Is the Mayo model for predicting survival useful after the introduction of ursodeoxycholic acid treatment for primary biliary cirrhosis?

Abstract

Treatment of patients with primary biliary cirrhosis eral prognostic indicators have been proposed and (PBC) using ursodeoxycholic acid (UDCA) leads to a re-prognostic indexes developed to predict survival. duction in serum bilirubin. The first objective of this Shapiro et al. 1 showed that serum bilirubin is a good study was to assess the performance of certain prognos-predictor of survival in PBC, and elevated serum bilirutic indicators for PBC after the introduction of treat-bin levels have been used to decide when to refer pament with UDCA. Serum bilirubin is an important prog-tients for transplantation.2 Other groups have develnostic indicator for PBC and an important component oped prognostic indexes that combine bilirubin with of the Mayo model for grading patients into risk categoseveral other variables to arrive at a predictive score. ries. In an analysis of patients enrolled in the CanadianThe European model 3 uses serum bilirubin, serum almulticenter trial, the Mayo score was calculated before bumin, age, the presence of cirrhosis and cholestasis and after treatment with UDCA. After treatment, the Mayo score continued to divide patients with PBC into on liver biopsy, and azathioprine use. The Yale model groups with varying risk. In addition, the serum biliru-combines age, serum bilirubin, hepatomegaly, and the bin alone was shown to do the same even after the intro-presence of portal fibrosis or cirrhosis. 4 A third model duction of treatment with UDCA. A second objective was developed for nonalcoholic cirrhosis and PBC uses seto establish whether UDCA had an effect on long-term rum bilirubin, serum albumin, age, hepatitis B surface The Mayo group 6 devised a further model which emPrimary biliary cirrhosis (PBC) is a chronic progres-ploys serum bilirubin, serum albumin, age, prothromsive cholestatic liver disease for which the only defini-bin time, and the presence of edema. The Mayo model tive treatment is orthotopic liver transplantation. One was based on data from a group of 312 patients inof the most difficult questions in the management of volved in a trial of D-penicillamine and has been exterpatients with PBC is when to intervene with trans-nally cross-validated. 7 plantation to optimize quality and length of life. SevAll of the models mentioned above use the patient's data collected at the time of referral to predict the remaining life span. Both the European and Mayo models Abbreviations: PBC, primary biliary cirrhosis; UDCA, ursodeoxycholic acid.

Long-term ursodeoxycholic acid delays histological progression in primary biliary cirrhosis

“…10 UDCA has also been shown to decrease both the risk of developing esophageal varices 11 and the Mayo risk score, a cross-validated index of survival in PBC. [12][13][14] The effects of UDCA on liver histology are less clear. Using different histological scoring systems, improvement in some histological features such as piecemeal necrosis, 3,8 inflammation, 3,8,15 cholestasis, 3,8 bile duct paucity, and proliferation 3,7,16 have previously been reported in randomized, placebo-controlled trials.…”

Silymarin in the Treatment of Patients With Primary Biliary Cirrhosis With a Suboptimal Response to Ursodeoxycholic Acid

“…In addition, although the effect of silymarin on survival or development of liver-related complications was not the primary end-point of the current study, the Mayo risk score, a cross-validated index of survival in PBC, 11,23,29,32 was not improved; indeed, it increased at the end of the treatment period, further reflecting the lack of a significant effect of silymarin on clinically relevant outcomes. The combination of UDCA and colchicine has shown to be of no benefit for suboptimal responders to UDCA alone in a large, controlled trial.…”

“…Serum bilirubin levels, a useful prognostic marker in treated 29,30 and untreated [23][24][25][26][27][28]31 patients with PBC, were not affected by the combination of UDCA and silymarin, and none of our patients showed a complete normalization of liver biochemistries during combination therapy. In addition, although the effect of silymarin on survival or development of liver-related complications was not the primary end-point of the current study, the Mayo risk score, a cross-validated index of survival in PBC, 11,23,29,32 was not improved; indeed, it increased at the end of the treatment period, further reflecting the lack of a significant effect of silymarin on clinically relevant outcomes.…”

Effect of pretransplantation ursodeoxycholic acid therapy on the outcome of liver transplantation in patients with primary biliary cirrhosis

“…A number of the clinical and biochemical measures used for comparison in this study have previously been shown to be of prognostic value in predicting outcome after liver transplantation. [9][10][11][12]18 There was no difference between UDCA and placebo groups when all pretransplantation prognostic factors were compared, which would suggest that UDCA-treated patients with PBC should have a similar posttransplantation outcome to untreated patients. There was no difference between UDCA and placebo groups with respect to 1-month and 1-year posttransplantation survival and infection.…”