoxycholic Acid
2009, GastroenterologyCitation Excerpt :Available liver biopsy specimens were reviewed according to Ludwig et al.13 Exclusion criteria were age older than 75 years, pregnancy, evidence of extrahepatic biliary disease, autoimmune overlap syndrome or use of immunosuppressive drugs, concomitant disorders limiting life expectancy, and decompensated PBC, defined as Child–Pugh class B or C cirrhosis. Following inclusion, patients started UDCA therapy at 13–15 mg · kg−1 · day−1.5,14 Follow-up data were collected at 3-month intervals in the first year and at yearly intervals thereafter.
Depression in patients with primary biliary cirrhosis and primary sclerosing cholangitis
2007, Journal of HepatologyCitation Excerpt :One study reported that patients with one or more chronic sicknesses had a 41% increase in the relative risk of having any recent psychiatric illness [5]. Primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC) are chronic cholestatic liver diseases of which PBC has a relatively favourable prognosis for most patients [6–8]. Earlier studies in a population with PBC and PSC found a high prevalence of depression, ranging from 20% to 45% [9–12].
Mitochondrially-mediated toxicity of bile acids
2004, Toxicology