Influence of ursodeoxycholic acid on the mortality and malignancy associated with primary biliary cirrhosis: a population-based cohort study.
There is debate over the mortality and malignancy risk in people with primary biliary cirrhosis (PBC) and whether this risk is reduced by use of ursodeoxycholic acid. To investigate this issue, we identified 930 people with PBC and 9,202 control subjects from the General Practice Research Database in the United Kingdom. We categorized regular ursodeoxycholic acid as treatment with 6 or more prescriptions and nonregular treatment as less than 6. We found a 2.7-fold increase in mortality for the PBC cohort compared with the general population [adjusted hazard ratio (HR), 2.69; 95% CI, 2.35-3.09]. In those having regular ursodeoxycholic acid (43%), the mortality increase was 2.2-fold (HR, 2.19; 95% CI, 1.66-2.87) and in those not treated 2.7-fold (HR, 2.69; 95% CI, 2.18-3.33). This apparent reduction in mortality was not explained by less severe disease in the ursodeoxycholic acid-treated group. The increased risk of primary liver cancer in ursodeoxycholic acid-treated patients was 3-fold (HR, 3.17; 95% CI, 0.64-15.62), in contrast to an 8-fold increase in those not treated (HR, 7.77; 95% CI, 1.30-46.65).


CONCLUSIONS
We found that people with PBC had a 3-fold mortality increase when compared with the general population, which was somewhat reduced by regular treatment with ursodeoxycholic acid. However, the observed effect of ursodeoxycholic acid was not statistically significant.
Jackson
Hannah
H
University of Nottingham Medical School, Division of Epidemiology and Public Health, Medical School, Queen's Medical Centre, Nottingham, United Kingdom.
Solaymani-Dodaran
Masoud
M
Card
Tim R
TR
Aithal
Guruprasad P
GP
Logan
Richard
R
West
Joe
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008105:Liver Cirrhosis, Biliary / Q000188:drug therapy* / Q000401:mortality*; D008113:Liver Neoplasms / Q000453:epidemiology*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D012307:Risk Factors; D012720:Severity of Illness Index; D006113:United Kingdom / Q000453:epidemiology; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
D002756:Cholagogues and Choleretics; D014580:Ursodeoxycholic Acid